find a remote job
work from anywhere

Get new remote Assembly + Senior + Travel jobs sent to

Subscribe
×
๐Ÿ‘ฉโ€๐Ÿ’ป Join Remote OK ๐Ÿ‘‹  Log in
General
Remote OK Frontpage ๐Ÿ Remote jobs ๐ŸŒ—  Dark mode ๐Ÿ‘ฉโ€๐Ÿ’ป Hire remote workers ๐Ÿšจ Post a remote job ๐Ÿฑ Compact mode โœ๏ธ Remote work blog new
Top jobs
๐Ÿฆพ  AI Jobs
โฐ Async jobs ๐ŸŒŽ Distributed team ๐Ÿค“ Engineer jobs ๐Ÿ’ผ Executive jobs ๐Ÿ‘ต Senior jobs ๐Ÿค“ Developer jobs ๐Ÿ’ฐ Finance jobs โ™พ๏ธ Sys Admin jobs โ˜•๏ธ JavaScript jobs ๐Ÿ‘ Backend jobs
Companies
๐Ÿšจ Post a remote job ๐Ÿ“ฆ Buy a job bundle ๐Ÿท Ask for a discount Safetywing Health insurance for teams Safetywing Health insurance for nomads
Feeds
๐Ÿ›  Remote Jobs API ๐Ÿชš  RSS feed ๐Ÿช“  JSON feed

Hacker News mode  Hacker News mode

Safe for work mode  Safe for work mode

Other
๐ŸŸข  Uptime (99.93%) ๐Ÿ“ˆ  Pageviews (2.66M/mo) ๐Ÿ“Š Remote work stats new ๐Ÿ‘ท Top remote companies ๐Ÿ’ฐ Highest paying remote jobs ๐Ÿงช State of remote work new
๐ŸŒ  Become a digital nomad
๐Ÿ”ฎ  Web3 Jobs
๐Ÿก  Interior AI
๐Ÿ‘ฑโ€โ™€๏ธ  AI Avatars
๐Ÿ“ธ  Photo AI
๐Ÿ‡ต๐Ÿ‡น  Get Portuguese residency new
Post a remote job Log in

๐Ÿ‘‰ Hiring for a Remote Assembly + Senior + Travel position?

Post a job
on the ๐Ÿ† #1 Remote Jobs board.
Minimum
$0k/year
๐Ÿ’ฐ 401(k)
๐ŸŒŽ Distributed team
โฐ Async
๐Ÿค“ Vision insurance
๐Ÿฆท Dental insurance
๐Ÿš‘ Medical insurance
๐Ÿ– Unlimited vacation
๐Ÿ– Paid time off
๐Ÿ“† 4 day workweek
๐Ÿ’ฐ 401k matching
๐Ÿ” Company retreats
๐Ÿฌ Coworking budget
๐Ÿ“š Learning budget
๐Ÿ’ช Free gym membership
๐Ÿง˜ Mental wellness budget
๐Ÿ–ฅ Home office budget
๐Ÿฅง Pay in crypto
๐Ÿฅธ Pseudonymous
๐Ÿ’ฐ Profit sharing
๐Ÿ’ฐ Equity compensation
โฌœ๏ธ No whiteboard interview
๐Ÿ‘€ No monitoring system
๐Ÿšซ No politics at work
๐ŸŽ… We hire old (and young)
Regions
๐ŸŒ Worldwide
โ›ฐ๏ธ North America
๐Ÿ’ƒ Latin America
๐Ÿ‡ช๐Ÿ‡บ Europe
๐Ÿฆ Africa
๐Ÿ•Œ Middle East
โ›ฉ Asia
๐ŸŒŠ Oceania
Countries
๐Ÿ‡บ๐Ÿ‡ธ United States
๐Ÿ‡จ๐Ÿ‡ฆ Canada
๐Ÿ‡ฌ๐Ÿ‡ง United Kingdom
๐Ÿ‡ฆ๐Ÿ‡บ Australia
๐Ÿ‡ณ๐Ÿ‡ฟ New Zealand
๐Ÿ‡ฎ๐Ÿ‡ณ India
๐Ÿ‡ต๐Ÿ‡น Portugal
๐Ÿ‡ฉ๐Ÿ‡ช Germany
๐Ÿ‡ณ๐Ÿ‡ฑ Netherlands
๐Ÿ‡ธ๐Ÿ‡ฌ Singapore
๐Ÿ‡ซ๐Ÿ‡ท France
๐Ÿ‡ญ๐Ÿ‡ฐ Hong Kong
๐Ÿ‡ง๐Ÿ‡ท Brazil
๐Ÿ‡ฌ๐Ÿ‡ท Greece
๐Ÿ‡ฆ๐Ÿ‡ช United Arab Emirates
๐Ÿ‡ธ๐Ÿ‡ช Sweden
๐Ÿ‡ต๐Ÿ‡ฑ Poland
๐Ÿ‡ช๐Ÿ‡ธ Spain
๐Ÿ‡ฒ๐Ÿ‡ฝ Mexico
๐Ÿ‡บ๐Ÿ‡ฆ Ukraine
๐Ÿ‡ฏ๐Ÿ‡ต Japan
๐Ÿ‡น๐Ÿ‡ญ Thailand
๐Ÿ‡จ๐Ÿ‡ฟ Czechia
๐Ÿ‡ท๐Ÿ‡บ Russia
๐Ÿ‡ฎ๐Ÿ‡ฑ Israel
๐Ÿ‡ซ๐Ÿ‡ฎ Finland
๐Ÿ‡จ๐Ÿ‡ณ China
๐Ÿ‡ฎ๐Ÿ‡ฉ Indonesia
๐Ÿ‡ฆ๐Ÿ‡ซ Afghanistan
๐Ÿ‡ฆ๐Ÿ‡ฑ Albania
๐Ÿ‡ฉ๐Ÿ‡ฟ Algeria
๐Ÿ‡ฆ๐Ÿ‡ธ American Samoa
๐Ÿ‡ฆ๐Ÿ‡ฉ Andorra
๐Ÿ‡ฆ๐Ÿ‡ด Angola
๐Ÿ‡ฆ๐Ÿ‡ฎ Anguilla
๐Ÿ‡ฆ๐Ÿ‡ถ Antarctica
๐Ÿ‡ฆ๐Ÿ‡ฌ Antigua and Barbuda
๐Ÿ‡ฆ๐Ÿ‡ท Argentina
๐Ÿ‡ฆ๐Ÿ‡ฒ Armenia
๐Ÿ‡ฆ๐Ÿ‡ผ Aruba
๐Ÿ‡ฆ๐Ÿ‡น Austria
๐Ÿ‡ฆ๐Ÿ‡ฟ Azerbaijan
๐Ÿ‡ง๐Ÿ‡ธ The Bahamas
๐Ÿ‡ง๐Ÿ‡ญ Bahrain
๐Ÿ‡ง๐Ÿ‡ฉ Bangladesh
๐Ÿ‡ง๐Ÿ‡ง Barbados
๐Ÿ‡ง๐Ÿ‡พ Belarus
๐Ÿ‡ง๐Ÿ‡ช Belgium
๐Ÿ‡ง๐Ÿ‡ฟ Belize
๐Ÿ‡ง๐Ÿ‡ฏ Benin
๐Ÿ‡ง๐Ÿ‡ฒ Bermuda
๐Ÿ‡ง๐Ÿ‡น Bhutan
๐Ÿ‡ง๐Ÿ‡ด Bolivia
๐Ÿ‡ง๐Ÿ‡ฆ Bosnia
๐Ÿ‡ง๐Ÿ‡ผ Botswana
๐Ÿ‡ง๐Ÿ‡ป Bouvet Island
๐Ÿ‡ฎ๐Ÿ‡ด British Indian Ocean Territory
๐Ÿ‡ง๐Ÿ‡ณ Brunei
๐Ÿ‡ง๐Ÿ‡ฌ Bulgaria
๐Ÿ‡ง๐Ÿ‡ซ Burkina Faso
๐Ÿ‡ง๐Ÿ‡ฎ Burundi
๐Ÿ‡ฐ๐Ÿ‡ญ Cambodia
๐Ÿ‡จ๐Ÿ‡ฒ Cameroon
๐Ÿ‡จ๐Ÿ‡ป Cape Verde
๐Ÿ‡ฐ๐Ÿ‡พ Cayman Islands
๐Ÿ‡จ๐Ÿ‡ซ Central African Republic
๐Ÿ‡น๐Ÿ‡ฉ Chad
๐Ÿ‡จ๐Ÿ‡ฑ Chile
๐Ÿ‡จ๐Ÿ‡ฝ Christmas Island
๐Ÿ‡จ๐Ÿ‡จ Cocos Islands
๐Ÿ‡จ๐Ÿ‡ด Colombia
๐Ÿ‡ฐ๐Ÿ‡ฒ Comoros
๐Ÿ‡จ๐Ÿ‡ฌ Congo
๐Ÿ‡จ๐Ÿ‡ฉ DR Congo
๐Ÿ‡จ๐Ÿ‡ฐ Cook Islands
๐Ÿ‡จ๐Ÿ‡ท Costa Rica
๐Ÿ‡ญ๐Ÿ‡ท Croatia
๐Ÿ‡จ๐Ÿ‡บ Cuba
๐Ÿ‡จ๐Ÿ‡ผ Curaรงao
๐Ÿ‡จ๐Ÿ‡พ Cyprus
๐Ÿ‡ฉ๐Ÿ‡ฐ Denmark
๐Ÿ‡ฉ๐Ÿ‡ฏ Djibouti
๐Ÿ‡ฉ๐Ÿ‡ฒ Dominica
๐Ÿ‡ฉ๐Ÿ‡ด Dominican Republic
๐Ÿ‡ช๐Ÿ‡จ Ecuador
๐Ÿ‡ช๐Ÿ‡ฌ Egypt
๐Ÿ‡ธ๐Ÿ‡ป El Salvador
๐Ÿ‡ฌ๐Ÿ‡ถ Equatorial Guinea
๐Ÿ‡ช๐Ÿ‡ท Eritrea
๐Ÿ‡ช๐Ÿ‡ช Estonia
๐Ÿ‡ช๐Ÿ‡น Ethiopia
๐Ÿ‡ซ๐Ÿ‡ฐ Falkland Islands
๐Ÿ‡ซ๐Ÿ‡ด Faroe Islands
๐Ÿ‡ซ๐Ÿ‡ฏ Fiji
๐Ÿ‡ฌ๐Ÿ‡ซ French Guiana
๐Ÿ‡น๐Ÿ‡ฑ East Timor
๐Ÿ‡น๐Ÿ‡ซ French Southern Territories
๐Ÿ‡ฌ๐Ÿ‡ฆ Gabon
๐Ÿ‡ฌ๐Ÿ‡ฒ Gambia
๐Ÿ‡ฌ๐Ÿ‡ช Georgia
๐Ÿ‡ฌ๐Ÿ‡ญ Ghana
๐Ÿ‡ฌ๐Ÿ‡ฎ Gibraltar
๐Ÿ‡ฌ๐Ÿ‡ฑ Greenland
๐Ÿ‡ฌ๐Ÿ‡ฉ Grenada
๐Ÿ‡ฌ๐Ÿ‡ต Guadeloupe
๐Ÿ‡ฌ๐Ÿ‡บ Guam
๐Ÿ‡ฌ๐Ÿ‡น Guatemala
๐Ÿ‡ฌ๐Ÿ‡ฌ Guernsey
๐Ÿ‡ฌ๐Ÿ‡ณ Guinea
๐Ÿ‡ฌ๐Ÿ‡ผ Guinea Bissau
๐Ÿ‡ฌ๐Ÿ‡พ Guyana
๐Ÿ‡ญ๐Ÿ‡น Haiti
๐Ÿ‡ญ๐Ÿ‡ฒ Heard Island and McDonald Islands
๐Ÿ‡ญ๐Ÿ‡ณ Honduras
๐Ÿ‡ญ๐Ÿ‡บ Hungary
๐Ÿ‡ฎ๐Ÿ‡ธ Iceland
๐Ÿ‡ฎ๐Ÿ‡ท Iran
๐Ÿ‡ฎ๐Ÿ‡ถ Iraq
๐Ÿ‡ฎ๐Ÿ‡ช Ireland
๐Ÿ‡ฎ๐Ÿ‡ฒ Isle of Man
๐Ÿ‡ฎ๐Ÿ‡น Italy
๐Ÿ‡จ๐Ÿ‡ฎ Cote d'Ivoire
๐Ÿ‡ฏ๐Ÿ‡ฒ Jamaica
๐Ÿ‡ฏ๐Ÿ‡ช Jersey
๐Ÿ‡ฏ๐Ÿ‡ด Jordan
๐Ÿ‡ฝ๐Ÿ‡ฐ Kosovo
๐Ÿ‡ฝ๐Ÿ‡ฐ Kosovo
๐Ÿ‡ฐ๐Ÿ‡ฟ Kazakhstan
๐Ÿ‡ฐ๐Ÿ‡ช Kenya
๐Ÿ‡ฐ๐Ÿ‡ฎ Kiribati
๐Ÿ‡ฐ๐Ÿ‡ต North Korea
๐Ÿ‡ฐ๐Ÿ‡ท South Korea
๐Ÿด Kurdistan
๐Ÿ‡ฐ๐Ÿ‡ผ Kuwait
๐Ÿ‡ฐ๐Ÿ‡ฌ Kyrgyzstan
๐Ÿ‡ฑ๐Ÿ‡ฆ Laos
๐Ÿ‡ฑ๐Ÿ‡ป Latvia
๐Ÿ‡ฑ๐Ÿ‡ง Lebanon
๐Ÿ‡ฑ๐Ÿ‡ธ Lesotho
๐Ÿ‡ฑ๐Ÿ‡ท Liberia
๐Ÿ‡ฑ๐Ÿ‡พ Libya
๐Ÿ‡ฑ๐Ÿ‡ฎ Liechtenstein
๐Ÿ‡ฑ๐Ÿ‡น Lithuania
๐Ÿ‡ฑ๐Ÿ‡บ Luxembourg
๐Ÿ‡ฒ๐Ÿ‡ด Macau
๐Ÿ‡ฒ๐Ÿ‡ฐ North Macedonia
๐Ÿ‡ฒ๐Ÿ‡ฌ Madagascar
๐Ÿ‡ฒ๐Ÿ‡ผ Malawi
๐Ÿ‡ฒ๐Ÿ‡พ Malaysia
๐Ÿ‡ฒ๐Ÿ‡ป Maldives
๐Ÿ‡ฒ๐Ÿ‡ฑ Mali
๐Ÿ‡ฒ๐Ÿ‡น Malta
๐Ÿ‡ฒ๐Ÿ‡ญ Marshall Islands
๐Ÿ‡ฒ๐Ÿ‡ถ Martinique
๐Ÿ‡ฒ๐Ÿ‡ท Mauritania
๐Ÿ‡ฒ๐Ÿ‡บ Mauritius
๐Ÿ‡พ๐Ÿ‡น Mayotte
๐Ÿ‡ซ๐Ÿ‡ฒ Micronesia
๐Ÿ‡ฒ๐Ÿ‡ฉ Moldova
๐Ÿ‡ฒ๐Ÿ‡จ Monaco
๐Ÿ‡ฒ๐Ÿ‡ณ Mongolia
๐Ÿ‡ฒ๐Ÿ‡ช Montenegro
๐Ÿ‡ฒ๐Ÿ‡ธ Montserrat
๐Ÿ‡ฒ๐Ÿ‡ฆ Morocco
๐Ÿ‡ฒ๐Ÿ‡ฟ Mozambique
๐Ÿ‡ฒ๐Ÿ‡ฒ Myanmar
๐Ÿ‡ณ๐Ÿ‡ฆ Namibia
๐Ÿ‡ณ๐Ÿ‡ท Nauru
๐Ÿ‡ณ๐Ÿ‡ต Nepal
๐Ÿ‡ง๐Ÿ‡ถ Caribbean Netherlands
๐Ÿ‡ณ๐Ÿ‡จ New Caledonia
๐Ÿ‡ณ๐Ÿ‡ฎ Nicaragua
๐Ÿ‡ณ๐Ÿ‡ช Niger
๐Ÿ‡ณ๐Ÿ‡ฌ Nigeria
๐Ÿ‡ณ๐Ÿ‡บ Niue
๐Ÿ‡ณ๐Ÿ‡ซ Norfolk Island
๐Ÿ‡ฒ๐Ÿ‡ต Northern Mariana Islands
๐Ÿ‡ณ๐Ÿ‡ด Norway
๐Ÿ‡ด๐Ÿ‡ฒ Oman
๐Ÿ‡ต๐Ÿ‡ธ Palestine
๐Ÿ‡ต๐Ÿ‡ฐ Pakistan
๐Ÿ‡ต๐Ÿ‡ผ Palau
๐Ÿ‡ต๐Ÿ‡ฆ Panama
๐Ÿ‡ต๐Ÿ‡ฌ Papua New Guinea
๐Ÿ‡ต๐Ÿ‡พ Paraguay
๐Ÿ‡ต๐Ÿ‡ช Peru
๐Ÿ‡ต๐Ÿ‡ญ Philippines
๐Ÿ‡ต๐Ÿ‡ณ Pitcairn Island
๐Ÿ‡ต๐Ÿ‡ซ Polynesia
๐Ÿ‡ต๐Ÿ‡ท Puerto Rico
๐Ÿ‡ถ๐Ÿ‡ฆ Qatar
๐Ÿ‡ท๐Ÿ‡ช Reunion
๐Ÿ‡ท๐Ÿ‡ด Romania
๐Ÿ‡ท๐Ÿ‡ผ Rwanda
๐Ÿ‡ธ๐Ÿ‡ญ Saint Helena
๐Ÿ‡ฐ๐Ÿ‡ณ Saint Kitts and Nevis
๐Ÿ‡ฑ๐Ÿ‡จ Saint Lucia
๐Ÿ‡ต๐Ÿ‡ฒ Saint Pierre and Miquelon
๐Ÿ‡ป๐Ÿ‡จ Saint Vincent and the Grenadines
๐Ÿ‡ผ๐Ÿ‡ธ Samoa
๐Ÿ‡ธ๐Ÿ‡ฒ San Marino
๐Ÿ‡ธ๐Ÿ‡น Sao Tome and Principe
๐Ÿ‡ธ๐Ÿ‡ฆ Saudi Arabia
๐Ÿ‡ธ๐Ÿ‡ณ Senegal
๐Ÿ‡ท๐Ÿ‡ธ Serbia
๐Ÿ‡ธ๐Ÿ‡จ Seychelles
๐Ÿ‡ธ๐Ÿ‡ฑ Sierra Leone
๐Ÿ‡ฒ๐Ÿ‡ซ Saint-Martin
๐Ÿ‡ธ๐Ÿ‡ฝ Sint Maarten
๐Ÿ‡ธ๐Ÿ‡ฐ Slovakia
๐Ÿ‡ธ๐Ÿ‡ฎ Slovenia
๐Ÿ‡ธ๐Ÿ‡ง Solomon Islands
๐Ÿ‡ธ๐Ÿ‡ด Somalia
๐Ÿ‡ฟ๐Ÿ‡ฆ South Africa
๐Ÿ‡ฌ๐Ÿ‡ธ South Georgia and the South Sandwich Islands
๐Ÿ‡ธ๐Ÿ‡ธ South Sudan
๐Ÿ‡ฑ๐Ÿ‡ฐ Sri Lanka
๐Ÿ‡ธ๐Ÿ‡ฉ Sudan
๐Ÿ‡ธ๐Ÿ‡ท Suriname
๐Ÿ‡ธ๐Ÿ‡ฏ Svalbard and Jan Mayen Islands
๐Ÿ‡ธ๐Ÿ‡ฟ Swaziland
๐Ÿ‡จ๐Ÿ‡ญ Switzerland
๐Ÿ‡ธ๐Ÿ‡พ Syria
๐Ÿ‡น๐Ÿ‡ผ Taiwan
๐Ÿ‡น๐Ÿ‡ฏ Tajikistan
๐Ÿ‡น๐Ÿ‡ฟ Tanzania
๐Ÿ‡น๐Ÿ‡ฌ Togo
๐Ÿ‡น๐Ÿ‡ฐ Tokelau
๐Ÿ‡น๐Ÿ‡ด Tonga
๐Ÿ‡น๐Ÿ‡น Trinidad and Tobago
๐Ÿ‡น๐Ÿ‡ณ Tunisia
๐Ÿ‡น๐Ÿ‡ท Turkey
๐Ÿ‡น๐Ÿ‡ฒ Turkmenistan
๐Ÿ‡น๐Ÿ‡จ Turks and Caicos Islands
๐Ÿ‡น๐Ÿ‡ป Tuvalu
๐Ÿ‡บ๐Ÿ‡ฌ Uganda
๐Ÿ‡บ๐Ÿ‡พ Uruguay
๐Ÿ Hawaii
๐Ÿ‡บ๐Ÿ‡ฒ USA Minor Outlying Islands
๐Ÿ‡บ๐Ÿ‡ฟ Uzbekistan
๐Ÿ‡ป๐Ÿ‡บ Vanuatu
๐Ÿ‡ป๐Ÿ‡ฆ Vatican City
๐Ÿ‡ป๐Ÿ‡ช Venezuela
๐Ÿ‡ป๐Ÿ‡ณ Vietnam
๐Ÿ‡ป๐Ÿ‡ฌ British Virgin Islands
๐Ÿ‡ป๐Ÿ‡ฎ United States Virgin Islands
๐Ÿ‡ผ๐Ÿ‡ซ Wallis and Futuna Islands
๐Ÿ‡ช๐Ÿ‡ญ Western Sahara
๐Ÿ‡พ๐Ÿ‡ช Yemen
๐Ÿ‡ฟ๐Ÿ‡ฒ Zambia
๐Ÿ‡ฟ๐Ÿ‡ผ Zimbabwe
Apply for this job
๐Ÿ’ต Salary
๐ŸŽช Benefits
๐Ÿง‘โ€๐Ÿ’ป Assembly Remove this filter
๐Ÿ‘ต Senior Remove this filter
๐ŸŽ’ Travel Remove this filter
โŒ Clear 2 results

IMVT Corporation


๐Ÿ‡บ๐Ÿ‡ธ United States
๐Ÿ’ฐ $45k - $95k*

Director

 

Design

 

System

Technical

Support

Financial

Leader

Strategy

Management

Operations

Executive

IMVT Corporation is hiring a
Remote Senior Director Clinical Supply Chain

\n\n\nOrganizational Overview:\n\nImmunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases.\n\nThe Role: \n\nThe Sr. Director, Clinical Supply Chain reports to the VP of CMC Operations & Global Supply Chain. The Sr, Director Clinical Supply Chain possesses a very good understanding of Clinical Supply Management and strategy, CMC regulatory, project management terminology and demonstrates effective communication skills.\n\nResponsible for leading and developing drug supply planning strategy and overall management of all aspects of drug supplies (IP) for global Phase I - III clinical studies as the leader across multiple IMVT studies. Communicate the supply strategies and supply needs back to CMC and develop am manufacturing strategy together with the technical team.\n\nImproves and/or stablishes operating policies and procedures and provide comprehensive coordination of complex global supply chain operations, inventories, materials, and procurement while ensuring compliance to regulations and guidelines.\n\nPerform financial planning for clinical supply management, including budgeting, forecasting, and strategic planning activities for clinical trials; and reconciliation of drug distribution invoices.  Mentors and manages direct reports supporting clinical trial supply managers and operations support.\n\nLead and manage clinical supply and logistics activities, including but not limited to demand forecasting and supply planning, IRT start-up and maintenance, label generation and approval, packaging and labeling operations, release and distribution, expiry extension, cold chain management, and inventory management. Provide leadership and oversight in monitoring inventory levels at depots and clinical sites through the life of a trial; take preventative actions to avoid potential supply issues. Provide Packaging and Labeling/distribution vendor oversight and relationship management.\n\nContribute and review the preparation of clinical protocols, clinical trial pharmacy manuals, packaging methods, batch records, drug labels, shipping documents, destruction certification, and coordinate the origination, proofing and translation of clinical study labels and generation.\n\nThe Sr. Director, Global supply chain, partners with the Clinical Operations group and CMC group to ensure continuous supply of Investigational Medicinal Product (IMP) for Immunovant trials. Support the development of packaging & labeling configuration, supports device assembly activities as they occur at packaging and labeling vendors, distribution and Interactive Response Technology (IRT) to supply study drug to global clinical trials using sound supply chain techniques.\n\nProvide leadership and management, and act as knowledgeable resource for establishment of effective collaboration with Clinical Operations for seamless delivery of IP to patients worldwide.\n\nProactively identifying potential issues, develop mitigating actions and notify Executive Management in a timely manner.\n\nProvide interpretation of regulatory guidance documents, regulations and directives and advising regarding their applicability and impact on internal labeling programs\n\n \n\nKey Responsibilities: \n\n\n* Interprets clinical synopsis and protocols and creates clinical forecasts.\n\n* Fundamental knowledge of inventory management and forecasting systems, IRT systems, and Clinical Trial Supply processes is required.\n\n* Oversee the execution of multiple clinical trials and proactively identifies potential supply chain issues, provides analysis and recommends solutions with the appropriate support from SMEs\n\n* Oversees and supports study close out activities including returned good reconciliation, inventory destruction Managing and executing overall Project Delivery through coordination of CMC efforts assigned to the entire project team (including but not limited to CMC, Supply Chain, Legal, Procurement, Regulatory, Clinical Development, and Clinical Operations).\n\n* Oversees the management of inventory and shipment logistics of all Immunovant product and potentially associated samples.\n\n* Ensures temperature excursion process is executed as required.\n\n* Liaison with Suppliers to manage relationships and drive triage level activities that require diligent focus with rapid start-up, resolution to issues, and respond to questions related to CMC projects.\n\n* Oversees and provides recommendations on packaging design based on study requirements, distribution and blinding strategy, oversees the execution of initial supplies and resupplies for all IMVT studies. Designs and implements strategic plans to supply study drug to complex global clinical trials using sound supply chain techniques.\n\n* Guides the IRT System Leads as necessary with regards to user requirement specifications management module(s) as applicable\n\n* Reviews IRT strategy across IMVT studies to ensure consistency where applicable\n\n* Leverages the inventory management capabilities of the IRT to appropriately manage studies\n\n\n\n\n \n\nRequirements:\n\n\n* Bachelor's degree in science, engineering, or another relevant field; advanced degree preferred\n\n* Experience with global pharmaceutical/biotech development and manufacturing operations for development-stage biologics, including upstream/downstream process development, formulation development (pre-filled syringe), analytical development, and device development\n\n* 10-plus years of relevant biopharmaceutical industry experience with 8 plus years in clinical supply management\n\n* Deep understanding of IRT systems\n\n* Extensive experience with clinical study design, execution of clinical trials and investigational supply management\n\n* Ability to manage diverse project activities with global contract CMOs and create a collaborative environment\n\n* Strong computer skills including MS Office\n\n* Hands-on, roll-up-your-sleeves approach with high sense of urgency and drive for results\n\n* Demonstrated communication, problem-solving, leadership, and negotiation/decision-making skills\n\n* Ability to think outside of the box and challenge the status quo\n\n* Natural entrepreneurial spirit with unrelenting dedication to delivering results\n\n* Desire to work in a fast-paced, innovative environment\n\n* Natural collaborator who enjoys working on a cross-functional team\n\n\n\n\n \n\nWork Environment:\n\n\n* Immunovantโ€™ s headquarters is located in New York City. The position is flexible for remote work.\n\n* Dynamic, interactive, fast-paced, and entrepreneurial environment\n\n* Domestic or international travel are required (10-20%)\n\n\n \n\n#Salary and compensation\n No salary data published by company so we estimated salary based on similar jobs related to Design and Senior jobs that are similar:\n\n $45,000 — $95,000/year\n
\n\n#Benefits\n ๐Ÿ’ฐ 401(k)\n\n๐ŸŒŽ Distributed team\n\nโฐ Async\n\n๐Ÿค“ Vision insurance\n\n๐Ÿฆท Dental insurance\n\n๐Ÿš‘ Medical insurance\n\n๐Ÿ– Unlimited vacation\n\n๐Ÿ– Paid time off\n\n๐Ÿ“† 4 day workweek\n\n๐Ÿ’ฐ 401k matching\n\n๐Ÿ” Company retreats\n\n๐Ÿฌ Coworking budget\n\n๐Ÿ“š Learning budget\n\n๐Ÿ’ช Free gym membership\n\n๐Ÿง˜ Mental wellness budget\n\n๐Ÿ–ฅ Home office budget\n\n๐Ÿฅง Pay in crypto\n\n๐Ÿฅธ Pseudonymous\n\n๐Ÿ’ฐ Profit sharing\n\n๐Ÿ’ฐ Equity compensation\n\nโฌœ๏ธ No whiteboard interview\n\n๐Ÿ‘€ No monitoring system\n\n๐Ÿšซ No politics at work\n\n๐ŸŽ… We hire old (and young)\n\n
\n\n#Location\nNew York City, New York, United States
Apply for this job

๐Ÿ‘‰ Please reference you found the job on Remote OK, this helps us get more companies to post here, thanks!

When applying for jobs, you should NEVER have to pay to apply. You should also NEVER have to pay to buy equipment which they then pay you back for later. Also never pay for trainings you have to do. Those are scams! NEVER PAY FOR ANYTHING! Posts that link to pages with "how to work online" are also scams. Don't use them or pay for them. Also always verify you're actually talking to the company in the job post and not an imposter. A good idea is to check the domain name for the site/email and see if it's the actual company's main domain name. Scams in remote work are rampant, be careful! Read more to avoid scams. When clicking on the button to apply above, you will leave Remote OK and go to the job application page for that company outside this site. Remote OK accepts no liability or responsibility as a consequence of any reliance upon information on there (external sites) or here.


IMVT Corporation


๐Ÿ‡บ๐Ÿ‡ธ United States
๐Ÿ’ฐ $50k - $80k*

Manager

 

Design

 

System

Technical

Testing

Quality Assurance

Management

Lead

Health

IMVT Corporation is hiring a
Remote Senior Manager CMC Quality Assurance

\nOrganizational Overview:\n\n \n\nImmunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases.\n\n \n\nThe Role:\n\n \n\nReporting to the Director, CMC Quality Assurance, this position is responsible for performing the primary Quality review of all post- manufacturing-related documentation for a large molecule - drug substance and sterile drug product. The CMC Quality Sr. Manager will be responsible for implementing processes for document receipt from contract manufacturing organization, batch packet assembly and transfer to internal Immunovant collaboration, quality review of manufacturing documents, and final submission into the electronic records retention system in compliance with global GxP regulations. This individual will have the unique opportunity to help design and shape IMVT Quality processes while collaborating with external contract organizations to establish compliant, efficient, measured, and integrated batch review processes at a rapidly growing biotechnology company.\n\n \n\nThe CMC Quality Sr. Manager assembles and performs a technical quality review of executed manufacturing and testing documents provided by the contract manufacturer and laboratories to ensure regulatory compliance with FDA, EMA, ROW and other applicable global health authority requirements that ultimately ensure patient safety. The CMC Quality Sr. Manager then will liaise with the Immunovant CMC Team and collaborate with the CMO Quality Unit to ensure prompt and thorough resolution to any open matters identified in the technical review.\n\n \n\nThis position will contribute to Immunovant's success by managing IMVT's batch compilation and review activities under the primary QA Leads' guidance while working closely with applicable functional areas across Immunovant and in partnership with CMO Quality.\n\n \n\nKey Responsibilities:\n\n \n\n\n* Provide strategic planning input and continual improvement measures focused on records processes or document structure, reporting/escalating critical quality issues\n\n* Conduct risk mitigation in the compilation of records and associated review activities, ensuring a compliant culture of quality through effective management with strong adherence to Immunovantโ€™s key value pillars\n\n* In close collaboration with the Quality and CMC, serve as a primary batch compilation lead and record point of contact for CMC and Quality, ensuring overall control and compliance, effectiveness, and efficiency of the Batch Compilation and Review Process\n\n* Partner with QA Document Control and Records Retention to define, develop, and document processes related to the assembly of the batch records in the eDMS system\n\n* Manage, maintain, and continuously improve the batch record review process as a facilitator for Quality Assurance in product teams\n\n* Identify, develop, and implement key performance metrics associated with the post-manufacture assembly of records, including CMO performance metrics relating to Quality and error reduction. Encourage an environment for โ€˜Quality Right First Timeโ€™ by building in efficiencies as necessary from a systematic and compliance perspective\n\n* Perform additional quality-related duties as assigned by Director, CMC Quality Assurance\n\n\n\n\nRequirements:\n\n \n\n\n* Bachelor (B.S.) or advanced degree in Biology, Chemistry, Immunology or related fields\n\n* A minimum of 5-8 years of GMP-regulated experience working within GMP Quality systems; in roles of increasing responsibility; substantial Drug Substance and Drug Product, clinical & commercial experience in GMP environment preferred\n\n* Experience interacting with FDA, EMA, and other global health authorities\n\n* Strong analytical and organizational skills, with attention to detail\n\n* Excellent written, verbal, listening, and interpersonal communication skills\n\n* Ability to professionally interface with all levels (e.g., senior-level executives, staff, colleagues, external partners, consultants)\n\n* Ability to manage multiple and sometimes conflicting priorities in a fast-paced and demanding environment\n\n* Ability to take initiative, prioritize and execute tasks with minimal direction or supervision, maintaining a high-level of confidentiality, integrity, and discretion at all times\n\n\n\n\n \n\nWork Environment\n\n \n\n\n* Remote location\n\n* Dynamic, interactive, fast-paced, and entrepreneurial environment\n\n* Domestic and international travel may be required (up to 10%) including required quarterly onsite meeting\n\n\n\n\n\n\n \n\n#Salary and compensation\n No salary data published by company so we estimated salary based on similar jobs related to Design, Testing and Senior jobs that are similar:\n\n $50,000 — $80,000/year\n
\n\n#Benefits\n ๐Ÿ’ฐ 401(k)\n\n๐ŸŒŽ Distributed team\n\nโฐ Async\n\n๐Ÿค“ Vision insurance\n\n๐Ÿฆท Dental insurance\n\n๐Ÿš‘ Medical insurance\n\n๐Ÿ– Unlimited vacation\n\n๐Ÿ– Paid time off\n\n๐Ÿ“† 4 day workweek\n\n๐Ÿ’ฐ 401k matching\n\n๐Ÿ” Company retreats\n\n๐Ÿฌ Coworking budget\n\n๐Ÿ“š Learning budget\n\n๐Ÿ’ช Free gym membership\n\n๐Ÿง˜ Mental wellness budget\n\n๐Ÿ–ฅ Home office budget\n\n๐Ÿฅง Pay in crypto\n\n๐Ÿฅธ Pseudonymous\n\n๐Ÿ’ฐ Profit sharing\n\n๐Ÿ’ฐ Equity compensation\n\nโฌœ๏ธ No whiteboard interview\n\n๐Ÿ‘€ No monitoring system\n\n๐Ÿšซ No politics at work\n\n๐ŸŽ… We hire old (and young)\n\n
\n\n#Location\nNew York City, New York, United States
Apply for this job

๐Ÿ‘‰ Please reference you found the job on Remote OK, this helps us get more companies to post here, thanks!

When applying for jobs, you should NEVER have to pay to apply. You should also NEVER have to pay to buy equipment which they then pay you back for later. Also never pay for trainings you have to do. Those are scams! NEVER PAY FOR ANYTHING! Posts that link to pages with "how to work online" are also scams. Don't use them or pay for them. Also always verify you're actually talking to the company in the job post and not an imposter. A good idea is to check the domain name for the site/email and see if it's the actual company's main domain name. Scams in remote work are rampant, be careful! Read more to avoid scams. When clicking on the button to apply above, you will leave Remote OK and go to the job application page for that company outside this site. Remote OK accepts no liability or responsibility as a consequence of any reliance upon information on there (external sites) or here.

358ms