Cerevel Therapeutics is hiring a Remote Manager GMP Vendor Quality Management
\nRole Summary:\n\n\nThe Manager, GMP Vendor Quality Management will maintain and utilize processes, quality systems, and tools to qualify and monitor outsourced GMP activities and GMP Vendors that are utilized in the manufacturing, packaging, labeling, testing, warehousing, and distribution of finished pharmaceutical products and investigational medicinal products. \n\n\n\nKey Responsibilities\n* Support and maintain the Cerevel GMP Vendor Management Program. This includes arranging contract auditor(s), assuring training documentation of the auditors is obtained and sustained to meet training requirements\n* This position is accountable for timely receipt of audit reports, organizing internal review or audit reports, issuance of audit reports to vendors, obtaining vendor responses, and closure of audits in a timely manner to support business needs and meet timing requirements of Cerevel procedures\n* Ensure assigned audits are 1) scheduled and conducted, 2) audit documentation is accurate and complete, 3) audit reports are sent to vendors, 4) acceptable responses are received from vendors, and 5) audits are closed out in Veeva as per respective procedures and timing\n* Ensure all assigned GMP vendors are appropriately qualified\n* Manage assigned Quality Agreements including their initiation, generation, and approval. Ensure that Quality Agreements are written, approved and in-place for external GMP vendors. Manage periodic reviews of assigned Quality Agreements\n* Support Sr. Manager, with execution of the GPQ Internal Audit Program\n* Ensure compliance with Cerevel requirements as well as applicable regulatory requirements\n* Provide necessary inputs to support reporting of key performance indicators, metrics, and compliance status of GMP Vendors to Global Quality senior management\n* Identify process improvement opportunities within the Vendor Management program to strengthen compliance and increase efficiency. Participate on continuous improvement projects related to the Vendor Management program\n* Support inspections and inspection readiness activities associated with the Vendor Management program\n* Additional Quality projects and responsibilities may be assigned based on business needs of a growing organization\n\n\n\nRequired Qualifications\n* At least 5 years of relevant Quality Assurance Vendor Management experience in a pharmaceutical industry\n* Experience in the qualification and management of vendors for oral solid dosage forms both Clinical and Commercial purposes. This includes CMOs/CDMOs, API manufacturers, primary/secondary packagers and labelers, contract laboratories, warehouses, and distributors\n* Experience supporting Health Authority Inspections\n* General understanding of how the Drug Development Process impacts vendor qualifications\n* Experience working in an electronic quality management system (Veeva or equivalent)\n* Highly motivated, flexible, and able to respond quickly to shifting priorities. Able to meet deadlines, with excellent organizational skills and keen attention to details\n* Strong verbal and written communication skills to effectively communicate with business functions and vendors\n* Ability to partner and build relationships with technical operation stakeholders and external vendors to enable high quality outcomes\n* Ability to travel up to 20% domestic travel, occasional international travel may be expected\n\n\n\nDesired Qualifications\n* ASQ Certified Quality Auditor certification, or equivalent\n* Prior experience qualifying vendors for sterile manufacturing a plus\n* Strong team player with a solutions-oriented, customer-service, and continuous improvement mind-set\n* Excellent interpersonal and problem-solving skills\n* Ability to coordinate timelines with internal customers and vendors\n\n\n\nEducation\n* Bachelorโs degree in life science or engineering field; significantly more working experience in the relevant areas may be required for candidates without a bachelorโs degree\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 Travel, API and Senior jobs that are similar:\n\n
$60,000 — $110,000/year\n
\n\n#Benefits\n
๐ฐ 401(k)\n\n๐ Distributed team\n\nโฐ Async\n\n๐ค Vision insurance\n\n๐ฆท Dental insurance\n\n๐ Medical insurance\n\n๐ Unlimited vacation\n\n๐ Paid time off\n\n๐ 4 day workweek\n\n๐ฐ 401k matching\n\n๐ Company retreats\n\n๐ฌ Coworking budget\n\n๐ Learning budget\n\n๐ช Free gym membership\n\n๐ง Mental wellness budget\n\n๐ฅ Home office budget\n\n๐ฅง Pay in crypto\n\n๐ฅธ Pseudonymous\n\n๐ฐ Profit sharing\n\n๐ฐ Equity compensation\n\nโฌ๏ธ No whiteboard interview\n\n๐ No monitoring system\n\n๐ซ No politics at work\n\n๐ We hire old (and young)\n\n
\n\n#Location\nBoston, MA (Remote)
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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.
Flashbots is hiring a Remote Senior Backend Engineer
About the Role\nFlashbots is on the hunt for seasoned, self-starter Backend Engineers who thrive in rapidly evolving environments, learn new technologies on the fly, and tackle complex problems with a builder mentality.\n\nResponsibilities\n\n* Contribute actively to the development of Flashbots' core products such as MEV-Boost, Mev-Share, the Flashbots Builder, Suave, and our future offerings.\n\n* Create and manage comprehensive technical documentation/diagrams for public use, fostering an understanding and accessibility of our products.\n\n* Develop and maintain public API services and user-friendly tools to support the Flashbots ecosystem, including searchers, integration partners, and end-users.\n\n* Implement robust tests to ensure the quality and stability of our offerings.\n\n* Engage positively with our community, addressing their technical issues and fostering a collaborative environment.\n\n\n\n\n\nQualifications\n\n* Proven experience working on production systems utilizing Golang or Rust.\n\n* Ability to contribute effectively in an asynchronous work environment, both as part of a team and working autonomously.\n\n* Adaptable, accountable, and solution-oriented, with a focus on delivering high-impact solutions.\n\n* T-Shaped skills, showcasing both depth of knowledge in a specific area and breadth of knowledge across multiple areas.\n\n\n\n\n\nNice-to-haves\n\n* Deep familiarity with the Ethereum ecosystem and MEV supply chain\n\n* Experience working across the Ethereum stack (e.g., working with Ethereum clients like Lighthouse, Prysm, Geth or Reth, smart contract programming, etc.)\n\n* Contributed to open-source projects\n\n\n\n\n\nAbout Flashbots\nFlashbots started in 2020 as a research and development organization formed to mitigate the negative externalities and existential risks posed by Maximal Extractable Value (MEV) to smart-contract blockchains, starting with Ethereum. We build products to maximally decentralize public blockchains, redistribute MEV, and empower users. We work closely with our community to ensure that our products have a positive impact, are secure, and can be used in production at scale.\n\nOur Impact\nSince the launch of Flashbots, we have had an immense impact on the world of cryptocurrency. The Flashbots Auction was launched in alpha in January 2021 and was quickly adopted by almost all Ethereum miners. Prior to Ethereum's Merge in 2022, Flashbots launched MEV-Boost, a temporary solution for out-of-protocol proposer-builder separation. MEV-Boost has since been adopted by over 90% of Ethereum validators and has significantly influenced the Ethereum PoS ecosystem. Now, Flashbots continues its journey with the introduction of MEV-Share as we continue our journey toward SUAVE.\n\nOur Research\nFlashbots Research is an independent arm of the organization that aims to become the hub of MEV research. In addition to conducting in-house analysis, Flashbots Research collaborates with external researchers at other institutions via an external grants program. Flashbots Research continues to publish seminal research on MEV, covering a wide range of topics including cross-chain MEV, EIP1559 and MEV, how ETH2 affects MEV, SGX and privacy, and more. For a full list of publications, visit writings.flashbots.net.\n\nWhy Flashbots?\n\n* Competitive salary\n\n* Significantly above market rate equity compensation package\n\n* Unlimited PTO with a high level of freedom and autonomy for your work\n\n* Attractive health cover package for US employees\n\n* Yearly budget for your individual learning and development goals\n\n* Work alongside the brightest minds in the crypto space\n\n* Help build the future of blockchain technology\n\n* Remote working - travel and work from anywhere in the world\n\n* Paid travel - team on-sites in different parts of the world, several times a year\n\n\n\nAt Flashbots, we are committed to building a diverse and inclusive team. We welcome applications from all qualified candidates regardless of their gender, race, ethnicity, religion, sexual orientation, age, or disability status. \n\n#Salary and compensation\n
No salary data published by company so we estimated salary based on similar jobs related to Crypto, Ethereum, API, Senior, Golang, Engineer and Backend jobs that are similar:\n\n
$60,000 — $110,000/year\n
\n\n#Benefits\n
๐ฐ 401(k)\n\n๐ Distributed team\n\nโฐ Async\n\n๐ค Vision insurance\n\n๐ฆท Dental insurance\n\n๐ Medical insurance\n\n๐ Unlimited vacation\n\n๐ Paid time off\n\n๐ 4 day workweek\n\n๐ฐ 401k matching\n\n๐ Company retreats\n\n๐ฌ Coworking budget\n\n๐ Learning budget\n\n๐ช Free gym membership\n\n๐ง Mental wellness budget\n\n๐ฅ Home office budget\n\n๐ฅง Pay in crypto\n\n๐ฅธ Pseudonymous\n\n๐ฐ Profit sharing\n\n๐ฐ Equity compensation\n\nโฌ๏ธ No whiteboard interview\n\n๐ No monitoring system\n\n๐ซ No politics at work\n\n๐ We hire old (and young)\n\n
\n\n#Location\nWorldwide
๐ 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.