Day One Biopharmaceuticals is hiring a
Remote Director GCP Quality Operations Lead
\nDIRECTOR, GCP QUALITY OPERATIONS LEAD \n \nDay One Biopharmaceuticals is an emerging, mission-driven, drug development company intentionally designed to identify, clinically evaluate, and successfully commercialize novel treatments for pediatric oncology patients, and ultimately to expand those benefits to patients of all ages. For more information, please visit our website at http://www.dayonebio.com.\n \nPOSITION SUMMARY: \n \nThe purpose of the Director, GCP Quality Operations Lead is to provide expertise and leadership in the areas of Good Clinical Practice Regulations (GCP), global regulations, and industry standard best practices. The Director, GCP Quality Operations Lead provides assurance of patient safety and data integrity and supports the Senior Director, GCP Quality Assurance in the execution of the quality framework of controls and oversight necessary to achieve compliance, inspection readiness, and continuous improvement. \n\n\n The scope of this position is global and across partnerships. This position serves as a designated point of contact for dedicated clinical trial projects and/or program teams related to respective clinical quality activities.\n \nThis position has the potential to be fully remote. Occasional travel will be required for in person meetings.\n \nESSENTIAL DUTIES AND RESPONSIBILITIES:\n \nOrganizational Relationships\n\n\nยท Reports to Senior Director, GCP Quality Assurance\nยท Member, Product Development Quality Council\nยท Partners with other Day One Biopharmaceuticals GMP Quality functional partners to assure consistent professional standards and harmonization\nยท Works with all relevant local and global Day One Biopharmaceutical staffs as requested\nยท Works with external contacts including Regulatory authorities (if necessary) as it applies to inspection activities, professional scientific groups, and consultants\nยท Works with appropriate functional areas to ensure appropriate and proportionate approach to quality and compliance issues and challenges\n \nResources Managed (budget and FTEs)\n\n\nN/A\n \nPrimary Responsibilities\n\n\nVendor Compliance\nยท Represents GCP/GLP/GVP Quality and Compliance interests in the GCP vendor and systems assessment process\nยท Provides guidance and subject matter expertise to business partners on training, quality and GCP compliance issues. \nยท Collaborate with the Director of GxP Audit Oversight with audit planning and initiates risk- based audit requests as needed.\nยท Liaises with the Director of GxP Audit and other key stakeholders, internally and externally, to lead, support, and monitor GCP vendor quality issue investigation, root cause analysis, corrective and preventive actions, and effectiveness verification checks through completion, as appropriate when reviewing quality of audit responses.\nยท Liase with stakeholders to ensure audit response actions are completed in a timely manner and evidence is meets quality requirements.\nยท Support the development of GCP documents and provide quality review and guidance where needed.\nยท Support as a member of the study management team and protocol deviation review.\nยท In partnership with procuring department lead (e.g. Clinical Operations, Pharmacovigilance and Patient Safety or Translational Sciences) and other stakeholders, assesses the need for quality-related Key Quality Indicator, implementation, and monitoring and supports identification and development of Key Performance Indicators\nยท Ensures quality activities are performed and documented in compliance with corporate policies, standards and all applicable global regulations with minimal supervisory oversight.\nยท Facilitates GCP quality issue management and assesses adequacy of proposed corrective and preventive actions (CAPA).\nยท Monitor for trends in GCP quality issues and propose remediation actions.\nยท Identifies and communicates to senior management the trends impacting clinical quality.\nยท Recommends changes to policies and procedures that improve quality and efficiency\nยท Manages development and implementation of Quality Agreements for Day One Biopharmaceuticals GCP vendors; ensures vendor fulfillment of the necessary requirements such as notifications, KPIs, and governance-related activities\nยท Supports ongoing risk identification, assessment, and mitigation as relates to the GCP vendorโs product or services\nยท Embraces latest technology to enhance visualizations of quality assurance metrics that facilitate better decision-making\nยท Manages GCP SOP quality review, identify gaps where a GCP SOP may be needed and conduct continuous improvement assessments of current GCP SOPs.\nยท Provides support and advice to organization in preparing for and through participation in GCP inspections.\n \nQuality Management\nยท Provides project and/or program level product development quality support in line with the execution of clinical research and scientific quality processes and compliance requirements, while ensuring patient safety and data and scientific integrity practices are followed and consistent with global policies and procedures.\nยท Supports the Director GxP Audit and Regulatory Intelligence in the development and maintenance of risk- based audit plan.\nยท Oversees the completion of resulting CAPAs identified in audit response actions.\nยท Supports the Senior Director in the definition of operational systems and plans for data collection, analysis, and action to achieve continuous improvement.\nยท Supports the Senior Director in the leadership of compliance analysis in complex research and scientific situations and supports the provisioning of recommendations to management and senior leaders in support of CAPAs, commitments, and inspections.\nยท Anchored in commitment to data and scientific integrity, the efficient and effective use of systems, and driving quality proactively.\nยท In conjunction with the Senior Director and Product Development and Clinical Development Leaders, the Director fosters compliance leadership across procedures and processes, employing quality oversight with reference to regulations as required.\nยท Shall effectively engage Day One Biopharmaceutical Functional teams, and support functional partner-aligned risk management strategies, plans, and processes.\nยท Shall support key partners in inspection readiness and inspection execution efforts and developing responses to regulator questions as required.\nยท Participates in projects outside of current responsibilities as needed to drive the organization forward to success.\nยท Contributes to determining solutions outside of current responsibilities as needed and manages day-to-day operational issues outside of current responsibilities as identified and assigned by the Senior Director, as needed.\nยท Responsible for clinical and regulatory intelligence knowledge transfer to functional teams and will maintain a current knowledge of industry quality trends as needed.\nยท Supports risk / impact assessments as needed for regulation updates or possible signals identified in audit metrics and quality issues.\nยท Assume responsibility for other activities/functions within GCP Quality as required and directed by the Senior Director, GCP Quality.\nยท \nQUALIFICATIONS \n \nยท Bachelorโs degree or equivalent experience in life sciences or quality required; Advanced academic qualification/degree preferred\nยท Equivalent relevant professional experience will be considered.\nยท 10+ years R&D experience or relevant experience in science and clinical research, ideally with supporting clinical/regulatory/medical affairs, quality management, translational sciences, clinical development; equivalent experience\nยท 10+ years of GLP/GCP/GVP quality risk management and/or quality assurance experience\nยท 5+ years of experience in working with and directly communicating with senior leaders with proven accountability, and demonstrated excellent interpersonal, communication, negotiation, influencing, and problem-solving capabilities\nยท 5 + yearsโ experience in working with and directly communicating with senior leaders with proven accountability, and demonstrated excellent interpersonal, communication, negotiation, influencing, and problem-solving capabilities\nยท Proven ability to function autonomously in a matrix model and in a team environment\nยท Proven ability to think creatively and to develop and execute strategic plans\nยท Travel Required: up to 25%\nยท Goes beyond the obvious and seeks novel approaches to complex issues\nยท Able to communicate complex information and analyses to a variety of scientific and non- scientific audiences in both verbal and written formats\nยท Works seamlessly with other cross-functional departments to include commercial organization and manufacturing organizations\n \nThe preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification.\n \nCOMPENSATION AND BENEFITS\n \nThe salary range for this position is $220,000 - $230,000. Day One considers a range of factors when determining base compensation. These considerations mean actual compensation will vary.\n \nPlease visit https://www.dayonebio.com/benefits to see our competitive benefits.\n \nDISCLAIMER\n \nDay One Biopharmaceuticals is committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants without regard to race, color, religion, sex, pregnancy (including childbirth and related medical conditions), national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information (including characteristics and testing), military and veteran status, and any other characteristic protected by applicable law.\n \nEmployment is conditioned upon full vaccination from the COVID-19 virus, including submission of documented proof thereof, as of the start date. Day One Biopharmaceuticals will comply with applicable law regarding the reasonable accommodation of individuals who are not vaccinated because of a disability and/or a sincerely held religious belief.\n \nRecruitment & Staffing Agencies: Day One Biopharmaceuticals does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Day One Biopharmaceuticals or its employees is strictly prohibited unless contacted directly by Day One Biopharmaceuticalโs internal HR team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Day One Biopharmaceuticals, and Day One Biopharmaceuticals will not owe any referral or other fees with respect thereto.\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 Senior and Non Tech jobs that are similar:\n\n
$50,000 — $86,250/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\nRemote - Work From Home anywhere in US