Arvinas is a clinical-stage biotechnology company leading the way in targeted protein degradation therapeutics. Arvinas is the first company to focus solely on protein degradation and its platform technology is the most advanced in the field. Since its founding in 2013, Arvinas’ PROTAC® Discovery Engine has been driving the most significant breakthroughs in the industry. Arvinas’ pipeline encompasses a range of validated and undruggable targets in oncology, immuno-oncology, and neuroscience. This includes three clinical-stage programs: bavdegalutamide (ARV-110) and ARV-766, which are being developed as potential treatments for men with late-line metastatic castrate-resistant prostate cancer, and ARV-471, which is being co-developed and commercialized by Arvinas and Pfizer as a potential treatment for patients with breast cancer.
#TeamArvinas is made up of more than 400 passionate and curious employees, whose diverse thoughts and perspectives are highly valued. Arvinas employees embrace the freedom to pursue innovation, think creatively, and give back. They are driven by the company’s values and mission – to improve the lives of patients with serious diseases by pioneering therapies created with our revolutionary PROTAC® protein degradation platform. We’re really excited about the work we’re doing inside and outside of Arvinas, and think you will be, too. But don’t just take our word for it – learn more about life at Arvinas and what employees have to say. For more information, please visit www.arvinas.com.
Position Summary
The Senior Director, Quality Assurance is responsible for leading the teams responsible for quality assurance activities related to process and analytical development, manufacturing, testing, release, storage, shipment and/or distribution of active pharmaceutical ingredients (APls), API and drug product intermediates, and drug products undergoing development by the company. Under the direction of the Executive Director, Quality the position provides leadership and management support for the quality assurance team members engaged in the oversight of the various contract development and manufacturing organizations (CDMOs) and GMP-related service providers that perform process and analytical development, manufacturing, testing, and clinical supplies warehousing and distribution for the company.
The position is also responsible for participation in the development, maintenance, and execution of the Arvinas Quality System requirements as they pertain to the function, including supplier management, risk management, batch release, deviation and CAPA management, and change control, as well as the related continuous improvement initiatives. The incumbent works directly with the Arvinas Quality team and cross-functionally with Technical Operations; Regulatory CMC; Project and Asset Team Management; Clinical Operations; and the corresponding technical and quality assurance staff of the various CDMOs and GMP-related service providers to ensure effective execution of the Arvinas Quality System requirements and compliance with the applicable GxP regulations/ guidelines and industry standards.
This position reports to Executive Director, Quality and can be located at our headquarters in New Haven, CT or work remotely from a location within the U.S.
Principal Responsibilities
Key responsibilities of this role include, but are not limited to:
- Leadership and direct 'hands on' support, when required, for the Quality Assurance (QA) teams providing QA oversight of suppliers (CDMOs and GMP-related service providers) contracted for the development, manufacturing, testing, shipment and/or distribution of Arvinas APls, API and drug product intermediates, and finished products. The scope of activities for these QA teams includes, but is not limited to:
- Supplier audits to support approval of new suppliers; on-going qualification of existing suppliers; or to investigate specific events involving GMP compliance or product quality ('for cause' audits). Review and follow-up on audit responses from suppliers to ensure appropriate corrective and preventive actions (CAPA) are assigned and executed.
- Review and approval of master batch records; product and material specifications; certificates of analysis; stability protocols and reports; validation protocols and reports; and other GMP-related documentation as developed I generated by the CDMOs and/or Arvinas Technical Operations.
- Review of executed batch records, in-process test results, deviations, and laboratory records, including raw data, as required to accept or reject product (API, API intermediates, drug products) manufactured by the Issuance of batch releases or rejections on behalf of the company, as appropriate.
- Review and/ or approval of deviations, CAPA, change requests and other related documentation as generated by suppliers, e.g., CDMOs or internal sources. Interfaces with the CDMOs and/or Arvinas Technical Operations to resolve any concerns, gaps, or discrepancies. Tracking of CMO deviations, CAPA and change requests per Arvinas Quality System requirements.
- Development of Technical/ Quality Agreements with key suppliers.
- Monitoring of supplier performance with respect to product quality, deviations, CAPA, audit results, regulatory inspections and reports on metrics related to supplier performance.
- Review of CMC regulatory submissions for accuracy, technical content, and data integrity elements.
- Participates as a key member of the project and asset teams to represent Quality Assurance and GxP regulatory requirements and ensure timely execution of responsibilities to meet the established project ti
- Supports implementation, maintenance, and execution of Arvinas Quality Systems, including the development, review and/or approval of the associated policies, procedures, and work practices. Provides recommendations for improvements to existing quality system processes and procedures.
- Participates as a member of the Arvinas Quality Board to report on supplier performance metrics/ KPls and GxP compliance risks and their management/mitigation.
Qualifications
- 15+ years of pharmaceutical quality assurance experience in support of product development, clinical and/or commercial manufacturing operations.
- Strong hands-on knowledge of API and drug product (oral solids) manufacturing processes and the associated analytical test methods and specifications.
- Experience with the application of phase-appropriate quality systems across the product development lifecycle (Phase 1 through commercial).
- 5+ years of management experience in building, developing, and leading Quality Assurance teams for delivering effective quality assurance and compliance results for companies reliant on third-party manufacturing and testing services.
- 5+ years of Pharmaceutical Quality Assurance experience in management/ oversight of contract operations, e.g., CDMOs, contract laboratories, clinical supply depots I distribution centers, including the conduct of qualification / GMP compliance audits.
- Strong working knowledge in the application of the US and EU GMP regulations; ICH Guidance’s; and industry standard requirements for Pharmaceutical Quality
- Experience in hosting regulatory inspections and in dealing with regulatory agencies throughout the drug product approval process.
- Strong communication skills (verbal/ written).
- Ability to effectively communicate with third party technical and quality assurance representatives to ensure Arvinas requirements are met and to resolve issues /
- Ability to prepare standard operating procedures and deviation / CAPA reports in accordance with Arvinas Quality System requirements.
- Oral and written presentation skills as needed to address colleagues at all levels of the organization, e.g., internal training presentations, presentation of COMO performance metrics, GxP risk management.
- Ability to work on multiple projects, manage competing priorities, and collaborate cross functionally in a dynamic fast-paced environment.
- Hands-on experience with the use of electronic document management and QMS systems; Veeva Quality Docs and Veeva QMS experience preferred.
Education
- B.S. in Chemistry, Pharmacy, or a related scientific field. Advanced degree a plus, but not required.
#LI-Remote
Arvinas is proud to offer a competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, and much more. To learn more about Arvinas, please visit www.arvinas.com
Arvinas is an Equal Opportunity Employer
