Open Positions: Senior Director, Quality Assurance
Arvinas is a clinical-stage biopharmaceutical company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of therapies that degrade disease-causing proteins. Arvinas uses its proprietary PROTAC® Discovery Engine platform to engineer proteolysis targeting chimeras, or PROTAC® targeted protein degraders, that are designed to harness the body’s own natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. In addition to its robust preclinical pipeline of PROTAC® protein degraders against validated and “undruggable” targets, the company has two clinical-stage programs: ARV-110 for the treatment of men with metastatic castrate-resistant prostate cancer; and ARV-471 for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer. For more information, visit www.arvinas.com.
The Sr. Director, Quality Assurance is responsible for developing, maintaining and executing the requirements of the Arvinas Quality Systems as they pertain to the development, manufacturing, testing, release, shipment and/or distribution of active pharmaceutical ingredients (APIs), API and drug product intermediates, and drug products under development by the company. The position also provides Quality Assurance support for Clinical Operations and contributes to the development, performance monitoring and continuous improvement initiatives related to the company’s Quality Systems and their associated processes, policies. and procedures.
Under the direction of the Executive Director, Quality the position provides technical support and quality assurance oversight for the various contract manufacturing organizations (CMOs), contract research organizations (CROs), and service providers that perform process and clinical development, manufacturing, testing and GxP-related activities for the company.
The incumbent works directly with the Arvinas Quality team; Technical Operations; Clinical Operations; and the corresponding operations and quality assurance staff of the various CMOs, CROs and 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 the Executive Director, Quality and will be located at our headquarters in New Haven, CT.
Key responsibilities of this role include, but are not limited to:
Quality Assurance oversight of activities performed at suppliers (CMOs and GMP-related service providers) involving the development, manufacturing, testing, shipment and/or distribution of Arvinas products. These activities may include, but are not limited to:
- On-site or remote / virtual auditing 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 by the CMOs 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, intermediates, drug products) produced at Arvinas approved CMOs. 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 third parties, e.g., CMOs or service providers, or internal Arvinas sources. Interfaces with the CMOs or internal Technical Operations to resolve any concerns, gaps or discrepancies. Tracking of CMO deviations, CAPA and change requests per Arvinas Quality System requirements.
- Monitors the performance of third party suppliers (e.g., CMOs) with respect to deviations, CAPA, audit results, regulatory inspections and reports on metrics related to supplier performance.
Participates as a key member of the project teams to ensure timely execution of responsibilities to meet the established project timelines.
Quality Assurance oversight of activities performed at CROs and clinical vendors involved with the conduct of human clinical trials for Arvinas products. These activities may include, but are not limited to:
- On-site or remote / virtual auditing to support approval of new CROs; on-going qualification of existing CROs; or to investigate specific events involving GCP compliance (‘for cause’ audits). Review and follow-up on audit responses from these clinical service providers to ensure appropriate corrective and preventive actions (CAPA) are assigned and executed.
- Participates as a key member of the project teams to ensure timely execution of responsibilities to meet the established project timelines.
Provides Quality Assurance support and oversight for GxP-related computer systems, including Veeva Quality and Veeva RIM. Ensures proper implementation and maintenance of these systems to support the document management, training, and regulatory submissions functions.
Provides Quality Assurance support and leads regulatory inspection readiness initiatives for internal Arvinas products / systems and for Arvinas CMOs and CROs, as appropriate.
Supports implementation of the Arvinas Quality Systems Plan, including the development, review and/or approval of Arvinas Quality System policies, procedures, and work practices. Provides training to Arvinas colleagues and contractors on system requirements; conducts internal assessments and provides recommendations for improvements to existing quality system processes, policies, and procedures.
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 test methods.
- Experience with the application of phase-appropriate quality systems across the product development lifecycle (Phase 1 through commercial) preferred.
5+ years of Pharmaceutical Quality Assurance experience in management / oversight of third parties, e.g., CMOs, CROs, contract laboratories, clinical supply depots / distribution centers, including the conduct of qualification / GMP compliance audits.
Strong working knowledge in the application of the US and EU GMP regulations; ICH Guidances; and industry standard requirements for Pharmaceutical Quality Systems. 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 / discrepancies.
- Ability to prepare standard operating procedures, change requests 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 CMO performance metrics, coordination of inspection readiness activities.
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 QualityDocs experience strongly preferred.
B.S. in Chemistry, Pharmacy or a related scientific field. Advanced degree a plus, but not required.
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.