Senior Director, Clinical Quality Assurance
Arvinas is a clinical-stage biopharmaceutical 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 two clinical-stage programs: ARV-110, which is being developed as a potential treatment for men with late-line metastatic castrate-resistant prostate cancer, and ARV-471, which is being developed as a potential treatment for patients with breast cancer.
#TeamArvinas is made up of more than 200 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 purpose – to improve the well-being of patients and families impacted by the devastating diseases Arvinas is working to treat. It’s an exciting time to be in drug development and it’s an exciting time to be at Arvinas. But don’t just take our word for it – here’s what Arvinas employees are saying. For more information, please visit www.arvinas.com.
The Senior Director, Clinical Quality Assurance (CQA) is responsible for developing, maintaining and executing the requirements of the Arvinas Quality Systems as they pertain to clinical development of drug products by the company. The position provides direct Quality Assurance support for the Clinical Development and Clinical Operations functions, including the areas of clinical pharmacology, toxicology, pharmacovigilance, clinical trial conduct (Phase 1 - 4) and clinical data management. The position also 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 quality assurance oversight and support for the various contract research organizations (CROs), clinical study sites and clinical service providers that perform GLP and GCP-related activities for the company.
The incumbent works directly with the Arvinas Quality Team, Clinical Development, Clinical Operations, Regulatory Affairs, and the corresponding quality assurance staff of the various CROs, clinical study sites, and clinical service providers to ensure effective execution of the Arvinas Quality System requirements and compliance with the applicable GLP and GCP regulations / guidelines and industry standards. He/she also interfaces with representatives of similar responsibility from business partners working in collaboration with Arvinas to ensure effective delivery of joint projects/objectives.
This position reports to the Executive Director, Quality and can be located at our headquarters in New Haven, CT, or in a hybrid or remote working environment.
Key responsibilities of this role include, but are not limited to:
- Quality Assurance oversight of activities performed at CROs and clinical service providers 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 and GLP 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.
- Provides Quality Assurance input / guidance regarding the handling of GLP/GCP compliance events that may occur to ensure these events are appropriately reported, investigated, and documented and that appropriate CAPA are identified and implemented, as appropriate.
- Provides inspection readiness support for key CROs and clinical study sites.
- Develops and approves Quality Agreements with key CROs and clinical service providers.
- Participates as a key member of internal and business partner project teams to ensure timely execution of responsibilities to meet the established project timelines.
- Serves as a standing member of the Arvinas Quality Board for the reporting of GLP and GCP compliance metrics, CRO audit performance, and recommendations to addresses areas of GLP and GCP compliance risk.
- Manages a team of Clinical QA professionals to ensure delivery of company and departmental objectives related to clinical development and GxP compliance. Manages contract support that may be required to support execution of CQA responsibilities.
- Provides support for regulatory inspection readiness initiatives, both internally and at Arvinas CROs and clinical sites, as appropriate.
- Performs verification reviews of clinical data and related information included with documents intended for subsequent regulatory submission or presentation at medical or investor conferences.
- Supports implementation of the Arvinas Quality Systems Plan, including the development, review and/or approval of Arvinas Quality System policies, procedures, and work practices associated with the GLP, GCP and GPvP requirements. Provides training to Arvinas colleagues and contractors on quality system requirements; conducts internal assessments and provides recommendations for improvements to existing quality system processes, policies, and procedures.
- Provides support for the implementation and qualification / validation of GCP/GLP-related computerized systems, as needed or requested.
- 15+ years of pharmaceutical clinical quality assurance experience in support of clinical development and clinical operations.
- Strong hands-on knowledge in the application and execution of GLP and GCP requirements.
- Experience with the application of phase-appropriate quality systems across the product development lifecycle (Phase 1 through commercial).
- Strong working knowledge in the application of the US and EU GCP guidelines, 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 business partners and third party clinical vendors and their quality assurance representatives to ensure Arvinas requirements are met and to resolve issues / discrepancies.
- Ability to prepare audit reports, quality agreements, standard operating procedures, and 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 CRO 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 Quality experience strongly preferred.
B.S. in a Healthcare-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