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
Arvinas has an outstanding opportunity for a senior visionary leader to develop and execute our strategy for the Quality and EH&S functions in response to our continued company growth. The Vice President of Quality will provide strong leadership and excellent managerial skills in motivating, coaching, developing, and retaining a high-performance Quality and EH&S organization, as well as establishing and maintaining a quality-oriented culture.
S/he will communicate a vision for the Quality and EH&S functions, assess our current processes and systems, and leverage his/her demonstrated capability in scaling these functions to support the company growth while building a culture for excellence in quality and compliance.
This position reports to the Senior Vice President of Corporate Operations and is located at our corporate headquarters in New Haven, CT or can work in a hybrid arrangement.
Primary Responsibilities
- Establish and communicate a clear vision for Quality and GxP compliance at Arvinas and build a culture of Quality and GxP Compliance excellence.
- Drive informed decision-making and form strong collaborations cross-functionally.
- In partnership with CMC Regulatory, Technical Operations, Clinical Development, and Clinical Operations, create a strategic quality plan that addresses potential current and future risks and governs GxP-related organizational activities. Chairs the Arvinas Quality Board for the review of GxP-related risks and the action plans to mitigate those risks, as well as Management Review of quality systems performance.
- Provide leadership for the Quality Systems, Quality Operations, Clinical Quality Assurance, and EH&S organizations that continually develops staff and functional capabilities.
- Oversee inspection readiness plans, risk assessments, and activities in advance of GxP audits and inspections. Host for GxP regulatory inspections.
- Develop, implement, and ensure operational compliance with Arvinas’ Quality Systems processes and procedures. This includes all activities related to GxP compliance, including oversight of GxP Quality Systems, procedures, and practices; third-party manufacturing partners and the associated batch review and release activities; warehousing and distribution of clinical and commercial products; and the conduct of clinical trials through contract research organizations.
- Oversee activities relating to batch manufacturing and release, including approval of CDMos/CMOs, development and approval of Quality Agreements, review and approval of deviation investigations, change control documentation, validation protocols and reports, and management of material and product specifications.
- Review and approve Regulatory CMC submissions, including QC verification of submission drafts.
- Oversight of the internal audit program to identify compliance gaps and ensure sustainable GxP compliance.
- Responsible for developing and monitoring quality and compliance performance metrics, including the identification of continuous improvement opportunities to provide sustainable GxP compliance in a proactive Quality culture.
- Leadership and oversight for the EH&S function to ensure compliance with environmental, health and safety regulations and requirements; appropriate management of laboratory waste streams; training and support for the New Haven laboratory operations staff; and advancement of the sustainability program.
Functional Knowledge and Skills
- Experience leading and building a quality organization with technical depth in API and drug product manufacturing processes.
- Experience in scaling Quality functions to support the continued growth of the company through NDA approval and commercial launch.
- Broad range of quality experience inclusive of clinical and commercial manufacturing; application of phase-appropriate GMPs; Pharmaceutical Quality Systems; Clinical Quality Assurance; and Good Clinical Practices.
- Demonstrated Quality Leadership ability to operate strategically in the design and implementation of phase-appropriate quality systems and processes. .
- Fundamental understanding of the EH&S requirements for laboratory operations.
- Must have excellent organizational and time-management skills, including ability to adhere to schedules and deadlines.
- Extensive knowledge in 21CFR Parts 11, 210, and 211.
- Must have excellent oral, written and interpersonal skills with excellent attention to detail.
- Strong problem solving and analytical skills with demonstrated ability to be detail oriented.
Qualifications
- 15+ years of experience in building quality functions in small to medium sized and/or fast growth pharmaceutical companies.
- Demonstrated ability to build/scale a Quality organization and the required capabilities in a fast-paced growth
- Significant experience in building quality assurance capabilities for an externalized GMP environment, late-stage pipeline, and for supporting clinical and commercial operations.
Education
- Bachelor’s degree in life science required. Advanced degree in Chemistry or Biological Sciences preferred.
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
