In this role, the Senior/Executive Director, Quality is accountable to the creation, implementation and all operational compliance aspects of Arvinas' Quality System. This includes, but is not limited to, all activities related to GxP compliance, including oversight of conduct of GxP procedures and practices, efficient cGMP and GDP activities for clinical products and ancillary materials, manufacturing partners, and compliance of clinical conduct.
This position is located at our corporate headquarters in New Haven, CT.
- In partnership with CMC, Technical Operations, Research and Clinical Development, create a strategic quality plan that both addresses potential current and future risks and governs organizational activities.
- Provide leadership to the Quality Systems and Quality Operations organization that continually develops staff and functional capabilities.
- Oversee readiness plans, risk assesssments and preparations in advance of GxP audits and inspections to ensure regulatory compliance.
- Design and develop Standard Operating Procedures and guidelines for quality department.
- Develop and manage department staff to ensure they are adhering to the SOPs' guidelines and policies.
- Oversee activities relating to batch records release, product investigations, quality investigations and annual product reviews.
- Manage the gap assessments of GMP operations and supervise the final disposition of products manufactured in accordance with GMP practices and health authority regulations.
- Create procedures and strategic plan that incorporates internal and external audits to ensure continual compliance.Manage the quality oversight and manufacturing of product distribution for CMO's.
- Oversee the approval process of all processes, change control documents and validations.
- Work in collaboration of Clinical, Regulatory and Manufacturing to adhere to relevant GxP requirements.
- Responsible for developing and monitoring metrics that demonstrate appropriate adherence and compliance in driving a Quality culture.
Functional Knowledge and Skills
- Demonstrated ability within QA and QC to operate strategically in the design of functional programs to the execution and implementation of best practices and policies.
- Extensive knowledge in Quality Assurance and Quality Control measures and best GMP compliance and regulations.
- Demonstrated understanding of drug substance and drug product manufacturing processes.
- Clear understanding of GCP requirements.
- Must have excellent organizational and time-management skills including ability to adhere to schedules and deadlines.
- Extensive knowledge in 21CFR parts 11, 210, 211 and 820.
- 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.
- 12+ years of experience in Quality Assurance and/or Quality control.
- Bachelor's degree in life science required. Advanced degree in Chemistry or Biological Sciences is strongly preferred.