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Executive Director, Quality

Company: Arvinas
Location: New Haven
Posted on: September 12, 2020

Job Description:

Open Positions : Senior/ Executive Director, Quality Arvinas is a clinical-stage biopharmaceutical company focused on developing new small molecules ? known as PROTAC® (PROteolysis Targeting Chimera) protein degraders ? aimed at degrading disease-causing cellular proteins via proteolysis. Based on innovative research conducted at Yale University by Dr. Craig Crews, Founder and Chief Scientific Advisor, the company is translating natural protein degradation approaches into novel drugs for the treatment of cancer and other diseases. Our proprietary PROTAC®-based drug paradigm induces protein degradation, rather than protein inhibition, using the ubiquitin proteasome system and offers the advantage of potentially targeting “undruggable” as well as “druggable” elements of the proteome. This greatly expands the ability to create drugs for many new, previously unapproachable targets. For more information, visit www.arvinas.com .

Position Summary

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.

Primary Responsibilities

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.

Qualifications

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.

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.

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Keywords: Arvinas, New Haven , Executive Director, Quality, Other , New Haven, Connecticut

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