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 .
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
This position is located at our corporate headquarters in New
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
Provide leadership to the Quality Systems and Quality Operations
organization that continually develops staff and functional
Oversee readiness plans, risk assesssments and preparations in
advance of GxP audits and inspections to ensure regulatory
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
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
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
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
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
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
Arvinas is an Equal Opportunity Employer.
Apply for this Position Your Name
Attach Cover Letter
Leading the way in targeted
protein degradation therapeutics.