Associate Director, Quality Assurance (GMP)

The Opportunity:

We are seeking a Quality professional to join our growing and evolving QA team at Relay Tx.  You will partner with GXP functional areas as well as your fellow QA colleagues to champion the quality systems at Relay Tx and help build and strengthen the relationships with our vendors.  This role is an opportunity to help the growing QA group implement, maintain, and continually improve the Relay QMS and apply it in a phase-appropriate manner.  This role will work on early and late-stage projects dealing with vendor interactions, lot disposition, and quality event resolution.

The successful candidate will be excited to “wear many hats” and thrive in a fast-paced fluid challenging environment as we do our part to move many programs forward to reach patients.

At Relay Tx, we take Quality seriously, but we don’t take ourselves too seriously.  You’ll have fun and be challenged in our collaborative and energetic environment where you’ll face new challenges every day.

Your Role:

• You will partner and guide your CMC counterparts to support external manufacturing of Intermediates, DS, and DP and perform batch disposition activities.
• You will be expected to collaborate and coach internal and external partners to navigate complex quality issues to ensure compliant solutions are explored and implemented.
• You will act as a SME/Partner within cross-functional teams as an experienced Quality technical resource.
• You will draft and enforce Quality Agreements between external vendors and Relay as needed.
• You will propose, assess and approve change controls and may serve as change owner on behalf of QA. You will also assist change control owners with ensuring compliant change procedures and processes are followed.
• You will conduct and assist in quality investigations/deviations, review corrective actions for adequacy and compliance, and ensure CAPA actions are identified and addressed.
• You will review and approve internal and external investigations/deviations, OOS, OOT, and other quality events as needed.
• You will be expected to identify and compile data into metrics for use in Management Reviews and Quality Improvement initiatives.
• Lead and support internal and external audit programs, and support inspection readiness.
• Provide all Relay teams support as QA SME customer support for any question they may have.
• Use your skills to identify gaps in current GMP procedures and policies and drive continuous improvement.
• Mentor, manage, and develop Quality personnel as applicable.
• Support the planning, design, and implementation of commercial readiness initiatives

Competencies for Success:

• You have a keen attention to detail but can shift focus based upon changing priorities.
• You are a team player, flexible and easy to work with in a fast and collaborative environment. You are solution-oriented with a customer service approach.
• You are willing to “roll up your sleeves” and engage in all aspects of the role, big and small.
• You are a “relationship” builder both internally and externally
• You have great communication and project management skills and can persuade busy colleagues to partner with you on projects to improve processes that deliver on the Relay Tx mission.

Your Background:

• Bachelor’s degree in a scientific field.
• Minimum of 10 years of Quality Assurance experience in the pharmaceutical or biotech industry, experience in small molecules is highly preferred. A combination of QA and relevant manufacturing experience may also be considered.
• Experienced and comfortable interfacing with and working with external vendors.
• Experience working with legacy and electronic quality systems.
• Experience working in a virtual environment.
• Strong knowledge of GXPs, with a focus on GMP and associated Analytical/QC testing.
• U.S. based person required, local to Boston preferred due to potential in-office requirements 

#JO1