Senior Manager, GMP Quality Assurance

4w1 month ago

Deciphera Pharmaceuticals

Waltham, US · Full-time · $138,000 – $190,000

About this role

We are seeking a Senior Manager, GMP Quality Assurance to support and continuously improve Quality Systems across clinical and commercial products. This role provides leadership across internal teams and external partners to ensure compliance with global GMP/GDP regulations and company standards.

Key responsibilities include leading batch release activities, providing GMP oversight for manufacturing and distribution partners, and managing investigations, deviations, CAPA, and change controls. The role also ensures compliance with global regulations (FDA, EMA, ICH) and supports audits, inspections, and annual product reviews.

The Senior Manager drives quality system improvements and tracks key quality metrics while partnering with CMOs and suppliers on validation, tech transfer, and qualification activities. They also mentor and develop junior QA staff to strengthen the team.

Deciphera is committed to fair and equitable compensation practices and offers a competitive total rewards strategy. Join us in our mission to improve the lives of people with cancer and become part of a dynamic team with outstanding culture and opportunities for growth.

Requirements

8+ years of GMP Quality experience in pharma or biotech
Strong knowledge of global GMP regulations and quality systems
Proven ability to lead cross-functional initiatives and solve complex problems
Excellent communication and stakeholder management skills
Must be authorized to work in the U.S.
Experience with eQMS (e.g., Veeva) and global markets is a plus

Responsibilities

Lead batch release activities, including review and approval of batch records and material disposition
Provide GMP oversight for manufacturing and distribution partners (DS, DP, and supply chain)
Ensure compliance with global regulations (FDA, EMA, ICH)
Manage investigations, deviations, CAPA, and change controls
Support audits, inspections, and annual product reviews
Drive quality system improvements and track key quality metrics
Partner with CMOs and suppliers on validation, tech transfer, and qualification activities
Mentor and develop junior QA staff

Benefits

Annual performance bonus and long-term incentive plan
Comprehensive benefits package including medical, dental, vision insurance, 401(k) retirement plan with company match
Generous parental leave and family planning benefits
Outstanding culture and opportunities for personal and professional growth