Sr. Manager, GMP Quality Assurance

Deciphera Pharmaceuticals • Waltham, MA

1d • $138,000 - $190,000 • Remote

About The Position

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.

Requirements

• Bachelor’s degree in life sciences, chemistry, or related field
• 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.

Nice To Haves

• Experience with eQMS (e.g., Veeva)
• Experience with global markets

Responsibilities

• Lead batch release activities, including review/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

• Competitive salary and annual bonus
• Comprehensive benefits package including medical, dental, vision insurance, 401(k) retirement plan with company match, and more
• Generous parental leave and family planning benefits
• Outstanding culture and opportunities for personal and professional growth

What This Job Offers

• Job Type: Full-time
• Career Level: Manager