Senior Manager, GMP Quality Assurance

Deciphera Pharmaceuticals

Senior Manager, GMP Quality Assurance at Deciphera focusing on improving quality systems across products. Ensure compliance with global regulations while leading cross-functional teams and mentoring staff.

Posted 6/9/2026full-timeRemote • Massachusetts • 🇺🇸 United StatesSenior💰 $138,000 - $190,000 per yearWebsite

About the role

Key responsibilities & impact

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

Requirements

What you’ll need

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.
Experience with eQMS (e.g., Veeva) and global markets is a plus.
Must be authorized to work in the U.S.

Benefits

Comp & perks

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.

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

GMP Quality experiencebatch release activitiesmaterial dispositioninvestigationsdeviationsCAPAchange controlsquality system improvementsvalidationtech transfer

Soft Skills

leadershipproblem solvingcommunicationstakeholder managementmentoringteam development