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- 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
QualificationsQualifications- 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
Additional Details- Experience with eQMS (e.g., Veeva) and global markets is a plus
- Up to 20% travel may be required
- Must be authorized to work in the U.S.
Additional InformationDeciphera is committed to fair and equitable compensation practices. The base salary pay range for this role is $138,000 - $190,000. Actual compensation packages will depend on various factors, including, but not limited to depth of experience, education, skillset, overall performance and/or location.
Deciphera believes in providing a competitive compensation and benefits package to all employees. Our base salary is just one component of Deciphera's competitive total rewards strategy that also includes annual performance bonus, a long-term incentive plan, full range of benefits and other incentive compensation plans (if applicable)
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.
Apply Now: Join us in our mission to improve the lives of people with cancer. Apply today to become a part of our dynamic team!
