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Sr. Manager, GMP Quality Assurance
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Deciphera Pharmaceuticals
Waltham, MA (In Person)
$164,000 Salary, Full-Time
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Job Description
Job DescriptionWe 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 ResponsibilitiesLead batch release activities, including review/approval of batch records and material dispositionProvide 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 controlsSupport audits, inspections, and annual product reviewsDrive quality system improvements and track key quality metricsPartner with CMOs and suppliers on validation, tech transfer, and qualification activitiesMentor and develop junior QA staffQualificationsQualificationsBachelor's degree in life sciences, chemistry, or related field8+ years of GMP Quality experience in pharma or biotechStrong knowledge of global GMP regulations and quality systemsProven ability to lead cross-functional initiatives and solve complex problemsExcellent communication and stakeholder management skillsAdditional DetailsExperience with eQMS (e.g., Veeva) and global markets is a plusUp to 20% travel may be requiredMust 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)
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.
Key ResponsibilitiesLead batch release activities, including review/approval of batch records and material dispositionProvide 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 controlsSupport audits, inspections, and annual product reviewsDrive quality system improvements and track key quality metricsPartner with CMOs and suppliers on validation, tech transfer, and qualification activitiesMentor and develop junior QA staffQualificationsQualificationsBachelor's degree in life sciences, chemistry, or related field8+ years of GMP Quality experience in pharma or biotechStrong knowledge of global GMP regulations and quality systemsProven ability to lead cross-functional initiatives and solve complex problemsExcellent communication and stakeholder management skillsAdditional DetailsExperience with eQMS (e.g., Veeva) and global markets is a plusUp to 20% travel may be requiredMust 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.