Sr. Manager, GMP Quality Assurance
Job Description
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
Qualifications
Qualifications
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 Information
Deciphera 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.
EQUAL EMPLOYMENT OPPORTUNITY INFORMATION
Deciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements, we invite you complete the confidential survey at the end of this application. Providing this information is optional. It will not be accessible or used in the hiring process, and has no effect on your opportunity for employment. This information will also be treated confidentially. We are committed to make all hiring decisions and other employment decisions on a non-discriminatory basis.
Work Type: Full time
Job Location: Remote
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
Qualifications
Qualifications
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 Information
Deciphera 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.
EQUAL EMPLOYMENT OPPORTUNITY INFORMATION
Deciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements, we invite you complete the confidential survey at the end of this application. Providing this information is optional. It will not be accessible or used in the hiring process, and has no effect on your opportunity for employment. This information will also be treated confidentially. We are committed to make all hiring decisions and other employment decisions on a non-discriminatory basis.
Work Type: Full time
Job Location: Remote