Deciphera Pharmaceuticals
Pharma
Sr.Manager,GMPQualityAssurance
“Sr. Manager, GMP Quality Assurance at Deciphera Pharmaceuticals. Skills: GMP Quality Assurance, Quality Systems, Regulatory Compliance. Support Quality Systems. Improve Quality Systems”
Industry & Context.
Solve complex problems
Up to 20% travel
What They're Looking For.
Must Have
Bachelor’s degree in life sciences, 8+ years GMP Quality experience, Knowledge of global GMP regulations, Knowledge of quality systems, Proven ability to lead cross-functional initiatives, Proven ability to solve complex problems, Excellent communication skills, Excellent stakeholder management skills, Authorized to work in the U.S.
Nice to Have
Experience with eQMS, Experience with global markets
What You'll Do.
Support Quality Systems
Improve Quality Systems
Provide leadership to internal teams
Provide leadership to external partners
Ensure compliance with global GMP/GDP regulations
Ensure compliance with company standards
Lead batch release activities
Approve batch records
Review material disposition
Approve material disposition
Provide GMP oversight for manufacturing partners
Provide GMP oversight for distribution partners
Ensure compliance with FDA regulations
Ensure compliance with EMA regulations
Ensure compliance with ICH regulations
Manage investigations
Manage change controls
Support annual product reviews
Drive quality system improvements
Track key quality metrics
Partner with CMOs on validation
Partner with CMOs on tech transfer
Partner with CMOs on qualification
Partner with suppliers on validation
Partner with suppliers on tech transfer
Partner with suppliers on qualification
Mentor junior QA staff
Develop junior QA staff
How You'll Work.
Team & Collaboration
Internal teams; External partners; Cross-functional initiatives; CMOs; Suppliers
Communication Scope
Stakeholder management
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