Sr. Manager, Quality Validation
Indivior
4 hours ago
Remote friendly (Richmond, VA)
United States
Operations
Responsibilities:
- Develop, implement, and maintain validation policy and validation master plan.
- Lead validation activities for process validation, sterile manufacturing, oral solid dose, utilities, and computer systems.
- Oversee third-party CMO/CPO validation to ensure internal and regulatory compliance.
- Author, execute, review, and approve validation protocols, summary reports, and supporting documentation.
- Ensure validation meets Annex 1, FDA, EMA, and ICH requirements; maintain cGMP/global compliance.
- Support regulatory inspections/audits/due diligence as validation SME; partner with CMOs.
- Collaborate with Quality, Manufacturing, Regulatory, and IT teams; implement risk-based validation.
- Drive system/process improvements; ensure supplier validation documentation meets Indivior/Regulatory standards.
- Support URS development; lead/support FAT/SAT and related risk assessments.
- Lead/support IQ/OQ/PQ and Process Validation (PV); ensure annual validation/requalification.
- Support engineering studies and regulatory dossier updates related to validation.
- Develop training programs and perform other duties as assigned; ~10% US/international travel.
Qualifications / Required Skills:
- Bachelor’s degree in Engineering/Life Sciences (Master’s preferred).
- 10+ years pharma manufacturing/quality with 8+ years in validation, leading validation teams in regulated industries.
- Root cause analysis (RCA) experience; strong sterile/microbiology experience; knowledge of small molecules.
- Broad GMP and regulatory knowledge (EU, Health Canada, TGA, ICH, PIC/S, ISO).
- Leadership/communication; analytical/problem-solving; data trending.
- Strong technical/computer skills (e.g., Microsoft, SAP; and validation/equipment systems).
Benefits (if applicable): Competitive PTO (incl. Dec 24–Jan 1 closure), bonus, 401(k) with match, profit sharing, ESPP discount, comprehensive medical/dental/vision/life/disability, HSA/Flex options, adoption assistance, tuition reimbursement, concierge services, voluntary benefits, wellness perks.
- Develop, implement, and maintain validation policy and validation master plan.
- Lead validation activities for process validation, sterile manufacturing, oral solid dose, utilities, and computer systems.
- Oversee third-party CMO/CPO validation to ensure internal and regulatory compliance.
- Author, execute, review, and approve validation protocols, summary reports, and supporting documentation.
- Ensure validation meets Annex 1, FDA, EMA, and ICH requirements; maintain cGMP/global compliance.
- Support regulatory inspections/audits/due diligence as validation SME; partner with CMOs.
- Collaborate with Quality, Manufacturing, Regulatory, and IT teams; implement risk-based validation.
- Drive system/process improvements; ensure supplier validation documentation meets Indivior/Regulatory standards.
- Support URS development; lead/support FAT/SAT and related risk assessments.
- Lead/support IQ/OQ/PQ and Process Validation (PV); ensure annual validation/requalification.
- Support engineering studies and regulatory dossier updates related to validation.
- Develop training programs and perform other duties as assigned; ~10% US/international travel.
Qualifications / Required Skills:
- Bachelor’s degree in Engineering/Life Sciences (Master’s preferred).
- 10+ years pharma manufacturing/quality with 8+ years in validation, leading validation teams in regulated industries.
- Root cause analysis (RCA) experience; strong sterile/microbiology experience; knowledge of small molecules.
- Broad GMP and regulatory knowledge (EU, Health Canada, TGA, ICH, PIC/S, ISO).
- Leadership/communication; analytical/problem-solving; data trending.
- Strong technical/computer skills (e.g., Microsoft, SAP; and validation/equipment systems).
Benefits (if applicable): Competitive PTO (incl. Dec 24–Jan 1 closure), bonus, 401(k) with match, profit sharing, ESPP discount, comprehensive medical/dental/vision/life/disability, HSA/Flex options, adoption assistance, tuition reimbursement, concierge services, voluntary benefits, wellness perks.