Manager, Compliance Quality Assurance
Indivior
5 hours ago
On-site
Raleigh, NC
Corporate Functions
Responsibilities:
- Supervise, develop, manage, and train direct reports in Quality Systems and Lot Release; hire, coach, motivate; administer performance appraisals.
- Develop and maintain quality metrics/trend data; manage monthly/quarterly reviews.
- Manage the APQR process and deliver approved reports on time.
- Manage the Document Management System (SOPs, WIs, protocols) and periodic document reviews.
- Collaborate with Global Audit to build/manage annual supplier audit schedule and internal audit schedule.
- Maintain constant inspection readiness; lead “back room” during regulatory/customer audits and back up the inspection host.
- Issue batch records; ensure timely disposition of semi-finished drug product.
- Conduct root cause analysis and risk assessments.
- Review/approve non-conformances, CAPAs, and change controls; ensure compliance with regulatory requirement changes.
- Provide regulatory expertise for technology transfer; escalate quality issues; drive continuous improvement.
Qualifications:
- BS in a relevant scientific field (required).
- 10+ years pharmaceutical manufacturing experience (required).
- 5+ years progressive supervisory experience (required).
- Prior Quality System Management; VeevaVault preferred.
- Knowledge/experience with USP, CFR, ICH, ISO, current GMPs; EU/Health Canada/TGA/PIC/S knowledge preferred; sterile manufacturing required.
- Combination Product experience a plus; 21 CFR 210/211, Annex 1, cGMPs, GDPs preferred.
- Advanced data analysis/statistics; strong computer skills (Microsoft, Visio).
Benefits:
- Competitive PTO + company closure (Dec 24–Jan 1); bonus program; 401(k) with company match; profit-sharing; comprehensive medical/dental/vision/life/disability; HSA/FSA options; tuition reimbursement; adoption assistance.
- Supervise, develop, manage, and train direct reports in Quality Systems and Lot Release; hire, coach, motivate; administer performance appraisals.
- Develop and maintain quality metrics/trend data; manage monthly/quarterly reviews.
- Manage the APQR process and deliver approved reports on time.
- Manage the Document Management System (SOPs, WIs, protocols) and periodic document reviews.
- Collaborate with Global Audit to build/manage annual supplier audit schedule and internal audit schedule.
- Maintain constant inspection readiness; lead “back room” during regulatory/customer audits and back up the inspection host.
- Issue batch records; ensure timely disposition of semi-finished drug product.
- Conduct root cause analysis and risk assessments.
- Review/approve non-conformances, CAPAs, and change controls; ensure compliance with regulatory requirement changes.
- Provide regulatory expertise for technology transfer; escalate quality issues; drive continuous improvement.
Qualifications:
- BS in a relevant scientific field (required).
- 10+ years pharmaceutical manufacturing experience (required).
- 5+ years progressive supervisory experience (required).
- Prior Quality System Management; VeevaVault preferred.
- Knowledge/experience with USP, CFR, ICH, ISO, current GMPs; EU/Health Canada/TGA/PIC/S knowledge preferred; sterile manufacturing required.
- Combination Product experience a plus; 21 CFR 210/211, Annex 1, cGMPs, GDPs preferred.
- Advanced data analysis/statistics; strong computer skills (Microsoft, Visio).
Benefits:
- Competitive PTO + company closure (Dec 24–Jan 1); bonus program; 401(k) with company match; profit-sharing; comprehensive medical/dental/vision/life/disability; HSA/FSA options; tuition reimbursement; adoption assistance.