Manager, Compliance Quality Assurance

Manager, Compliance Quality Assurance

Indivior is a global pharmaceutical company dedicated to developing medicines to treat opioid use disorder (OUD) and providing evidence‑based treatment worldwide.

Location: Raleigh, NC

Reports To: Head, Site Quality, Raleigh

Title: Manager, Compliance Quality Assurance

The Compliance Quality Assurance (CQA) Manager leads and manages activities within the CQA team, ensuring site compliance, document control, APQR, quality technical agreements, site inspections, and bulk product dispositions. This role supports audits, maintains inspection readiness, and collaborates with the Head of Quality Systems & OPEX.

• Supervise, develop, manage, and train direct reports in Quality Systems and Lot Release.
• Effectively hire, coach, and motivate staff.
• Write and administer performance appraisals for department personnel.
• Develop, support, and sustain appropriate metrics, including processing and preparing trend data for presentation to management during monthly and quarterly reviews.
• Manage the APQR process and deliver approved reports on time per the approved schedule.
• Manage the Document Management System; create, review, and approve documents including SOPs, WIs and protocols. Manage periodic document reviews while meeting review dates.
• Collaborate with the Global audit function to develop the annual supplier audit schedule and manage completion of audits against the schedule. Manage the approved vendor/supplier site list for the site.
• Establish annually the internal audit schedule and manage completion of the internal audits against the schedule.
• Ensure the site maintains a constant state of inspection readiness. Lead the back room during regulatory inspections and customer audits. Act as backup to the inspection host.
• Issue batch records to operations in support of the schedule.
• Ensure timely disposition of semi‑finished Drug Product.
• Conduct root cause analysis and risk assessments.
• Review and approve non‑conformances, CAPAs, and change controls related to the area of responsibility.
• Ensure that the site and quality systems remain in compliance with changes to regulatory requirements.
• Provide regulatory expertise to the technology transfer process as needed.
• Proactively drive a culture of continuous improvement.
• Communicate effectively/efficiently with others in a professional manner.

• Bachelor of Science degree in a relevant scientific field.
• Minimum ten (10) years of experience in pharmaceutical manufacturing.
• Minimum five (5) years of progressive supervisory experience in pharmaceutical manufacturing.
• Prior Quality System Management experience; experience in Veeva Vault preferred.
• In‑depth knowledge of USP, CFR, ICH, ISO regulations and current GMPs, regulatory requirements related to international standards (EU, Health Canada, TGA, PIC/S).
• Experience in a sterile manufacturing environment required.
• Advanced computer skills with data analysis and statistical methods.
• Strong communication, analytical, and problem‑solving skills.
• Experience with continuous improvement opportunities.

• 3 weeks vacation plus floating holidays and sick leave.
• 401(k) and Profit Sharing Plan with company match up to 75% on the first 6% of contributions and profit‑sharing contribution equal to 4% of eligible pay.
• U.S. Employee Stock Purchase Plan – 15% discount.
• Comprehensive medical, dental, vision, life, and disability coverage.
• Health and dependent care flex spending options.
• Adoption assistance, tuition reimbursement, and coaching concierge services.
• Gym, fitness facility, and cell phone discounts.

Indivior is an equal opportunity employer. We encourage applications from all qualified individuals, including minorities, females, veterans, and people with disabilities.