Indivior · 1 month ago
Manager, Compliance Quality Assurance
Raleigh, NC
Full-time
Onsite
Mid, Senior Level, Lead/Staff
10+ years expIndivior is a global pharmaceutical company dedicated to helping patients with opioid use disorder. The Compliance Quality Assurance Manager is responsible for leading the CQA team, managing site quality events, ensuring compliance with regulatory requirements, and supporting audits and inspections.
Addiction TreatmentBiotechnologyCommunitiesHealth CareMedicalPharmaceuticalSocial
Responsibilities
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 back up to the inspection host
Issue batch records to operations in support of the schedule
Ensure timely disposition of semi-finished Drug Product
Ability to 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
Assure job objectives are met on a timely basis and escalate quality issues to the Site Head of Quality
Proactively drive a culture of continuous improvement
Communicate effectively/efficiently with others in a professional manner
Manage a wide variety of tasks under critical time constraints
Other activities as required
Qualification
Required
Bachelor of Science degree in a relevant scientific field required
Minimum ten (10) years of experience in pharmaceutical manufacturing required
Minimum five (5) years of progressive supervisory experience in pharmaceutical manufacturing required
Prior Quality System Management experience
Experience in a sterile manufacturing environment required
Advanced computer skills, knowledgeable of data analysis, and statistical methods
Successful implementation of continuous improvement opportunities
Results oriented, entrepreneurial, and self-motivated, with solid planning and organizational capabilities, a bias for action, and the capability to define and evaluate risks
Excellent communication both written and oral and problem-solving skills
Strong analytical skills with the ability to think strategically, develop tactics and measurable implementation plans and able to transform solid thinking into action
Proven ability to work under pressure without compromising deliverables
Ability to collect, understand and interpret data trends on the quality system performance
Strong computer skills including Microsoft platform and Visio
Preferred
Experience in VeevaVault preferred
In depth knowledge and experience with USP, CFR, ICH, and ISO regulations as well as current GMPs, regulatory requirements related to international standards including EU, Health Canada, TGA, ICH, PIC/S preferred
Combination Product experience a plus
Knowledge and understanding of regulatory requirements such as 21 CFR Part 210 and 211, Annex 1, cGMPs, and GDPs preferred
Knowledge of quality system methodologies, such as Failure Mode Effect Analysis, Pareto Analysis and understand Six Sigma principles
Benefits
3 weeks’ vacation plus floating holidays and sick leave
401(k) and Profit Sharing Plan- Company match of 75% on your first 6% of contributions discount and profit sharing contribution equal to 4% of your 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
Leverage Concierge/personal assistance services
Voluntary benefits including Legal, Pet Insurance and Auto/Home coverage
Gym, fitness facility and cell phone discounts
Company
Indivior
Indivior is a specialty pharmaceuticals business.
1001-5000 employees
H1B Sponsorship
Indivior has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (5)
2023 (5)
2022 (6)
2021 (4)
2020 (6)
Funding
Current Stage
Public CompanyTotal Funding
$400MKey Investors
Piper SandlerOaktree Capital Management
2024-11-05Post Ipo Debt· $400M
2024-07-12Post Ipo Equity
2014-12-23IPO
Leadership Team
Mark Crossley
Chief Executive Officer
Recent News
2026-01-09
2026-01-09
2025-12-24
Company data provided by crunchbase