Manager, Compliance Quality Assurance

Indivior • Raleigh, NC

87d

About The Position

The Compliance Quality Assurance (CQA) Manager is responsible for leading and managing activities within the CQA group. The scope of responsibilities includes Quality Systems, Compliance, Supplier Management, Document Control, Annual Product Quality Reviews (APQR), Quality Technical Agreements, Inspections, Validation and Final Product dispositions. This role will assure that the Quality Management System at the Raleigh site is in a state of control and compliant with regulatory requirements. The CQA Manager supports audits led by the Global audit function as well as any contracted audits and maintains the site in a constant state of inspection readiness. The CQA Manager will be expected to support the Head of site Quality in regulatory site inspections. Finally, the CQA Manager prepares/reviews Quality Metrics for management review and makes recommendations for continuous improvement.

Requirements

• Bachelor of Science degree in a relevant scientific field from an accredited university required.
• Minimum ten (10) years of experience in pharmaceutical manufacturing required.
• Minimum five (5) years of progressive supervisory experience required.
• Prior Quality System Management experience - including TrackWise and VeevaVault.
• 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.
• Experience in a sterile manufacturing environment required.
• Combination Product experience a plus.
• Knowledge and understanding of regulatory requirements such as 21 CFR Part 210 and 211, Annex 1, cGMPs, and GDPs.
• Advance 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.
• 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.
• Proven ability to work under pressure without compromising deliverables.
• Strong computer skills including Microsoft platform and Visio.

Nice To Haves

• Knowledge of quality system methodologies, such as Failure Mode Effect Analysis, Pareto Analysis and understand Six Sigma principles.

Responsibilities

• Supervise, develop, manage, and train direct reports in Compliance Quality Assurance.
• Develop, support, and sustain appropriate metrics including processing and preparing trend data for presentation to management during weekly, 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.
• Collaborate with the Global audit function to develop the annual supplier audit schedule and manage completion of audit against the schedule.
• Establish annually the internal audit schedule and manage completion of the internal audits against the schedule.
• Manage customer audits of the Raleigh site.
• Assure the site maintains a constant state of inspection readiness.
• Lead the back room during regulatory inspections and customer audits.
• Provide final disposition of Drug Product.
• Review and approve non-conformances, CAPAs, and change controls related to the area of responsibility.
• Assure 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.
• Manage a wide variety of tasks under critical time constraints.

Benefits

• 3 weeks' vacation plus floating holidays and sick leave, plus company closure from December 24th- January 1st.
• 401(k) and Profit Sharing Plan- Company match of 75% on your first 6% of contributions 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, Dependent Care and Limited Purpose Flex Spending and HSA options.
• Adoption assistance.
• Tuition reimbursement.
• Concierge/personal assistance services.
• Voluntary benefits including Legal, Pet Insurance and Critical Illness coverage.
• Gym, fitness facility and cell phone discounts.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree
• Number of Employees: 1,001-5,000 employees