Manager, Compliance Quality Assurance

Role Summary

The Compliance Quality Assurance (CQA) Manager is responsible for leading and managing activities within the CQA team. The scope includes managing site Quality events within the eQuality Systems, ensuring site Compliance, Document Control, Annual Product Quality Reviews (APQR), Quality Technical Agreements, site self-inspections, and Bulk Product dispositions. This role liaises with the Head of Quality Systems & OPEX to ensure processes at the Raleigh site are in a state of control and compliant with regulatory requirements. The CQA Manager supports audits directed by the Global audit function and maintains the site in a constant state of inspection readiness, and prepares/reviews site Quality Metrics for management review with recommendations for continuous improvement.

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 metrics including processing and presenting trend data for management reviews.
• Manage the APQR process and deliver approved reports on time per schedule.
• Manage the Document Management System; create, review, and approve documents including SOPs, WIs and protocols; manage periodic document reviews.
• Collaborate with Global audit to develop the annual supplier audit schedule and manage completion; manage the vendor/supplier site list.
• Establish and manage internal audit schedule and completion of internal audits.
• Maintain 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 site and quality systems comply with regulatory changes.
• Provide regulatory expertise to technology transfer process as needed.
• Ensure objectives are met timely; escalate quality issues to the Site Head of Quality.
• Drive a culture of continuous improvement.
• Communicate effectively and professionally; manage multiple tasks under time constraints.
• Other activities as required.

Qualifications

• Bachelor of Science in a relevant scientific field required.
• 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; VeevaVault preferred.
• In-depth knowledge of USP, CFR, ICH, ISO regulations, current GMPs; regulatory requirements for EU, Health Canada, TGA, ICH, PIC/S preferred.
• Experience in a sterile manufacturing environment required.
• Combination Product experience a plus.
• Knowledge of regulatory requirements such as 21 CFR Part 210 and 211, Annex 1, cGMPs, GDPs preferred.
• Advanced computer skills, data analysis, and statistics; experience with continuous improvement.
• Strong planning, organizational skills, and risk evaluation abilities; effective judgment on risks.
• Excellent written and verbal communication; problem-solving skills.
• Strong analytical skills; ability to turn data into actionable plans.
• Ability to work under pressure without compromising deliverables.
• Ability to collect and interpret data trends on quality system performance.
• Proficiency with Microsoft Office and Visio.

Skills

• Quality systems methodologies (FMEA, Pareto analysis, Six Sigma principles).

Education

• Bachelor of Science degree in a relevant scientific field.

Additional Requirements

• Travel: less than 10%.