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 Raleigh site processes are controlled and regulatory-compliant. The CQA Manager supports audits directed by the Global audit function, maintains 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 audits; manage the vendor/supplier site list.
• Establish and manage internal audit schedule and completion of internal audits.
• Ensure continuous inspection readiness; lead during regulatory inspections and customer audits; act as back-up to 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.
• Ensure site and quality systems comply with regulatory changes.
• Provide regulatory expertise to technology transfer, as needed.
• Meet job objectives timely and escalate quality issues to the Site Head of Quality.
• Drive a culture of continuous improvement.
• Communicate professionally and manage multiple tasks under time constraints.
• Other activities as required.

Qualifications

• 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; VeevaVault preferred.
• In-depth knowledge of USP, CFR, ICH, ISO regulations, GMPs, and regulatory requirements (EU, Health Canada, TGA, ICH, PIC/S).
• Experience in a sterile manufacturing environment.
• Combination Product experience is 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 statistical methods.
• Experience implementing continuous improvement opportunities.
• Strong planning, organizational skills, and risk assessment abilities; ability to make sound judgments on risks.
• Excellent written and oral communication and problem-solving skills.
• Strong analytical skills with the ability to translate data trends into actionable strategies.
• Ability to work under pressure and meet deliverables; proficient with Microsoft Office and Visio.

Skills

• Quality system methodologies (FMEA, Pareto Analysis) and understanding of Six Sigma principles.

Additional Requirements

• Travel: less than 10%.