Quality Compliance Manager

About the role

The Quality Compliance Manager will lead and strengthen the site’s quality compliance programs, focusing on data integrity, investigations, product complaints, CAPA effectiveness, and inspection readiness. Working closely with cross‑functional teams and site leadership, you will ensure adherence to GMP, regulatory, and corporate requirements while fostering a culture of quality, integrity, and accountability.

Key responsibilities

• Partner with the Site Data Integrity Lead to promote good data management practices and a strong Data Integrity culture across GxP functions.
• Implement and maintain Data Integrity Governance programs, conduct periodic walkthroughs, identify ALCOA gaps and drive CAPA implementation.
• Lead investigations and quality compliance observations, manage product market complaints from receipt through root‑cause analysis and closure.
• Develop, review, and approve corrective and preventive action (CAPA) plans, monitor implementation timelines and verify effectiveness.
• Support annual product reviews, product recalls, field actions, and regulatory reporting as required.
• Present data integrity trends, metrics, risk assessments and compliance status updates to site leadership during Quality Management Review.
• Participate in site and global Data Integrity forums to share best practices and drive continuous improvement.

Required profile

• Proven experience in quality compliance, data integrity, or GMP environments, preferably within the pharmaceutical or medical device industry.
• Strong analytical mindset with ability to conduct scientific, risk‑based root‑cause investigations.
• Excellent collaboration skills to work with cross‑functional teams and senior leadership.
• Demonstrated ability to manage multiple investigations, complaints and CAPA projects simultaneously.
• Commitment to maintaining a high‑quality, patient‑focused culture.

Required skills

• In‑depth knowledge of ALCOA principles and GxP data integrity requirements.
• Experience with CAPA lifecycle management and effectiveness verification.
• Familiarity with regulatory expectations for product complaints, recalls and field actions.
• Ability to assess risk, develop metrics and present compliance status to leadership.