Quality Assurance Compliance Associate

Responsibilities:

• Support the maintenance and continual improvement of the site Quality Management System (QMS) in accordance with GMP, ISO 13485, and MDSAP requirements.
• Support external inspections by regulatory authorities and notified bodies, including coordination of audit hosting activities and preparation of adequate responses to audit findings.
• Maintain site inspection readiness by ensuring systems, documentation, and practices are audit-ready at all times.
• Manage the site self-inspection program, including developing annual plans, conducting inspections, and performing trend analysis.
• Follow up on site inspection commitments to ensure timely closure and adequacy of responses and corrective actions.
• Prepare and coordinate the Annual Product Quality Review (APQR) process, ensuring timely completion, data accuracy, and identification of improvement opportunities.
• Provide compliance oversight for site change management, including review and approval of change records and impact assessments.
• Monitor and trend quality system performance indicators (e.g., deviations, CAPAs, change controls) and identify areas for improvement.
• Conduct site-level gap assessments against corporate standards to ensure alignment with applicable regulatory requirements.
• Collaborate with cross-functional teams to ensure alignment with quality system requirements and to promote a strong culture of compliance.
• Support regulatory activities including document preparation, review of regulatory submissions, and coordination of responses to health authority queries.
• Support product registration, license maintenance, and timely communication of changes impacting regulatory filings.

Requirements:

• Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, Engineering, or a related field.
• 5 years of experience in a pharmaceutical or medical device manufacturing environment, with exposure to quality systems, compliance, and regulatory functions.
• Solid working knowledge of GMP, ISO 13485, and MDSAP standards.
• Proficient in Microsoft Office and quality management systems (TrackWise preferred).
• Hands-on experience supporting regulatory and notified body inspections.
• Preferably experienced in aseptic manufacturing environments.
• Strong attention to detail, with excellent organizational, communication, and problem-solving skills.