Quality Assurance Manager

Job Summary

We are seeking an experienced and motivated Quality Assurance Manager to join our Quality Assurance team. This role is responsible for maintaining and enhancing the Quality Management System (QMS), ensuring compliance with global regulatory requirements, and driving continuous quality improvement across the organization.

The successful candidate will lead internal and external audit activities, support regulatory inspections, oversee quality systems and documentation, and collaborate with stakeholders across the business to promote a culture of quality and compliance.

Responsibilities

• Maintain and continuously improve the Quality Management System (QMS).
• Provide guidance and consultation to staff on quality and regulatory compliance matters.
• Plan, manage, conduct, and report internal audits, vendor audits, and GPvP audits.
• Facilitate regulatory inspections and accreditation audits.
• Manage customer audits, including pre-study and active study audits.
• Oversee the review, update, and maintenance of Standard Operating Procedures (SOPs).
• Monitor and communicate changes in local and global regulations relating to clinical research and quality activities.
• Maintain and manage the Corrective and Preventive Action (CAPA) system and database.
• Lead continuous improvement initiatives arising from audit findings, inspections, and quality reviews.
• Host and support ISO accreditation audits.
• Support quality-related activities, including Computer System Validation (CSV), vendor management, training, and quality reviews.
• Collaborate with cross-functional teams and subject matter experts to ensure compliance and quality excellence.
• Provide leadership, coaching, and support to Quality Assurance team members.
• Perform additional Quality Assurance responsibilities as assigned by the Head of Quality Assurance.

Education

• Bachelors degree in a relevant scientific, healthcare, or life sciences discipline.
• Masters degree preferred.
• Equivalent professional experience will also be considered.

Experience

• Minimum of 8 years experience in the pharmaceutical, biotechnology, CRO, or life sciences industry.
• Strong background in Quality Assurance and auditing.
• Experience managing internal, vendor, customer, and regulatory audits.
• Proven experience supporting regulatory inspections and quality systems.
• Previous people management or supervisory experience preferred.

Skills & Competencies

• Strong knowledge of Quality Management Systems (QMS) and applicable regulatory requirements.
• Excellent written and verbal communication skills in English.
• Advanced Microsoft Office and document management skills.
• Strong organizational and time management abilities.
• Ability to prioritize multiple tasks and meet deadlines.
• Excellent analytical, problem-solving, and decision-making skills.
• Strong stakeholder management and relationship-building skills.
• Strong leadership and supervisory capabilities.
• Ability to influence and gain credibility across all levels of the organization.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.