This high-impact, permanent role as Quality Assurance Manager reports directly to the Global Quality Director.
About the Role
You will lead a quality team of four, including a QA/QC Tech Lead, two QC Lab Technicians, and a Quality Specialist. The key responsibilities include representing the company during audits and site visits, ensuring the Quality Management System (QMS) is effectively implemented and compliant with ISO 13485, ISO 9001, and EXCi PACT standards.
Key Responsibilities:
* Represent the company during audits and site visits.
* Ensure the Quality Management System (QMS) is effectively implemented and compliant with ISO 13485, ISO 9001, and EXCi PACT standards.
* Promote awareness of regulatory and customer requirements throughout the organization.
* Supervise and mentor a quality team to deliver on key initiatives and compliance goals.
* Oversee documentation, training, and strategies to uphold quality standards.
* Lead quality improvement projects and ensure timely task completion.
* Guide product development processes, from concept to commercialization.
* Prepare for and represent the company during regulatory audits and inspections.
* Manage Corrective and Preventive Actions (CAPAs) and Non-Conformance Reports (NCRs).
* Foster collaboration and effective communication across departments.
Requirements
The ideal candidate should have a Bachelor's degree (Level 8 or higher) in science, technology, engineering, or manufacturing, and 7+ years of experience in the pharmaceutical or a similar regulated industry, including leadership roles.
* Education: Bachelors degree (Level 8 or higher) in science, technology, engineering, or manufacturing.
* A masters degree or Ph D is advantageous but not required.
* Experience & Knowledge: 7+ years of experience in the pharmaceutical or a similar regulated industry, including leadership roles.
* Strong understanding of pharmaceutical/chemical manufacturing processes is a plus.
* Expertise in QMS management and regulatory compliance (e.g., ISO 13485, ISO 9001).
* Experience managing CAPAs, NCRs, change management, and customer complaints.
* Familiarity with medical device regulations, process validation, and equipment qualification.
* Proficiency in Six Sigma and Lean methodologies.
* Skills: Advanced problem-solving and decision-making abilities, strong leadership and project management experience, certified auditor qualifications (e.g., IRCA Lead Auditor), proven ability to contribute to cross-functional product development teams.