MSc with 3 years’ QM experience in similar industry. GMP, GLP and ISO 13485 experience beneficial.

Location:Cape Town
Description:A leading Biotechnology Company is looking for a Quality Manager to join their team. Responsibilities will include but is not limited to: Department Manager for Quality Assurance and Quality Control functions; ensure that the appropriate Quality standards are defined, that a formal Quality Management System is planned, established, managed and improved as required, and that it integrates with other management systems (such as People, Finance and EHS); act as advisor to Executive Committee and Leadership Team; act as the Management Representative for Quality as defined in ISO 13485; facilitate and manage steering committees and forums for the organization; plan and budget for departmental needs; define and manage areas of competence that require development or staff; oversee process implementation; escalate high-risk Quality issues to the Leadership Team; oversee delivery of Quality Assurance services (e.g. document, record, change and deviation control, nonconformance investigations and corrective action management, management review (coordination), control of nonconforming product, auditing, supplier risk management, quality risk management, batch release); oversee delivery of Quality Control services (e.g. sampling, testing, internal release, trending, status labelling, reference standards, testing, reporting, laboratory investigations and stability studies); planning, monitoring and reporting at strategic and operational levels.
Key Requirements:MSc with at least 3 years’ experience as Quality Manager in a similar industry. Pharmaceutical and regulatory background as well as GMP, GLP and ISO 13485 experience will be beneficial.
Additional Requirements:Strong leadership and management skills. Strong cross functional skills. Excellent communication and negotiation skills. Organizational and administrative skills. Excellent English verbal and written communication skills.
*Only candidates that meet all the requirements should apply
**Please quote “Quality Manager (W902)” in the subject line
***Only candidates that are shortlisted will be contacted

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