Kerja Sepenuh Masa, Director – Manufacturing Compliance - Malaysia di Biocon Johor - Maukerja

Job Summary:

Lead manufacturing compliance and technical excellence across aseptic manufacturing operations, ensuring robust adherence to GMP, aseptic practices, regulatory requirements and site procedures. The role will provide strong technical and compliance leadership to manufacturing teams and drive a proactive culture of quality and right-first-time execution.

Job Description:

• Lead and strengthen manufacturing compliance across aseptic production operations, ensuring adherence to GMP, regulatory and internal quality standards.
• Provide strong technical guidance to Manufacturing teams on aseptic processing, contamination control, cleanroom practices, gowning, environmental monitoring and sterile manufacturing requirements.
• Drive compliance with SOPs, batch records, procedures and established manufacturing controls, ensuring consistent and right-first-time execution.
• Lead investigations into deviations, non-conformances, recurring compliance issues and process failures, ensuring robust root-cause analysis and effective CAPA.
• Partner closely with Quality Assurance, Engineering, Validation, MSAT and Manufacturing to resolve technical and compliance risks.
• Identify systemic compliance gaps and implement preventive actions, process improvements and sustainable controls.
• Support regulatory inspections and customer audits, including inspection readiness, response preparation and remediation of observations.
• Review and strengthen manufacturing practices related to aseptic interventions, personnel practices, equipment operation, cleaning, sterilization and contamination control.
• Drive compliance metrics and governance, identifying trends and proactively addressing potential risks.
• Build technical capability within Manufacturing through coaching, training and on-floor mentoring on GMP and aseptic practices.
• Ensure effective implementation and sustainability of quality and compliance improvement initiatives across the manufacturing site.

Candidate Profile:

• 15+ years of experience in pharmaceutical / Biopharmaceutical manufacturing, manufacturing compliance or technical operations.
• Strong experience in Aseptic / Sterile manufacturing operations is highly preferred.
• Strong technical knowledge of GMP, aseptic processing, contamination control and sterile manufacturing practices.
• Handson experience with deviations, CAPA, investigations, change controls, risk assessments and audit / inspection readiness.
• Strong understanding of cleanroom operations, environmental monitoring, gowning practices and aseptic interventions.
• Proven ability to work closely with Manufacturing and Quality teams and provide practical, shop-floor technical guidance.
• Strong analytical, problem-solving and stakeholder-management skills.
• Engineering / Pharmacy / Life Sciences or relevant technical qualification.
• Experience leading teams and influencing across a complex, highly regulated manufacturing environment.