Director – Manufacturing Compliance - Malaysia

Biocon; Johor; On-site; MYR 180,000 - 260,000; Full time

Job summary

Biocon in Malaysia’s Johor region seeks a senior leader to oversee manufacturing compliance and technical excellence across aseptic operations. You will drive GMP adherence, regulatory compliance and site quality initiatives, fostering a right-first-time culture on the manufacturing floor.

You will guide aseptic processing, contamination control and cleanroom practices, lead investigations, CAPA, and coordinate with QA, Engineering and Validation to mitigate risks and support regulatory

Qualifications

• 15+ years in pharma/biopharma manufacturing or quality operations.
• Strong aseptic/sterile manufacturing experience preferred.
• Deep GMP, aseptic processing, contamination control knowledge.
• Hands-on with deviations, CAPA, investigations, change controls, risk assessments and audits.
• Strong understanding of cleanroom operations and environmental monitoring.
• Proven ability to guide shop-floor technical teams and collaborate with QA.
• Excellent analytical, problem-solving and stakeholder management.
• Engineering / Pharmacy / Life Sciences or related technical qualification.
• Experience leading teams in regulated manufacturing.

Responsibilities

• Lead manufacturing compliance across aseptic production operations, ensuring GMP/regulatory and internal quality standards.
• Provide strong technical guidance on aseptic processing, contamination control, cleanroom practices and gowning.
• Drive SOPs, batch records, procedures and controls for right-first-time execution.
• Lead investigations into deviations, non-conformances and CAPA with robust root-cause analysis.
• Partner with QA, Engineering, Validation, MSAT and Manufacturing to resolve risks.
• Identify systemic compliance gaps and implement preventive actions.
• Support regulatory inspections and customer audits, including inspections readiness.
• Review and strengthen manufacturing practices related to aseptic interventions, equipment operation, cleaning and sterilization.
• Drive compliance metrics and governance, addressing trends and risks.
• Build technical capability through coaching and on-floor mentoring on GMP and aseptic practices.
• Ensure sustained quality/compliance initiatives across the site.

Skills

Aseptic / Sterile manufacturing

GMP compliance

CAPA & investigations

Deviations handling

Regulatory inspections

Quality systems

Leadership / team guidance

Environmental monitoring

Gowning & cleanroom practices

Risk assessment

Education

Engineering / Pharmacy / Life Sciences or relevant technical qualification

Job description

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.