QA Operations, Senior Manager

BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines. The QA Operations, Senior Manager is responsible for Quality oversight of manufacturing operations and delivering product batch release commitments.

Requirements

• Recruitment, onboarding, management and development of team personnel
• Provide QA Support & Oversight to site manufacturing, material operations, engineering, MSAT/validation, IT and QC
• Ensure raw material, intermediate and Drug Substance /Drug Product is released in accordance with approved schedule and that all associated requirements are met
• Provide Quality input and guidance to ensure Lot Release of high quality products in compliance with current Good Manufacturing Practices (GMPs)
• Write, review and approve Standard Operating Procedures, Work Instructions, Quality Technical Agreements, Master Batch Records, Specifications and other GMP documentation
• Collaborate with inter-departmental and cross-functional teams to address issues and identify compliant resolutions
• Pro-actively identifies compliance risks and takes appropriate preventative actions
• Proactively identify potential issues, lead root cause analysis, make recommendations and aid in implementation for more complex issues
• Ensure high level of Quality / cGMP Awareness in partner Teams
• Collaborate with GEO and Novato Quality teams to ensure alignment of processes and multi-site resolution of complex issues
• Lead Area GMP Certification Activities
• Support Internal audit programme, permanent inspection readiness and Health Authority Inspection execution
• Support regulatory submissions, Annual Product Review and other regulatory commitments, as required
• Lead and support Quality and Site goals and initatives, as required

Benefits

• Comprehensive benefits package
• Opportunities for professional growth and development
• Inclusive and diverse work environment