QA Operations, Senior Manager

Closing date: 23 January 2023

Hybrid role: Minimum 3 days per week onsite

The QA Manager, Senior Manager for Operations is responsible for Quality oversight of manufacturing operations at the Shanbally Site and for delivering product batch release commitments in conjunction with the QP.

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• Recruitment, onboarding, management and development of team personnel. Deployment of team across multi-functional process teams.
  
• 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- collaborate with QP
  
• Provide Quality input and guidance to ensure Lot Release of high quality products in compliance with current Good Manufacturing Practices (GMPs).
  
• Provide Quality direction and oversight of technical transfer, routine operations, and continuous improvement within operations.
  
• Provide Quality input to Change Controls, Protocols and Reports ensuring scope of records are clear and implementation activities are robust and timely.
  
• Review and approval of Deviations and associated CAPAs for closure ensuring compliance with appropriate documentation, whilst ensuring that CAPA actions address root cause and implementation plan dates are achievable.
  
• Write, review and approve Standard Operating Procedures, Work Instructions, Quality Technical Agreements, Master Batch Records, Specifications and other GMP documentation in accordance with BioMarin Policies.
  
• Collaborate with inter-departmental and cross-functional teams to address issues and identify compliant resolutions to ensure manufacturing/release schedules are maintained.
  
• 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 initiatives, as required
  
• Other duties as assigned.
  

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• Minimum of 8 years experience in the pharmaceutical industry.
  
• At least 5 years experience in a Quality leadership role.
  
• Proven track record of leading and developing high‑performing teams.
  
• Proven compliance and regulatory capability. xcfaprz
  
• QP eligibility is an advantage.
  

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.