QA Operations, Senior Manager
Closing date 23rd January 2023
BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities. Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first‑to‑market or offer a substantial benefit over existing therapeutic options.
BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting‑edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.
Key Responsibilities
* 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 identify compliance risks and take 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.
Education, Skills and Experience
* Minimum of 8 years experience in 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.
* 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.
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