(CW) Technical Manager, QA (Contract)
BioMarin Pharmaceutical Inc.
Summary
Responsible for owning and continuously improving one or more global Supplier Quality Management (SQM) processes at BioMarin. As Business Process Owner (BPO), accountable for the overall efficiency and effectiveness of the Supplier Change Notification (SCN) process and Approved Supplier List (ASL) process. The Technical Manager will develop and execute associated processes, programs, and initiatives to ensure overall supplier performance for GMP Material Suppliers supporting Drug Substance and Drug Product manufacturing.
Job description
Summary Description
Responsible for owning and continuously improving one or more global Supplier Quality Management (SQM) processes at BioMarin. As Business Process Owner (BPO), accountable for the overall efficiency and effectiveness of the Supplier Change Notification (SCN) process and Approved Supplier List (ASL) process. The Technical Manager will develop and execute associated processes, programs, and initiatives to ensure overall supplier performance for GMP Material Suppliers supporting Drug Substance and Drug Product manufacturing.
Responsibilities
- Lead Quality-related reviews and cross-functional process teams, serving as a subject matter expert for Supplier Change Notifications.
- Lead all quality aspects for the management of BioMarin's Approved Supplier List.
- Establish process to monitor SCNs through key performance indicators (KPIs), trend analysis, and regular reviews, identifying and leading opportunities for improvement.
- Serve as the Business Process Owner for SCN and ASL processes, monitoring and maintaining process health, driving continuous improvement, and sustaining compliance with global health authority requirements.
- Review and approve Supplier Change Notifications in the QMS.
- Make decisions and act with authority to carry out actions as applicable.
- Collaborate with external and internal global and site stakeholders to identify, define, and implement opportunities for improved SCN process workflows.
- Develop, implement, and communicate quality policies and procedures to ensure consistency across the network.
- Support implementation of program enhancements to SCN and ASL processes.
- Provide SME support to site inspections, global inspections, and related observation responses.
Education
BA/BS in life sciences or related field.
Experience
- 6+ years of experience with Biotechnology, Pharmaceutical, Medical Device or other highly regulated industry.
- Knowledge and experience in GMP and GDP global regulations, principles, concepts, practices, and standards.
- Prior experience and knowledge in Supplier Quality, Compliance, or a combination such as Manufacturing, Quality, and Regulatory required. Knowledge in international regulatory landscape preferred.
- Demonstrated ability to work effectively in a matrix environment and drive results through influence as well as direct management.
- Organizational and management skills, with ability to effectively plan, schedule, execute, and track complex projects.
- Excellent interpersonal and communication skills and ability to influence diverse stakeholders and drive accountability and decision-making cross functionally.
- Ability to present data and defend approaches in front of management and inspectors.
- Ability to partner with other functional groups to achieve business objectives.
Requirements
- BA/BS in life sciences or related field
- 6+ years of experience with Biotechnology, Pharmaceutical, Medical Device or other highly regulated industry
- Knowledge and experience in GMP and GDP global regulations
- Prior experience in Supplier Quality, Compliance, or a combination such as Manufacturing, Quality, and Regulatory
- Demonstrated ability to work effectively in a matrix environment
- Organizational and management skills to plan, schedule, execute, and track complex projects
- Excellent interpersonal and communication skills
- Ability to present data and defend approaches in front of management and inspectors
Company overview
BioMarin Pharmaceutical Inc. is a leading global biotechnology company headquartered in San Rafael, California, specializing in the development and commercialization of innovative therapies for rare genetic diseases. Founded in 1997, the company has established itself as a pioneer in enzyme replacement therapies (ERTs) and genetic medicine, with a focus on addressing the root causes of serious, life-threatening conditions primarily affecting children. BioMarin's portfolio includes eight commercial therapies targeting various rare disorders, including mucopolysaccharidosis, phenylketonuria (PKU), achondroplasia, and hemophilia A. The company's groundbreaking work includes being the first to provide therapeutics for mucopolysaccharidosis type I and phenylketonuria. With approximately 3,000-3,500 employees worldwide and operations across North America, Europe, Asia Pacific, and South America, BioMarin maintains a strong commitment to transforming lives through genetic discovery. The company's research and development efforts continue to advance a robust pipeline of product candidates, applying a science-driven, patient-forward approach to address broader groups of genetic disorders.