(CW) Technical Manager, QA (Contract) at BioMarin… · Novato

Who We Are

BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions.

Guided by our purpose to develop medicines that make a profound impact on people’s lives, our global teams have delivered a portfolio of therapies since our founding in 1997. Our revolutionary treatments for conditions like achondroplasia (the most common form of dwarfism), PKU (phenylketonuria), CLN2, a form of Batten disease, and a number of forms of MPS (mucopolysaccharidosis) offer new possibilities for patients and families who previously had few, if any, available options. More recently, with the close of the Amicus acquisition, our portfolio has expanded to include therapies for Fabry disease and Pompe disease, expanding our ability to reach more people living with rare genetic conditions.

Our success comes from our unwavering commitment to excellence, our deep understanding of patient needs, our scientific expertise, and our world-class manufacturing capabilities. At the heart of BioMarin is a dedicated team of the brightest minds in the industry working together to deliver innovative therapies to patients and families around the world.

About Technical Operations

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.

Contract -Hybrid Role - 3 days in the office in Novato, CA

SUMMARY DESCRIPTION:

Responsible for owning and continuously improving one or more global Supplier Quality Management (SQM) processes at BioMarin. As Business Process Owner (BPO), they are accountable for the overall efficiency/effectiveness of the Supplier Change Notification (SCN) process and Approved Supplier List (ASL) process at BioMarin. The Technical Manager will be accountable for developing, executing associated processes, programs, and initiatives to ensure overall supplier performance for GMP Material Suppliers to support BioMarin’s Drug Substance and Drug Product manufacturing. They will contribute to the implementation of a risk-based approach to the management of SCNs and lead efforts for periodic review and updates. They will establish the governance structure and controls to ensure the SCN and ASL processes are consistently applied across the supply base, ensure the health of the SQM process is continuously evaluated, and drive continuous improvement. Cross functional collaboration with external and internal partners and stakeholders across different sites and functions is key for success in this role. This includes collaboration with Supply Chain, Compliance, Global Sourcing and Procurement (GSP), Global Manufacturing Sciences and Technology (GMSAT), and other site functions. This position requires knowledge and experience with supplier management processes. The person must possess technical expertise and business acumen in the areas of responsibility.

RESPONSIBILITIES ▪ Lead Quality-related reviews, 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 process(es), proactively monitoring and maintaining the health of the process and subprocesses, driving continuous improvement efforts, and sustaining compliance with current and evolving global health authority requirements and regulations. ▪ Review and approve Supplier Change Notifications in the QMS. ▪ Make decisions and act with authority to carry out actions as applicable. ▪ Collaborate with external/internal global and site stakeholders to identify, define, and implement opportunities for improved SCN process workflows, while aligning the process with organizational goals and strategies. Promote knowledge sharing and the best practices. ▪ Develop, implement, and communicate quality policies and procedures to ensure consistency across the network and alignment with global processes. ▪ 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 of experience 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 group to achieve business objectives.

Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

Equal Opportunity Employer/Veterans/Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Ireland Safety Responsibility Support the organisation’s commitment to environmental protection, injury prevention, and continual improvement of EHS management systems. Actively contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents and participating in EHS initiatives and training. Ireland Safety Responsibility Support the organisation’s commitment to environmental protection, injury prevention, and continual improvement of EHS management systems. Actively contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents and participating in EHS initiatives and training.