Technical Manager, Global Supplier QualityLocation Novato, California Apply
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. Come join our team and make a meaningful impact on patients’ lives.
This position reports to the Head of Global Supplier Quality and will support and maintain Quality oversight for one of the Global Supplier Quality processes associated with the following: Raw Material Supplier Changes, Supplier Investigations, the Approved Supplier List (ALS) and associated Purchasing Controls and Quality Agreements for Raw Material Suppliers, and Raw Material Specification Oversight.
- Oversight and approval as required for supplier related activities impacting GxP operations at BioMarin, including and not limited to Supplier Changes, Investigations, Specification Changes and Quality Agreements. The focus of this position is Business Process Ownership for the Supplier Change Notification (SCN) process. Future opportunities available to expand oversight for additional areas.
- Provide technical expertise and oversight to resolve Quality issues related to associated business systems and processes.
- Compile Supplier Performance metrics; including metrics for supplier changes, deviations, and other measures of supplier performance.
- Accountable for operations and results of identified scope. Establish and influence global alignment on policies and procedures.
- Lead and participate in cross-functional Supplier Quality meetings.
- Develop Supplier related policies, and continuously evaluate and improve practices and across Technical Operations and beyond as applicable (e.g. Regulatory, Compliance). Strive toward constant improvement of systems in order to maintain compliance cGMP requirements for work performed.
- Monitor performance of QMS records to assure timely completion of activities, including interpretation of Quality metrics to provide inputs to governance meetings and improved performance as needed.
- Represent Global Quality Assurance in multi-departmental meetings & project teams.
- Work cross-functionally with leaders inside and outside Technical Operations to align strategies and define actions regarding health of Global Supplier Quality processes.
- Participate in inspection preparation, train employees in inspection requirements and participate in regulatory inspections.
- Maintain current knowledge of industry standards and regulatory requirements for products developed or manufactured by BioMarin and for Supplier related approaches utilized at BioMarin.
- Support CMC regulatory filings for all drug products.
- Ensure all individual training and group-specific guidelines are kept current.
- 8+ years experience in a GMP regulated environment, with exhibited knowledge and proficiency working within quality systems (specifically Change Control) preferred.
- 4+ years experience in a leadership position, with direct experience overseeing Supplier Quality Systems preferred.
- Organizational and management skills, with ability to effectively plan, schedule, execute, and track complex projects.
- Ability to speak, present data, and defend approaches in front of executive leadership and regulatory inspectors.
- Ability to comprehend technical information related to regulatory expectations and raw materials.
- Experience with cross functional project management.
- Experience with Supplier, Service Provider or Raw Material processes strongly preferred.
- Experience with TrackWise preferred.
- Experience working with international project teams preferred.
- Experience in participation in regulatory inspections, with experience in presenting or defending departmental functions in audits or regulatory inspections preferred.
- BA or BS in a technical discipline (physical or biological sciences). Equivalent experience may be considered.
- This position requires ability to utilize a computer to perform tasks, including report generation.
- Ability to perform gown activities and enter the manufacturing plant and QC laboratories is required.
- Ability to navigate the non-gowned areas of the facility, including utility yard and mezzanine is required.
- This position will require interaction with all levels (from employees up to Senior/Executive Management) in Technical Operations, Clinical Operations, Pharm/Tox, R&D, Business Operations, Finance, Information Technology, and Administration.
- This position will not have any direct reports
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.