Sr. Manager, QA Lot DispositionLocation 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.
The Head of Lot Disposition for Novato Quality Assurance is responsible for assessing and releasing clinical and commercial product from four production facilities, assuring both completeness and accuracy of the data generated to support lot disposition in all jurisdictions according to the worldwide dossiers. This role requires the ability to understand, interpret and apply quality, regulatory and compliance standards in a GMP compliance manner. The BioMarin Novato Galli facility manufactures multiple commercial and clinical biologic products through Formulated Bulk Drug Substance and the BioMarin Leveroni facility manufactures Drug Substance and Drug Product for Gene Therapy applications.
The successful candidate will engage and interact with a range of people as part of the process, including members of the site leadership teams as well as leaders from other functions, including Supply Chain, Finance and Engineering. This leader will demonstrate the ability to think through scenarios, understand intricacies and be empowered to execute lot disposition activities.
This position requires deep understanding and proven application of cGMP regulations and international guidelines (ICH, ISPE, WHO, etc.) in a production setting. This knowledge would combine with clear decision making and align with quality risk management principles to assure the lot disposition is appropriate for clinical and commercial use.RESPONSIBILITIES
There are several specific responsibilities for the Head of Lot Disposition, including the execution of the process to apply the quality standards and procedures in order to assure complete and acceptable batch records.
- Mentor, advise and develop staff by teaching quality and “explaining the why” so they enjoy their careers at BioMarin.
- Through actions, drive a data driven and risk based culture of Quality across the manufacturing facilities.
- Advise, monitor and oversee the lot disposition process, including escalation of issues as appropriate.
- Coordinate with the QP Release Process, and invest in process improvements to gain alignment and reduce rework.
- Identify opportunities to improve quality, reduce cycle time, reduce COGs, and increase operational efficiency as it relates to lot disposition. Partner with key stakeholders to prioritize projects aligning with the quality goals and objectives.
- Create and maintain actionable metrics that improve behaviors and result in process optimization.
- Act as the single point of contact for Quality on in the Sales and Operation Execution team, aligning site priorities to meet supply chain demands.
- Partner with BioMarin QPs to ensure timely release.
The Head of Lot Disposition, Novato will directly support product release and its impact on financials.
The Head of Lot Disposition, Novato is a member of the Novato Site Quality Leadership Team, and a member of the Extended Quality Leadership Team.EDUCATION
- Bachelor's degree in science (e.g., biology, chemistry, pharmacy, medical), math, engineering, industrial engineering or a related field.
- Advanced degree in technical or business administration related field.
Required Experience and Abilities:
- 5+ years of relevant operations experience
- 3+ years in a role with demonstrated management skills and business acumen
- Demonstrated ability understanding the end to end aspects of a lot release process, including COA aspects.
- Proven communication skills in presenting data and concepts, as well as defending quality systems to auditors and cross-functional audiences
- An understanding of Health Authority regulatory requirements, guidelines and expectations
- Demonstrated ability to partner with other functional groups to achieve business objectives.
- Strong attention to detail and creative problem solving skills
- Ability to identify and resolve technical issues related to lot disposition, and manage multiple priorities.