Senior Manager, Global Specifications and Supplier Changes
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.
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 Product Infrastructure and will support and maintain Quality oversight for Change Control activities associated with the following Business Systems and Processes: Product and Raw Material Specifications, Product Release Controls and Raw Material Supplier Changes.
- Leadership and oversight for Supplier Changes, Product and Raw Material Specifications and Release Control (PRC) processes.
- Provide technical expertise and oversight to resolve Quality issues related to change control activities associated with Product and Raw Material Specifications and Supplier Changes and associated release requirements.
- Driver for alignment of business processes related to specifications and changes within External Quality organization.
- Oversee product specification document lifecycle. Approve product specification documents, following MAA/BLA/CTA/IND/IMPD filings provided by Regulatory Affairs.
- Oversee the creation of manual Certificates of Analysis and approve corresponding Change Controls.
- Business Process Oversight for the Product Release Controls (PRC) system, including support for PRC tickets to assure timely product release.
- Oversight and approval as required for Supplier related activities impacting GxP operations at BioMarin, including and not limited to Supplier Changes and Raw Material Specifications
- Accountable for operations and results of identified scope. Establish and influence global alignment on policies and procedures.
- Develop, maintain and improve related policies and procedures, and continuously evaluate and improve practices and systems to coordinate with validation, documentation, and regulatory systems. Strive toward constant improvement of systems to maintain compliant cGMP requirements for work performed.
- Oversee the management of required actions with departments and collaboration with support groups to meet quality commitments and established timelines.
- Monitor performance of Trackwise Records to assure timely completion of activities, including interpretation of Quality metrics to provide inputs to governance meetings and improved performance as needed.
- Maintain current knowledge of industry standards and regulatory requirements for products developed or manufactured by BioMarin and for Supplier related approaches utilized at BioMarin.
- Represent Global Supplier Quality and Product Infrastructure (GSQ&PI) at multi-functional meetings
- Work cross functionally with leaders inside and outside Technical Operations to align strategies and define actions regarding health of the GSQ&PI systems.
- Participate in inspection preparation, train employees in inspection requirements and participate in regulatory inspections.
- Ensure all individual training and group-specific guidelines are kept current.
- Other duties as assigned.
- 10+ years experience in a GMP regulated environment, with exhibited knowledge and proficiency working within quality systems (specifically Change Control) preferred.
- 6+ years experience in a leadership position, with direct experience overseeing Quality Systems preferred.
- Experience with staff development and organizational change management
- 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 audiences and inspectors.
- Ability to comprehend technical information related to regulatory expectations.
- Experience with cross functional project management.
- Experience in participation in regulatory inspections, with experience in presenting or defending departmental functions in audits or regulatory inspections preferred.
- Experience with TrackWise preferred.
- Experience working with international project teams preferred.
- BA or BS in a technical discipline (physical or biological sciences). Equivalent experience may be considered.