Title: Associate Director Global Quality Management Systems
The Associate Director, Global Quality Management Systems is responsible for the oversight and maintenance of the Quality Management System for BioMarin’sTechnical Operations department. This includes establishment, continuous improvement, and ensuring the consistent implementation of global quality system policies across the Technical Operations network.
This position requires a broad range of knowledge and experience with clinical and commercial quality systems regulations focused on the development, manufacture and delivery of small molecule, biologic, medical device/combination, and advanced (gene) therapy medicinal products.
This candidate leads risk assessment and mitigation activities to establish and improve the Quality Management System. The candidate works cross functionally within Technical Operations and across impacted BioMarin functions to align the approach to quality across Worldwide Research and Development, Global Compliance and Technical Operations.
The incumbent must possess technical expertise in the areas of responsibility and demonstrate technical and personnel leadership qualities.
- Ownership of the BioMarin Quality Management System including the Quality Manual and associated quality policy.
- Ownership of global Quality System procedures (Standard Operating Procedures and Policies) (examples: Change Control, Deviation, Corrective and Preventive Action, Document Management,).
- Collaboration with local Quality teams to ensure adherence and alignment to global policies.
- Responsible for ensuring that the quality management system drives compliance to all applicable regulations and is scalable and appropriate for the organization and product portfolio.
- Partners within Technical Operations and across BioMarin to streamline and continuously improve Quality systems, ensuring compliance with regulatory requirements.
- Responsible for the timely completion global compliance, deviation, and CAPA commitments.
- Ensures consistency in implementation of global processes, CAPAs, and inspection responses.
- As needed, partner with Corporate Compliance to perform site Quality inspections within BioMarin with the goal of compliance to regulations and site harmonization.
- Provide SME support to site inspections, global inspections, and related observation responses.
- Keep abreast of new regulations and Quality trends within the Pharmaceutical industry through literature review, professional conferences, and benchmarking organizations.
- Management of key quality system projects driving alignment at senior levels of the organization.
The work of the Associate Director, Quality Management System oversees foundational business processes which will directly impact product revenue through the assurance of compliance to Health Authority regulations. This compliance is necessary to do business in these areas and is evaluated through routine audits and market applications. The work will also ensure an aligned approach to compliance with GxPs across the Technical Operations (TOPS) function.
The Associate Director of Quality Systems and Issue Management is a member of the Director of Global Quality Systems leadership team.
BS/MS/B.Sc/M.Sc./PhD preferablyin the life sciences.
- 12+ years experience in pharmaceutical or related industry
- 6+ years of previous people management.
- Demonstrated knowledge of cGxPs, Health Authority Regulations, Quality Systems and technical expertise in a manufacturing processes. Knowledge of devices, combination products and device development desirable.
- International/global experience preferred
- Proven leadership, organizational and management skills to coordinate cross functional decision making with executive leadership.
- Ability to speak, present data, and defend approaches in front of audiences and inspectors.
- Ability to comprehend technical information related to analytical methods, processes, and regulatory expectations.
- Experience with participation in regulatory inspections presenting or defending subject matter area in audits or regulatory inspections.
- Understanding and familiarity with FDA, European and international regulatory requirements, guidelines, and recommendations for quality system implementation including but not limited ICH 10 and ISO 13485.
- Understanding and experience with oversight of the pharmaceutical quality system including good manufacturing, laboratory, clinical and distribution practices.
This position will interact with all other departments throughout the organization. This position will partner and influence with Regulatory Affairs, Compliance, Process Development, Supply Chain, Technical Operations, WWRD, and other departments as required. This position requires constant contact with Senior and executive management across the organization.