Associate Director, Global Quality Systems
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.
The Associate Director, Global Quality Systems is responsible for the oversight and governance of BioMarin’s pharmaceutical quality systems, management of critical issues and product complaints. This role leads the global quality governance meetings, manages product complaint system and investigations, and ensures timely and effective escalation of critical issues.
This position requires a broad range of knowledge and experience with quality systems, global regulatory reporting requirements, adverse events and product technical complaints for small molecule, biologic, advanced therapy, and combination products.
This candidate would lead and empower a team that delivers a clear strategy to address and mitigate quality system related issues and to prevent recurrence of product complaints and adverse events.
The incumbent must possess technical expertise in the areas of responsibility and demonstrate technical and personnel leadership qualities.
- Manage and improve the global process issue management including deviation management and the process for escalating critical issues within BioMarin and to external authorities (local and international).
- Lead key quality system governance meetings to ensure appropriate management oversight of the pharmaceutical quality system.
- Identify and drive completion of quality system improvement initiatives.
- Define and identify harmonized quality system metrics.
- Manage and harmonize complaint handling and investigation practices across BioMarin.
- Provide technical expertise as required and provide recommendations and influence to global issues.
- Works cross functionally with leaders inside and outside of Technical Operations to agree on strategies and define actions regarding the health of the quality system and resolution of critical quality issues.
- Proven leader with demonstrated ability to build and lead successful cross functional teams.
- Own and oversee the compilation of the Annual Product Review (APR) and Site Master File (SMF) for BioMarin Products.
- Oversee the continuous improvement of our Quality Systems.
The work of the Associate Director Global Quality Systems will directly impact product revenue through the management of critical issues and communication with Health Authorities. The work will also ensure an aligned approach to compliance with GxPs across the Technical Operations (TOPS) function.
The Associate Director Global Quality Systems is a member of the Director of Global Quality Systems leadership team.
BS/MS/B.Sc/M.Sc./PhD preferably in the life sciences.
- 12+ years experience in pharmaceutical or related industry
- 6+ years of previous people management.
- Demonstrated knowledge of cGMPs, 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 issue management and escalation including and not limited to filing of FARs, BPDRs, PQDRs, Recalls, etc.
- Understanding and experience with oversight of the pharmaceutical quality system including good manufacturing, laboratory, clinical and distribution practices.
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.