Associate Director, In-Market & Distribution Quality Leader (EU/MEA Region)
BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. We develop medicines for patients with significant unmet medical need and empower our teams to pursue bold, innovative science.
About Technical Operations BioMarin’s Technical Operations group creates 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 cutting‑edge manufacturing processes, provide quality assurance and quality control to meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.
Summary
The regional Quality Leader, EU/MEA, is a key role in the In‑Market & Distribution Quality (IMDQ) organization. This position oversees quality operations across clinical, commercial, distribution and supply chain activities of BioMarin products in Europe, Middle East and Africa (EUMEA). The Quality Leader ensures efficient and effective distribution and logistics operations, including warehousing, transportation and distribution, and drives continuous improvement initiatives.
Responsibilities
* Operational Management: Oversee daily quality operations of the logistics hub, ensuring quality requirements implementation and quality events resolution.
* Team Leadership: Lead, mentor and develop a team of “to the market” and “in‑market” quality operations professionals.
* GDP Program Management: Lead development, implementation and maintenance of GDP programs across EUMEA quality operations and act as GDP expert for regulatory inspections and internal quality reviews.
* Compliance: Ensure compliance with EU GDP Guidelines (2013/C 343/01), local regulations and BioMarin Quality Management System (QMS) framework; maintain distribution licenses and required documentation.
* Metrics & CAPA: Monitor, analyze and report quality key performance indicators (KPIs), trends and CAPAs to drive operational efficiency and effectiveness.
* Stakeholder Collaboration: Collaborate cross‑functionally with Quality, Regulatory Affairs, Supply Chain, Business Development, Clinical and Commercial teams to uphold the highest standards of distribution practices.
* Training & Development: Design and deliver GDP training programs for internal teams and external partners.
* Budget Management: Develop and manage the regional quality budget, ensuring cost‑effective operations while maintaining high quality levels.
* Process Improvement: Identify and implement quality process improvements to enhance operational efficiency and support internal stakeholders’ initiatives.
* Technology Utilization: Leverage global quality tools and systems to streamline operations and compliance.
* Change Leadership: Support and drive change management requirements through internal and external communication, developing the vision for the organization and empowering the IMDQ team members to make effective decisions.
Qualifications
* Education: Bachelor’s degree in Pharmacy, Life Sciences or related field; master’s degree is a plus.
* Experience: Minimum 8–10 years in pharmaceutical quality assurance, with at least 5 years focused on GDP in the EUMEA region; in‑depth knowledge of EU GDP Guidelines and regional regulatory requirements; experience managing audits, inspections and quality systems in a multi‑country environment.
* Leadership & Communication: Strong leadership and team management skills, excellent communication and interpersonal skills; ability to lead change initiatives and drive improvements across functions.
* Technical Knowledge: Proficiency in QMS tools and systems (Veeva, TrackWise, MasterControl QMS, SAP or similar); solid understanding of logistics and supply chain principles; detail‑oriented, analytical thinker and problem‑solver.
Preferred Attributes
* Strong problem‑solving skills with a global focus both internally and externally.
* Flexibility and ability to deal with changing priorities without losing sight of the overall business.
* Proactive and energetic outlook with an unwillingness to accept the status quo.
* Ability to work independently with strong time‑management skills.
Travel
Approximately 20% travel.
Equal Opportunity Employer
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status. No discrimination based on disability. All qualified applicants will be considered for employment. BioMarin is an equal opportunity employer.
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