Who We Are Bio Marin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.
Since our founding in ****, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.
Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need.
We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science.
With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.
About Technical Operations Bio Marin'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 Bio Marin'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.
Associate Director, In-Market & Distribution Quality Leader (EU/MEA Region) Location: Dublin or Cork ( Hybrid role 2 days per week in the office) Closing date: Thursday 20th November **** SUMMARY DESCRIPTION The regional Quality Leader, EU/MEA, is a key role as part of the In-Market & Distribution Quality (IMDQ) organization.
This position will have quality operations responsibilities across the clinical, commercial, areas related to distribution and supply chain quality activities of Bio Marin products.
The Quality Leader is responsible for overseeing and managing the quality operations of Europe, Middle East and Africa (EUMEA) regional hub.
This strategic role involves ensuring efficient and effective distribution and logistics operations, including warehousing, transportation, and distribution.
The designated person should have strong strategic leadership skills, a deep understanding of Good Distribution Practice (GDP), and the ability to drive continuous improvement initiatives.
As the Associate Director of In-Market Distribution Quality Leader for the EUMEA region, should lead and oversee the strategic implementation and continuous improvement of GDP compliance across the company's distribution network.
This role ensures that all Bio Marin products are stored, handled, and transported in accordance with applicable regulations, maintaining product integrity and patient safety.
The role should serve as the regional GDP subject matter expert, collaborating cross-functionally with Quality, Regulatory Affairs, Supply Chain, Business Development, Clinical and Commercial teams to uphold the highest standards of distribution practices.
RESPONSIBILITIES Operational Management: Ensure overseeing daily quality operations of the logistics hub in the region, ensuring timely and accurate 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, fostering a culture of excellence and continuous improvement.
Lead the development, implementation, and maintenance of GDP programs across EUMEA quality operations.
Ensure compliance with EU GDP Guidelines *****/C ******), local regulations, and Bio Marin Quality Management System (QMS) framework.
Act as the GDP expert for regulatory inspections and internal quality reviews.
Ensure that the wholesaler distribution licenses are in place and maintained for the distribution operations carried out in the markets part of the EUMEA region.
Monitor and report and analyze quality key performance indicators (KPIs) metrics, trends, and CAPAs (Corrective and Preventive Actions) to ensure operational efficiency and effectiveness.
Collaborate with cross-functional teams to ensure alignment on GDP requirements and quality standards.
Ensure development and delivery of GDP training programs for internal teams and external partners.
Ensure maintenance of documentation and records to support GDP compliance and regulatory commitments.
Support global initiatives and harmonization efforts related to distribution quality and compliance.
Budget Management: Develop and manage the regional quality budget, ensuring cost-effective operations while maintaining high quality levels.
Compliance: Ensure compliance with all relevant regulations, including GDP, health and safety standards, and Bio Marin policies.
Process Improvement: Identify and implement quality process improvements to enhance operational efficiency and to support the internal stakeholders' initiatives.
Stakeholder Collaboration: Collaborate with internal and external stakeholders, including suppliers, customers, other distribution hubs and central functions, to drive quality in the supply chain.
Technology Utilization: Leverage global quality tools and systems to streamline operations and compliance.
Change Leadership: As a member of the In-Market & Distribution Quality Leadership team support and drive the change management requirements through communication internally and externally, developing the vision for the organization and empowering the IMDQ team members to make effective decisions.
SCOPEThis role is responsible for supporting the efficient distribution of lifesaving therapies in compliance with applicable regulations.
Decisions made in this role are of critical nature in mitigating risks for the business while ensuring Bio Marin's commercial and clinical products are delivered to patients in a timely and compliant manner.
The candidate should demonstrate the following attributes: A firm commitment to Bio Marin's cultural beliefs and values Consistent track record of exceeding objectives within area of influence Ability to achieve results through others without direct reporting lines Strong problem-solving skills with a global focus both internally and externally Possess a high level of accountability and demonstrate an ability to be a change agent in a highly regulated industry Flexibility and ability to deal with changing priorities without losing sight of the overall business Strong interpersonal, communication and influencing skills working with all levels and within an environment of constant change Proactive and energetic outlook with an unwillingness to accept the status quo Interaction and collaboration with team members, peers and senior management Ability to work independently with strong time management skills Approximately 20% travel EDUCATIONBachelor's degree in Pharmacy, Life Sciences, or a related field.
A master's degree is a plus.
EXPERIENCEMinimum 8-10 years of experience 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.
Strong leadership and team management skills, excellent communication and interpersonal skills.
Proficiency in QMS tools and systems, and a solid understanding of logistics and supply chain principles.
Detail-oriented, analytical thinker, problem-solver, and able to work in a fast-paced environment.
Strategic mindset with hands-on operational execution.
Proven ability to lead change initiatives and drive improvements within and across functions which enable compliance and mitigate risk Ability to effectively work autonomously and independently Understanding of Quality Tool: Veeva, Track Wise, Master Control QMS, SAP, or like technologies CONTACTSCommercial, Site Operations, Clinical Operations, Worldwide Research & Development Scientists, Contract Manufacturing, Quality Assurance, Finance External partners including 3 PL providers, transport carriers.
Health Authorities and National Regulatory Bodies Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position.
It is intended to describe the general nature of the job that may include other duties as assumed or assigned.
Equal Opportunity Employer/Veterans/Disabled An 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 and will not be discriminated against on the basis of disability.
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