Description

Who We Are

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.

Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.

Our manufacturing and process development teams manage the production of our therapies for clinical trials and commercial markets. These engineers, technicians, scientists, and support professionals continually provide quality assurance and ensure we meet all regulatory standards. We have manufacturing facilities in Northern California and in Cork, Ireland. Additionally, our supply chain teams procure the goods and services needed to support manufacturing and worldwide distribution.

About Technical Operations

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.

Executive Director, Global Supply Chain & In-Market Quality

Summary

The Head of Supply Chain & In‑Market Quality is an enterprise leader accountable for global Good Distribution Practice (GDP) compliance, in‑market quality execution, and oversight of Responsible Persons (RPs) and Deputy Responsible Persons (DRPs) across affiliates. The role ensures reliable, compliant, and resilient product supply, safeguarding patient experience while operating across complex regulatory environments, including local testing laboratories, while operating within a globally governed quality and supply framework.

This leader bridges global quality standards and local market execution, providing authoritative oversight of distribution, in‑market release, third‑party partners, and quality systems, while serving as a trusted partner to Supply Chain, Regulatory, Commercial, Clinical, and Communications.

• Leading the global affiliate supply chain and in market quality network, ensuring consistent execution across diverse regulatory environments
• Owning GDP compliance across third party logistics providers, warehouses, distributors, and transportation lanes
• Providing governance and oversight of in country quality operations, including local testing laboratories, sampling, stability, and market release activities where applicable
• Ensuring inspection readiness and effective management of regulatory authority inspections, audits, and health authority interactions at the affiliate level
• Driving risk management, deviation oversight, CAPA effectiveness, and quality metrics related to distribution and in market activities
• Establishing clear accountability, escalation, and decision making frameworks for market supply and quality issues
• Leading continuous improvement initiatives to strengthen resilience, compliance, and operational efficiency across markets
• Developing and mentoring affiliate leaders, fostering a strong quality culture and patient first mindset

• WDA & GDP Compliance - Ensure ongoing compliance with Wholesale Distribution Authorizations (WDA) or equivalent licenses and applicable GDP regulations across all affiliates.
• Global GDP Framework & Regulatory Intelligence - Establish, maintain, and continuously improve global GDP processes and standards, including regulatory surveillance and implementation of regulatory changes.
• In‑Market Release & GMP Oversight - Ensure in‑market release requirements are defined and maintained in compliance with local GMP regulations, including oversight of release partners and testing laboratories.
• Product Disposition Authority - Approve final disposition of returned, rejected, recalled, expired, or falsified products, including decisions on returns to saleable stock.
• Market Launch & Lifecycle Quality Readiness - Lead quality assessments for new product launches, indications, markets, and distribution models, ensuring GMP/GDP readiness and cross‑functional alignment.
• Quality Management System (QMS) Leadership - Design and sustain an effective in‑market QMS covering risk management, deviations, investigations, CAPAs, change control, KPIs, and management review.
• Self‑Inspection & Inspection Readiness - Ensure robust self‑inspection programs are executed and corrective actions implemented, maintaining continuous inspection readiness.
• Supplier & Partner Qualification - Govern supplier, distributor, and 3PL qualification programs, including approval of subcontracted activities impacting GDP.
• Transport, Storage & Distribution Oversight - Provide quality oversight of logistics, transport, and storage providers, including audits, performance monitoring, and remediation.
• Customer Qualification & Due Diligence - Maintain customer qualification programs and ongoing compliance checks to protect supply chain integrity.
• Complaints, Recalls & Market Actions - Ensure effective management of product quality and logistics complaints and lead recall operations in coordination with MAHs and competent authorities.
• Responsible Person (RP) Governance & Capability Building - Provide senior leadership and governance for affiliate RPs/DRPs, including delegation oversight, role clarity, training, and capability development.
• Clinical Stock Recovery - Partner with Clinical Operations to manage compliant recovery of investigational medicinal products.
• Supply Chain Security & Falsified Medicines Compliance - Ensure compliance with Falsified Medicines regulations and implementation of robust supply chain security controls.

• Works autonomously on the accomplishment of agreed upon goals and objectives.
• Success in this role requires the ability to balance global standardization with local execution, exercise strong judgment during supply or quality events, and act as a trusted leader to affiliates, regulators, and global governance bodies.
• Proactively identifies and reports discrepancies from normal practices or procedures to senior management, recommending and implementing plans for improvements.

• Prior accountability for GDP / WDA-like licenses (or direct oversight of named RPs/DRPs)
• Demonstrated experience leading GDP compliance for wholesale distribution authorization/license holders and ensuring licensed operations do not compromise product quality.
• Experience establishing and running the key RP-controlled elements (QMS, training, supplier/customer approval, subcontractor approval, self-inspections, recalls/returns dispositions).
• Global oversight of third-party distribution networks
• Led qualification and governance of 3PLs, distributors, transport lanes, warehouses (including audits, quality agreements, deviation/CAPA governance). This aligns to GDP expectations for outsourced activities and supplier controls
• Inspection leadership with positive outcomes (GDP/GMP interfaces)
• Led or co-led regulatory inspections/audits affecting distribution and in-market quality systems (GDP), and managed inspection responses and CAPAs to closure.
• End-to-end event leadership: recalls, returns, falsified product, cold chain excursions
• Direct experience coordinating recalls and executing disposition decisions on returned/rejected/recalled/falsified products and approvals for returns to saleable stock—core RP-accountable activities.
• In‑market release models / local testing labs oversight (where applicable)
• Experience designing and governing in‑market release requirements (testing/release partners, local GMP expectations, quality agreements, oversight of labs or contract labs). While the EU GDP guideline is GDP-focused, it explicitly anchors QMS, authorized activities and quality records—this role needs proven capability at that interface.
•  Active participation in company business growth objectives for quality alignment.

• The Head of Supply Chain & In‑Market Quality is always “A” for decisions that regulators expect to be owned by the RP function (GDP, disposition, recalls, QMS effectiveness, partner approval).
• Accountable for go/no-go decisions on licensed GDP operations, partner qualification, QMS effectiveness, RP/DRP governance and delegation, product disposition (returns/rejects/recalls/falsified), recall execution, and inspection commitments, ensuring product integrity and patient protection across markets.

• Must possess a Bachelor's degree in Sciences, preferably in Pharmacy
• Advanced degree (MS/MBA/PhD) helpful for enterprise leadership in global networks, vendor ecosystems, and complex governance

• 10–15+ years in biopharma/regulated distribution quality and/or supply chain quality leadership.
• Proficient in cGMPs, GDPs and regulations promulgated by the FDA, EMA or equivalent regulatory Agencies; ISO 9001:2000 regulations; and requirements for pharmaceutical products distribution.
•  Leading a multi-country network of accountable persons (RP/DRP equivalents) and managing suitability, training, and performance in inspection-facing contexts.
• Direct accountability for GDP/WDA or equivalent and oversight of RPs/DRPs across multiple geographies
• Demonstrated success in GDP inspections/audits and CAPA closure
• Proven governance of 3PLs/distributors/release partners/labs (qualification, audits, quality agreements)
• Track record leading recalls/returns/falsified product disposition and cold-chain deviation decisions
• Strong cross-functional influence and crisis leadership (Supply/RA/Clinical/Comms)

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.