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. 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.
The Global Trade Compliance Operations Senior Manager, operates within a center led Global Supply Chain framework. This position will have responsibilities across the clinical, commercial, and development science areas related to the Global Trade Compliance (GTC) activities of BioMarin. This role is responsible for ensuring a consistently smooth and compliant movement of finished goods, drug product, intermediates, raw materials, and research products across international borders.
Note that individual responsibilities may include all or part of responsibilities defined below depending on individual experience and abilities and may change to best support ongoing business needs.
Responsible for regional GTC relating to BioMarin operations, and primary SME for US import activities for BioMarin, ensuring that all shipments are conducted in compliance with international regulatory requirements and are not adversely impacted due to failure to comply with regulatory requirements.
Active participation in the development, implementation and continuous improvement of corporate wide GTC programs encompassing an organizational policy and supporting procedures to include audit readiness, risk mitigation and training
Participate in Global Trade related projects and initiatives such as Duty Draw Back and Customs Reconciliation, First Sale for Export programs.
Ensuring key performance indicators are utilized to measure and improve critical aspects of GTC adherence
Driving business solutions and continuous improvement initiatives which will add value to the Supply Chain function and the wider company
Development and maintenance of internal and external relationships through effective communication to foster GTC Compliance within and across BioMarin functions
Monitor Customs Community Directives and biopharmaceutical regulations, aligning current processes to comply with changing requirements
Audit regional trade documentation retention and incorporated shipping and customs declarations for accuracy including valuation, HS classification, and country of origin determination
Work with stakeholders to ensure proper correct valuation of products
Coordinate and advise on contract terms and conditions, Incoterms and analysis of trade lanes
Provide oversight and performance management of outsourced brokerage services
Maintain accurate and up-to-date records of import and export transactions and the compliance documentation.
This role is responsible for supporting the efficient movement of lifesaving therapies in compliance with applicable GTC regulations. Decisions made in this role are of critical nature in mitigating risks for the business while ensuring BioMarin's commercial products are delivered to patients in a timely and compliant manner.
In addition, this remit of this role includes import/export assessment of drug product, intermediates, raw materials, and research materials as they relate to BioMarin in the US region.
The candidate should demonstrate the following attributes:
A firm commitment to BioMarin'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
Bachelor's degree in Logistics, Supply Chain Management, Business Administration, or a related field. Customs Brokerage License preferred
Minimum of 10 years' experience in the area of Global Trade & Compliance with demonstrated experience of:
Understanding and responsiveness to international Customs regimes, in-country authority requirements etc.
Implementing duty mitigation programs eg. Duty Draw back, First Sale for Export.
Minimum of 3 years' experience in a GxP Pharma/biotech role
Cold Chain experience highly desirable
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
Commercial Operations, Site Operations, Clinical Operations, Worldwide Research & Development Scientists, Contract Manufacturing, Quality Assurance, Finance
External partners including 3PL providers, transport carriers, and customs clearing agents.
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.
Sr Manager Global Trade Compliance Operations • Washington, DC, US