Sr. Manager, Global Trade Compliance Operations
Description
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.
SUMMARY DESCRIPTION
The Global Trade Compliance Operations Snr 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 on going business needs.
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.
RESPONSIBILITIES
• 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.
• 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.
SCOPE
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
• 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
EDUCATION
- Bachelor's degree in Logistics, Supply Chain Management, Business Administration, or a related field.
- Customs Brokerage License preferred
EXPERIENCE
• Demonstrated implementation of innovative ideas that transform how work achieves results
• Minimum of 5 years’ experience in the area of Global Trade & Compliance with demonstrated experience of:
o Understanding and responsiveness to international Customs regimes, in-country authority requirements etc.
o 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
• Demonstrated implementation of innovative ideas that transform how work achieves results
• Minimum of 5 years’ experience in the area of Global Trade & Compliance with demonstrated experience of:
o Understanding and responsiveness to international Customs regimes, in-country authority requirements etc.
o 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
WORK ENVIRONMENT / PHYSICAL DEMANDS
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The employee may frequently be required to sit and talk or hear. The employee is occasionally required to stand; walk; use hands and fingers, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and taste or smell. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities by this job include close vision, depth perception and ability to adjust focus.
EQUIPMENT
Standard office desk equipment
Standard office desk equipment
CONTACTS
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.
SUPERVISOR RESPONSIBILITY
There will not be personnel supervisor responsibility associated with this role.
There will not be personnel supervisor responsibility associated with this role.
CAREER DEVELOPMENT
Refer to Responsibilities section
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.
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.
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.