Global Trade Compliance, Manager / Sr. ManagerLocation Cork, Ireland Workstyle Open to Hybrid Apply
For more than two decades, going our own way has led to countless breakthroughs, bettering the lives of those suffering from rare genetic disease. In 1997 we were founded to make a big difference in small patient populations. Now we seek to make an even greater impact by applying the same science-driven, patient-forward approach that propelled our last 25 years of drug development to larger genetic disorders, as well as genetic subsets of more common conditions. Through our unparalleled expertise in genetics and molecular biology, we will continue to develop targeted therapies that address the root cause of the conditions we seek to treat. Applying our knowledge to make a transformative impact is not just a calling, but an obligation to those who will benefit most. The end goal has always been better lives and now we can reach more.
And the more people we reach, the more our impact can grow. We transform lives through genetic discovery.
Our desire to make a positive impact on our patients extends to our employees and BioMarin is committed to fostering an inclusive environment where every person feels seen, valued, and heard – so employees can thrive in all areas of their lives, in and outside of work. We seek to provide an open, flexible, and friendly work environment to empower people and to provide them with the ability to develop their long-term careers. Ultimately, we want to be an organization where people enjoy coming to work and take pride in our efforts to help patients.
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. Come join our team and make a meaningful impact on patients’ lives.
The Global Trade Compliance, Manager / 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. Additionally, the Manager / Senior Manager will participate in the process analysis and improvement efforts with the Global Supply Chain Operations team as it digitizes the flow and exchange of information: maintaining compliance while automating tasks in the oversight and accounting of the movement of our materials within our ERP and via our visualization platform partners.
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.
- Responsible for regional GTC relating to BioMarin operations, and primary SME for assigned geographic area activities for affiliated Biomarin companies, 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.
- Primary contact and subject matter expert for all inquiries and requests for information related to GTC in the assigned geographic regions from personnel and international regulatory bodies
- 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
- Participation on local Launch teams to ensure GTC requirements are defined and captured as part of launch planning with a subsequent formal handover to the Logistics Operational teams
- Execution of Global Trade related projects and initiatives such as Known Consignor Status, Approved Economic Exporter, and Inward Processing Relief 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 regional Customs 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
- Shared responsibility for budget stewardship related to Duties and Taxes associated with the movement of BioMarin products
- Assist with determining distribution partner licensing requirements in regional countries to support GDP bona fides diligence
- Continually innovate to better processes that deliver products from production to patients
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 assigned regions.
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 Business, Supply Chain Management, Logistics, Operations Management, or similar required
- In lieu of above, other undergraduate degree plus continuing education in the logistics or extended supply chain management field required
- Demonstrated implementation of innovative ideas that transform how work achieves results
- Minimum of 5 years’ experience in the area of Global Logistics, with demonstrated experience of:
- Preparing import & export shipment documentation and working with freight forwarders and customs brokers
- Understanding and responsiveness to international Customs regimes, in-country authority requirements etc.
- Maintaining import and export data bases in compliance with reporting requirements
- Minimum of 3 years’ experience in a GxP Pharma/biotech role
- Minimum of 3 years’ experience in an international logistics environment
- 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 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.
Approximately 15% travel
Standard office desk equipment
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.
There will not be personnel supervisor responsibility associated with this role.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.