Reference #: 391814
Site Name: UK - Hertfordshire - Stevenage, Belgium-Rixensart, Harlow, USA - North Carolina - Zebulon, USA - Pennsylvania - Upper Providence, Ware RD
Posted Date: Mar 28 2024Head of Clinical Supply Chain Cross Border ComplianceGSK is seeking motivated and energetic Head of Clinical Supply Chain Cross Border Compliance who is accountable for ensuring the compliant movement of clinical supply chain materials across country borders.The role works across a wide range of boundaries and has four main components: leading the global import / export service for the Clinical Supply Chain (CSC); creating and developing a cross border strategy that is compliant with evolving country regulation; mentoring and developing a team; and creating an effective data strategy to monitor and review the movement of material across borders. This role is pivotal to support the progression of GSK's pipeline, supplying medicine to patients in GSK's clinical trials. In this position you will support the Executive Director, Packaging, Labelling, Distribution and Comparators (PLDC) in the PLDC Leadership Team.The role is accountable for the strategy and execution of all CSC material movement across country borders to deliver medicine to support Phase I - IV clinical trials. As the Head of Clinical Supply Chain Cross Border Compliance, you will create an open, thriving, and safe space for our people to be their best selves.We encourage you to bring your collaborative spirit, disruptive thinking, team-leadership, and diverse perspective to our organisation.Key Responsibilities
Compliance Strategy: Develop and implement a comprehensive compliance strategy that aligns with the CSC's cross-border operations and R&D activities. Responsible for Customs Broker management and auditing.
Regulatory Compliance: Ensure the CSC's R&D cross border material movements comply with all relevant international laws, regulations, and standards. This includes managing regulatory submissions, audits, and inspections.
Risk Management: Identify, assess, and mitigate compliance risks associated with cross-border CSC R&D activities. This includes conducting regular reviews and implementing risk management strategies.
Training and Education: Develop and deliver training programs to educate employees about compliance requirements and best practices.
Compliance Monitoring: Monitor the company's compliance with its policies and procedures, as well as with applicable laws and regulations. This includes conducting regular compliance audits.
Reporting: Regularly report to senior management and relevant stakeholders on the company's compliance status, including any breaches or issues that arise.
Stakeholder Management: Work closely with various stakeholders, including R&D teams, Finance, legal teams, and external regulatory bodies, to ensure compliance of material movement across borders. Provide consultancy for the CSC distribution depot strategy and execute fully compliant cross-border movement of medicines and vaccines to patients
Continuous Improvement: Continually review and improve the company's compliance processes and systems to ensure they remain effective and efficient.
Develop and execute the strategic utilisation of duty & VAT relief programmes in combination with compliant valuation and tariff classification methodologies. Accountable for the assessment and ongoing monitoring of global customs agreements for CSC activities, customs provisions for R&D projects, and customs regulatory expectations.
Crisis Management: Respond to any compliance issues that arise, including managing any investigations or enforcement actions.Why You?Basic Qualifications:
Bachelor's degree or equivalent experience, and strong experience working in an GMP / GDP environment, demonstrating a quality culture, compliance, and performance.
Experience and required knowledge for the movement of medicines and vaccines in a GMP environment ac oss borders to supply patients in a GCP environment.
Strong knowledge of US FDA, US Dept of Agriculture, and global INCO Terms.
Strong experience and working knowledge of customs and regulatory body ways of working.
In depth working knowledge of GMP and country specific regulations to consult as an expert resource to the staff and customer groups.
Demonstrated experience managing resources and budgets.
Strong knowledge of Supply Chain activities in a Pharmaceutical or Vaccine backgroundPreferred Qualifications:
An open and curious mindset and the ability to provide a supportive, open, and inclusive leadership to develop and inspire our great team.
People and matrix leadership skills.
Excellent presentation and communication skills.
Higher degree in relevant discipline
Experience in change management and/or, implementing new systems.
In depth knowledge of R&D supply chain processes.
Experience in supplier relationship management, building a collaborative, performance focused relationship with GSK's third-party logistic providers.
#Hybrid
Why Us?
GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class(US only).We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on or 0808 234 4391.Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a UK Recruitment FAQ guide. Click the and scroll to the Careers Section where you will find answers to multiple questions we receive .As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete i