Director GMP

Summary

The Director is responsible for the full operations and expansion of the Cryo Store products & services, which includes but not limited to, Dry-Ice provisioning services, setting up a GMP-depot including primary & secondary packaging as well as storage and distribution of medicines, Genetically Modified Organisms, Cell lines and Production batches as well as hiring and managing the team.   

Roles and Responsibilities

• Full responsibility for the on-site operations of Cryo Store in Swalmen.
• Establish a GMP-depot including but not limited to warehousing, primary & secondary packaging and shipments.
• Achieve and maintain ISO9001, GDP, GMP certificates, accreditations and GMO related SOPs.
• Create and oversee GMP-compliance of Cryo Store documents (e.g. SOPs and TEQs), improving the compliance levels in alignment with our QMS and regulatory requirements.
• Provide expert guidance and support on GMP and compliance matters across the LabConnect/Cryo Store organization.
• Promote a culture of quality awareness and foster a compliance-oriented mindset.
• Collaborate with cross-functional stakeholders on qualification projects. E.g. room, equipment, primary and secondary packaging and shipment qualifications, including reviewing protocols and reports.
• Initiate and support deviations related to Cryo Store processes, including impact/risk assessment and root cause investigations.
• Oversee and ensure timely implementation of corrective and preventive actions (CAPAs) to mitigate risk, prevent recurrence, and improve compliance.
• Monitor and report monthly KPIs for deviations CAPAs and change controls.
• Serve as a liaison to the QA department to align and interpret GMP and quality matters.
• Prepare and coordinate audits and health authority inspections within Cryo Store, acting as SME when required and support the timely implementation of responses.
• Hire, train and managing a new team.
• Profit and Loss responsibility.
• Proactively manages client relationships and issues and makes recommendations for related process enhancements and business process optimization.
• Working collaboratively with senior management teams.
• Able to develop a model for further future global expansion.

Skills and Requirements

• Bachelor of Science in a Life Science discipline.
• 5+ year of experience in managing teams within the clinical supply chain.
• Experience with warehouse operations and vendor compliance is an advantage.
• Expertise in risk management/assessment contribution to solutions that meet regulatory requirements.
• Knowledgeable and experience with GMP regulation is a requirement.
• Adaptive to change, and excellent problem-solving and multi-tasking skills.
• Result oriented and a can-do mentality.
• Fluent in English, Dutch/German is a plus
• Experience working with MS Office.

• Drivers license.

Read more below and get ready for your next great employment adventure!

Some of the Perks our LabConnectors Love:

• We truly live our values: partnership, excellence, execution, collaboration, forward thinking, accountability, informed and nimble
• The ability to make an impact on a passionate and growing team
• Great communication on a smaller sized team
• A market based salary
• Tools to effectively do your job (laptop, phone reimbursement)

We are a growing and global team on a mission to create healthier communities by accelerating the development of new medicines. In addition to great perks and challenging work assignments, we invest in our people with enriching career growth opportunities.

We believe in a friendly and collaborative environment with open lines of communication. Join our team and discover how your work can impact the lives of people all over the world.

It is the policy of LabConnect to provide equal employment opportunities without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, marital status, veteran status, sexual orientation, genetic information, or any other protected characteristic under applicable law.

Equal Employment Opportunity Posters:
https://www.dol.gov/agencies/ofccp/posters 
 
If you have a disability and you believe you need a reasonable accommodation in order to search for a job opening or to submit an online application, please email talent@labconnect.com or call +1(423)722-3155.

For more information, visit www.labconnect.com