For one of our Pharmaceutical clients in Beerse, Belgium we are looking for a for a Professional working on the execution of PES supplier initiated change controls for API, intermediate, Raw Material and Packaging to join the Department of Supply Chain (JSC) PES (Partnerships and External Supply).
- Execution of PES supplier change control processes in conformance to current standards and procedures, using applicable system application tools.
- Ensure integrity, consistency and compliance of processes for JSC globally.
- Assure successful implementation of changes and actions by following up and synchronizing activities for all participants, communicating status for implementations to key stakeholders
- Provide product and Supply Chain knowledge to ensure proper implementation and compliance
- Partner with other areas of Supply Chain and actively develop and manage relationships with process users, business owners, affiliates and external organizations.
- Bsc in Physical or Life Science; Supply Chain and/or Chemical Engineering
- 3-5 years of related experience, including significant experience in pharmaceutical or other related highly regulated industry
- Min. 3 years’ experience in leading virtual teams
- Strong Project Management Skills
- Demonstrated experience to lead complex change implementations confidently.
- Demonstrated understanding of manufacturing processes and associated GMP compliance requirements. Able to apply this knowledge to lead and develop change control process strategies for global needs
- Demonstrated understanding of global Regulatory Affairs legislation and Regulatory Compliance requirements. Able to apply this knowledge to evaluate changes and assess potential risk introduced to the business as result of changes
- Systems knowledge: Can be learned on the job, but proficiency in Excel, Word, etc. is preferred.
- Ability to engage and align with other diverse and dispersed organizations and functions.
- Ability to negotiate, influence and lead without direct line authority.
- Ability to engage others and lead an organization through continuous improvement and change.
- Excellent communication (phone, e-mail) skills
- Have attention to detail and are organized; follow and establish processes
- Proficient in written and spoken English and Dutch
- Ability to work independently
- Ability to understand the content of changes
- Position: Sr Specialist Change Control Management (medior/senior)
- Location: Beerse, Belgium
- Start date: ASAP
- Duration: 6 months or 1 year (depending on experience, open to extensions)
- Onsite/Offsite: on-site/ 1 day a week
- FTE (%): 100% (no 80% FTE)
- Workload: 30-40% meetings, 5000 change controls per year, a lot of follow-up work
- Team size: 12 people (across USA and EMEA)
Interested? Apply now, send your CV to Khanyi Mabena at email@example.com or call +31202044502.