Role: Manager Process Transfer
Russell Taylor Group has a fantastic opportunity for a Process Transfer Manager to join a Global Medical Device company based in the area of Manchester. This is an excellent opportunity to join a growing company and develop within your career. You will be responsible for maintaining and planning all sections of the department budgets, coordinating the department activities in accordance with the company priorities and develop and maintain department metrics to show alignment with department & corporate goals.
- Responsible for guiding and developing staff members.
- Conduct standing staff meetings.
- Remain current on FDA & ISO requirements.
- Review and approve document change requests for design review and/or technical review.
- Lead the efforts to scale-up, validation and transfer of bulk/fill processes to production.
- Qualify necessary changes in raw materials and vendor's in-conjunction with appropriate functional groups at San Diego.
- Develop and qualify process parameters related to scale of process.
- Create Pilot docs for new & modified products.
- Responsible for complex validation protocols and reports.
- Provide oversight and guidance to technical staff for non-conformance investigations, complaint investigations, raw material qualifications, parts obsolescence management and document change requests.
- Develop Resource (from all Operations staff members) to manage loaded PSP projects.
- Ensures appropriate representation from Product support group on project core teams.
- Lead various improvement or system development projects as required by the Operations Excellence process, through the use of Lean tools and organization/ facilitation of Kaizen events.
- Manages process improvement and targeted cost containment/reduction initiatives.
- In conjunction with Marketing and the technical/field staff, develops a path forward to resolve investigations for MRB including communication to the customer. Additionally works with internal experts to develop a path forward to resolve backorders due to investigators for MRB
- BA or BS and 8-10 years related experience
- Working knowledge of; Laboratory safety / Chemistry / Biochemistry / Mathematics / Technical writing skills / Budgeting systems
- Enterprise Resource Planning (ERP) systems & Customer Relationship Management (CRM) systems
- Project management skills
- Working knowledge of QSRs, EN 13485, and all other regulatory guidance's as appropriate.
- Influencing skills