Global Quality Manager External Manufacturing -100%
Posted on Apr 24, 2021 by Coopers Group GmbH
For our Pharma client based in Basel, we are currently looking for an experienced
Global Quality Manager External Manufacturing -100%
Start/Ende:01.06.2021 - 28.02.2022
Tasks and Responsibilities:
Operational or Management related activities: Global Management
o Daily responsibilities
- Assure and monitor the supplier and the client's products quality and compliance vs current regulations in force and client standards to assure the supply of finished goods and services
- Ensure Supplier and Product Monitoring & Management from QA point of view by establishing and maintaining Performance Dialogues with suppliers including supplier evaluation and CMO/product/processes risk assessments
- Act as Quality representative in front of main EM stakeholders (Procurement, Operations, Technical, Supply) within the Leadership Teams.
- Review and evaluation, approval of Deviations & Out of Specifications including root cause analysis. Accountable for determination and implementation of CAPA and effectiveness checks ensuring continuous improvement of Bayer product and process.
- Evaluate, from a Quality standpoint, change controls at CMOs related to existing portfolio, Transfers and Projects
- Monitoring and Evaluation of PQRs. On time communication to Country Quality Divisions
- Regular update of Quality Agreements established with CMOs
- Review and approve analytical validation protocols and reports, generated by third parties Support manufacturing/packaging process of existing and/or transferred/new products manufactured at CMOs. Review process validation protocols and reports in collaboration with Technical Management functions, ensuring Continuous Process Verification and Statistical Process controls run according to relevant client's and Health Authorities guidelines and that are properly reported by CMOs to our client.
- Ensure within area of expertise, proper follow up and timely completion of transfer activities at CMOs
- Where applicable liaise with Innovation & Development for activities under responsibilities in New Product Developments (NPDs). Assess and approve quotations related to Projects and NPD quality activities.
- Review and approve Stability protocols and reports. Align on Stability strategies applied at CMOs to demonstrate Product Quality along shelf life.
- Accountable to establish and maintain a Quality Risk Management culture at CMOs. Review and approval of related Risk Assessments and control strategies.
- Where applicable, contribute to the selection, qualification and phase-out of CMOs according to client's standards.
- Contribute during regular internal preparations for planned audits at CMO. To ensure that Audit & Inspections CAPA are properly and timely implemented.
- Contribution to PQSC and Critical Issues investigations/CAPA implementation and review of CMO Complaint trending review together with Complaint Managers.
- Regular training of suppliers in client's related requirements
- Collaborate with Q EM Head on strategy definition to ensure deployment execution within Quality EM Accountable and responsible for timely accomplishment of assigned strategic initiatives and projects
- Where applicable, liaise and assure coordination of actions with affiliate entities according to the business requirements
o Special tasks
- Ensure Readiness of our client's Global Third Party Manufacturers including performance monitoring providing quality oversight and assuring compliance and implementation of cGMP and other relevant quality regulations at these sites.
- Accountable for Quality oversight and Products/Processes Capability on all formulations manufactured at the Global CMOs within scope of responsibilities.
- Participate and contribute into CMO Lifecycle (Selection, Qualification and Phase-Out)
- Support strategy deployment and business needs contributing, as QEM representative, to relevant decision boards.
- Ensure Processes and Standards are followed within Quality External Manufacturing in order to better support business needs with regards to suppliers and products from a QA standpoint.
- Steer the Supplier and Product Evaluation Management processes for QEM Managed Global suppliers from a Quality perspective
- Participate in Operational Excellence and Product Supply System initiatives and tools with the objective to Continuous Improve
- Minimum BS in life science or Pharmacy
- Minimum 7-8 years of experience in QA, QC and/or Manufacturing in pharmaceutical/life science industry
- IT Tools: SAP,
- Languages: Proficiency in English, written and verbal, with ability to communicate to different audiences. Additional languages are beneficial.
- Soft skills:
- Readiness in working within innovation and digitalized environment
- Agile learner with ability to anticipate needs and be pro-active.
- Cross-functional team Player with excellent communication and negotiation skills for international interactions
- Demonstrate workload prioritization and time management
- Strong flexibility to adapt to different business cultures
- Experience working with External Manufacturers
- Strong analytical and problem-solving skills
- The position requires mature management, communication skills and political sensitivity to successfully operate in a complex international Matrix organization. This includes that the incumbent can operate within the External network and different stakeholders, establishing an efficient collaboration in order to ensure quality and compliance of the client's contract manufacturers.
- The incumbent must be capable to contribute to an organized structure that will service the implementation of quality initiatives in order to enhance supplier readiness and product robustness identifying in advance potential risks.
- Maintaining a continuous integrated interactive approach with the various functions concerning operations and business management will be mandatory.
- Decisions of the incumbent have direct influence on production and personnel cost, service levels and time to market, as well as the results of inspections and the amount of technical complaints and recalls of the external manufacturing network
- Furthermore, the incumbent influences the global CH business and participates in the oversight and continuous improvements of our CMOs quality management systems.
Nice to Haves:
- Certifications: Lean six sigma or Operational excellence certification
- Specific industry: Cosmetic, Dietary/life science industry
- Additional languages: Are Beneficial