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Quality control associate director h/f

Neuenburg
Inserat online seit: 14 Juni
Beschreibung

LHH Recruitment Solutions is a specialized talent recruitment agency. We provide tailored services to help companies find the best candidates for their staffing needs.

With deep industry expertise and a commitment to excellence, LHH RS is a trusted partner in Switzerland for many years.

Our client is a pharmaceutical company based in Canton de Neuchâtel

Quality Control Associate Director H/F

1. Guide, mentor & develop your teams to achieve an environment of personal accountability and trust.
2. Align with the site to set the strategy & priorities for your teams, ensuring we are working on the right things,
3. Manage your teams by setting & tracking goals and tasks. Continuously improve processes to ensure we are doing it right.
4. Ensure pro-active priority and daily activity management for team & activities (planning communication, team organization, control, checking of the defined targets),
5. Ensure department processes are sufficiently defined and documented. KPIs are implement & monitored, actions are prioritized to ensure KPIs are on target.
6. Communicate pro-actively, consistently, and collaboratively with peers, stakeholders, and partners.
7. Use risk management & scientific assessments to ensure the depth and breadth of resource allocation (people, duration, documentation, etc. ) is commensurate to the risk, impact, and the ROI.
8. Keep up to date with current industry best practices that may give an operational or strategic advantage to the company
9. Accountable for the department budget (OPEX and CAPEX).
10. Accountably for the on time delivery of all QC activities, to ensure overall on time delivery to the clients
11. Review key department documentation, including procedures, reports, deviations, CAPAs, Change controls, etc.
12. Ensure that out of specifications and deviations are appropriately investigated and resolved;
13. Identify and present business cases to continuously improve, increase capabilities & capacities, to better meet client's, mitigate compliance risks, etc.
14. Identify and coordinate continuous improvement & process optimizations within QC and across the site.
15. Responsible for proposing solutions to client's requests, especially where there is a conflict with other department activities.
16. Immediate escalation of client concerns to the project manager and site head
17. Accountable for the planning, execution and tracking of all compliance activities (GxP as well as other regulatory requirements). Including:
18. Accountable for the departments related topics during audits & inspections (including regulatory, compliance, client and corporate)
19. Process definition, and management of documentation (SOPs, Job Descriptions, etc.), ensuring alignment to corporate policies, regulatory requirements and best practices.
20. Training Curriculum definition and on-time completion of training,
21. Follow up, coordination and management of CAPAs, deviations and Change Controls.
22. Lead complex deviation investigations, change management, and critical quality complaint resolution activities.

Profile :

23. University Degree in scientific field
24. 10 years experience in a pharmaceutical company or other related GMP industry.
25. Fluent in French and English
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