Overview
Job Summary:
This position is accountable for the integration of New Product Introductions, NPI, within QC at the site of STA Pharmaceutical Switzerland SA.
Accountable for the project management and on time delivery of NPI within QC, including method transfer / validation, analytical testing of incoming materials, packaging components, in-process testing, drug product & drug substance release testing and stability testing, as well as equipment cleaning residual testing, for technical, registration and clinical batches.
As the main point of contact between the client and QC activities, you will be focused on the customers’ needs. You will mentor and coach your team, creating a strong team spirit. Using your significant experience, you will streamline QC processes and implement efficiencies.
You are accountable for the processes under your responsibility as well as ensuring your staff follows them. You will continuously improve processes to ensure they remain in compliance with cGMP, EHS and best practices. This includes investigations, CAPA and change controls.
This position is a leadership role for the QC department and a role model for WuXi values and competencies.
Responsibilities
Essential Job Functions:
1. Accountable for the project management and on-time completion of NPI client QC activities, including associated documentation
2. Accountable for the end-to-end coordination of your team’s daily operations, including planning, task allocation, progress monitoring, and cross-functional communication.
3. This includes accountability for the timely completion of associated activities (to ensure on time NPI QC activities), including sampling, consumable, equipment & instrument availability, documentation (procedures, methods) are available, packaging component testing, stability,
Hence you will closely work with your QC peers & other departments to coordinate activities
4. Responsible to review and update the capacity / resources planning, support the department head to plan sufficient equipment & personnel for the following 6-12 months
5. Accountable for meeting clients’ expectations and needs
6. Main point of contact between the client and QC activities
7. Proactive & appropriately communicate
8. Making yourself available: during on-site visits as well as promptly replying to requests
9. Track project timelines, adjusting resources so that timelines remain on track, escalating when needed
10. Client focused, you will find solutions to complex problems by collecting information and understanding facts to identify issues in the lab, draw correct and valid conclusions. Apply risk management tools to make decisions.
11. Responsible that your team follows cGMP compliance and data integrity, by ensuring documentation is continuously improved to ensure clarity and ease of use
12. Activities are performed as per the procedure
13. Activities are documented as per the procedure
14. Responsible for continuing the high performance of your team
15. Provides technical guidance and support to team members
16. Ensures continuous professional development and guidance to direct reports
17. Training Curriculum definition and on-time completion of training,
18. Manage performance, lead and develop team members
19. Team member backups and succession plans
20. Responsible for leading OOX results laboratory investigation and deviation investigation, perform impact assessment and establish corrective actions & preventive actions (CAPA) based on the root causes. Initiates and manages related change requests to completion
21. Track KPI, adjusting resources so that KPI are on track, escalating when needed
22. Represents department during specific site meetings, as required
23. Back up of peers (QC management), including for specific client or site meetings, team management, etc.
24. Continuously improve the lean lab initiatives such as 5S, deviation reduction, right first time, permanent inspection readiness, visual management
EHS:
Line Managers shall provide a safe and healthy work environment for their staff in areas under their control and shall ensure compliance with relevant rules and legislation in those areas.
25. Identify 1 (or more) members of your department to be part of the site EHS team,
26. Work closely with EHS to evaluate hazards and perform risk analysis,
27. Ensure that staff (including short duration and temporary contracts) are properly informed on hazards, and trained to act in consequence,
28. Promote safe practices and behaviors, verify that EHS rules are implemented and respected.
Report immediately all incidents and near-misses to EHS, participate in investigations and identify preventive measures to prevent similar accidents in the future.
Qualifications
Job Requirements:
Experience / Education
29. Master in chemistry, biochemistry, biology, pharmacy or equivalent
30. >5 years project management of GMP NPI, method transfer & validation
31. Method Development & CMO experience advantageous
Knowledge / Skills / Abilities:
32. Fluent in French and English
33. Demonstrated experience in the project management of OSD method transfer and validation
34. Demonstrated ability to effectively communicate with clients
35. Solid knowledge of analytical technologies and laboratory workflows, such as chromatography techniques (HPLC, UPLC, GC), dissolution, UV, Karl-Fischer, etc.
36. Experienced with laboratory investigation and establishment of corrective and preventive measures, by using scientific risk based techniques, based on data to reduce and control risks
37. Thorough understanding of relevant cGMPs, EHS and regulatory requirements, and their practical application to ensure compliance in the laboratory
38. Strong working knowledge to ensure Quality Control compliance with applicable regulations, including EHS and cGMP
39. Organized and rigorous, able to provide leadership and coaching to the QC team in order to maintain an environment of trust and personal accountability