Sterility Assurance Business Partner Cmo/third Party
il y a 1 semaine
Site Name:
Belgium-Wavre, GSK House
Posted Date:
May
Sterility Assurance Business Partner CMO/Third Party:
As a
Sterility Assurance Business Partner CMO/Third Party, you will play a key role and will be a member of GSK Global QA Vaccines Business Unit.
Sterility Assurance Business Partner is a Sterility Assurance Center of Excellence (StACE) staff member who is assigned as a Sterility Assurance main point of contact to a specific CMO/third Party GIO/Q department (Operational, Engineering, MSAT, QC) and to CMO/Third Party R&D/TRD.
The main duty is to facilitate interaction between Quality and the departments for implementation of QMS standards, continuous improvement including trending of KPIs and development of capabilities in sterility assurance domains.
The Sterility Assurance Business Partner is a critical position to embed GSK Vaccine sterility assurance strategy into the CMO/Third party operations.
Also, the business partner is key to ensure that future processes and vaccines will be developed to assure sterility by design.
In the context of high pressure from regulatory agencies on sterility assurance issues, the position of Sterility Assurance Business Partner is strategic for ensuring proactive installation of appropriate sterility assurance standards (QMS and standard work) in the business and operations.
Due to the global reach of this role, it will ideally be based in Belgium or UK. Other European locations will be considered. Flexible working is available, travel (up to 40%) may be required.
_ Key responsibilities:
_
- Facilitate interactions between StACE and the CMO/Third party by establishing working relationship (SLA using KPIs) with the leaders and main contact people.
- Act as a main point of contact for the CMO/Third party in supporting the implementation of GSK Sterility Assurance Strategy.
- Is the point of contact for supporting the CMO/Third party in the establishment of the annual Sterility Assurance Plan (StAP) or Sterility Assurance Road map.
- Support CMO/Third party in the execution of the annual StAP in the different sterility assurance domains and processes (training, trouble shooting, coaching/mentoring, specific projects).
- Partnership with CMO/Third party for KPIs analysis, trending and escalation, gap assessment versus standards including (Sterility Assurance GQP's, FDA Guidance, etc.).
- Review with the CMO/Third party the annual performance in Sterility Assurance and help on the preparation of the next StAP.
- Assure availability of Sterility Assurance experts for supporting CMO/Third party in a specific domain according to annual StAP priorities.
- Be the Sterility Assurance quality generalist and therefore act as SPOC in case of issue/question raised by the CMO/Third party.
- External advocacy: Lead or influence proactively Sterility assurance external trade associations.
- Risk management.
_ Why you?_
- BS Degree e.g. Microbiology, Biochemistry, Bioengineering, Pharmacy, Food aseptic production or related discipline. Ph.
- 10 years+ of progressive experience in aseptic or bioburden control manufacturing environment (production, QA, validation) with demonstrated successful results, preferably in FDA regulated environment.
- Previous global/regional function and experience in major organization are preferred.
- Significantly influence, challenge and educate the leadership teams in sterility assurance to optimize Vaccines operations.
- Personal credibility, confidence and robustness to drive and influence senior colleagues.
- Ability to make persuasive recommendations based on rationale analysis.
- Able to network internally (Medicines included) and externally and to communicate to a wide base of partners.
- Strong verbal and written English language skills. French is a plus.
- Coaching and mentoring capabilities for shopfloor training and education.
- In depth knowledge of regulations, guidance, best practices and industry standards related to sterility assurance (for example: GSK, GMP, WHO, PDA, ASTM, ISPE, PhRMA, etc.) including review of regulatory files.
- Strong technical and quality skills in sterility assurance issue.
- Strong capability to work in matrix organization inside StACE team and outside in GSK networks.
- Resilience, capacity for adapting in different environment and resistance to pressure.
- Demonstrated leadership and management skills in matrix organisation.
- Excellent negotiation, decision making and problemsolving skills.
- Continually seeks improvement.
- An analytical mindset (essential).
- Cultural sensitivity.
- Willingness to travel.
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