City : 2323 duParc Technologique Blvd

Category : Other

Industry : Healthcare

Employer : GSK

Job purpose:

Sterility Assurance Business Partner is a Sterility Assurance Center of Excellence (StACE) staff member,  part of the Vaccine Global Quality Organization who is acting as Sterility Assurance main point of contact for multiple strategic departments (three operational regions including 20 manufacturing production units, Engineering, Manufacturing Science and Technology, QC) and  R&D.

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 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. The position of Sterility Assurance Business Partner is also central in remediation plans following regulatory observations.

Key responsibilities:

• Facilitate interactions between StACE and the department/site by establishing working relationship (SLA using KPIs) with the leaders and main contact people.
• Act as a main point of contact for the department/site in supporting the implementation of GSK Sterility Assurance Strategy
• Is the point of contact for supporting the department/site in the establishment of the annual Sterility Assurance Plan (StAP)
• Support department/site in the execution of the annual StAP in the different sterility assurance domains and processes (training, trouble shooting, coaching/mentoring, specific projects)
• Partnership with department/site for KPIs analysis, trending and escalation, gap assessment versus standards including (Sterility Assurance GQP's , FDA Guidance, etc.)
• Review with the department/site the annual performance in Sterility Assurance and help on the preparation of the next StAP
• Assure availability of Sterility Assurance experts for supporting department/site in a specific domain according to annual StAP priorities.
• Accountable for alignment in way of working and standard works between department and sites in Sterility Assurance subjects.
• Is the Sterility Assurance quality generalist and therefore act as SPOC in case of issue/question raised by the department/site.
• External advocacy:  Lead or influence proactively Sterility assurance external trade associations.

Why you? 

Key Requirements: 

• Bachelor degree with a minimum of 10 years’ experience in aseptic manufacturing (operation, QA, validation)
• Ph.D., MS, Bio-engineer, Pharmacist in Microbiology, Biochemistry, Bio-engineering, Pharmacy, Food aseptic production
• Complexity of sterility assurance concepts in a complex matrix organization in a highly regulated  environment
• 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 (PSC included) and externally and to communicate to a wide base of partners
• Strong verbal and written English language skills
• 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 

*LI-GSK

If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.

Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.

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