Global Sterility Assurance Director
il y a 3 semaines
**Site Name**: UK - County Durham - Barnard Castle, Belgium-Wavre, Upper Merion, USA - Maryland - Rockville, Ware
**Posted Date**: Nov 21 2024
The Global Sterility Assurance Director at GlaxoSmithKline (GSK) is a pivotal role within the Strategic Product Quality staff, bringing critical expertise in sterility assurance across various initiatives and projects within GSK's internal and external commercial and R&D vaccine and medicine drug substance and drug product manufacturing sites. This role is essential in ensuring that both internal sterility assurance standards and external regulatory standards and guidance are comprehensively understood and effectively applied throughout the organization.
A key responsibility of the Global Sterility Assurance Director is to partner with various teams, including those in Research & Development (R&D), Materials, Science & Technology (MSAT), Quality, and Operations, to ensure that Business Units (BU) as well as contract manufacturing organizations (CMOs) adhere to these stringent standards. The Director also identifies business solutions to enhance aseptic and low bioburden manufacturing processes, aiming to improve robustness and efficiency while building strong internal and external relationships with key stakeholders.
Beyond these responsibilities, the Global Sterility Assurance Director plays a significant role in due diligence activities during onboarding processes, serves as the person in plant (PIP), and supports routine inspection and pre-approval inspection readiness through to filing and product launch. The Director is also involved in resolving ongoing incidents and deviations.
The Global Sterility Assurance Director is a global staff member, acting as the primary point of contact for sterility assurance across all areas of the business, including departments such as Operations, Engineering, MSAT, and Quality Control (QC), as well as CMOs and third-party R&D/Technical Research and Development (TRD). The main duty of this role is to facilitate interaction between Quality and various sites or departments for the implementation of Quality Management System (QMS) standards and continuous improvement initiatives, including KPI trending and capability development in sterility assurance domains and process confirmations. This position is crucial for embedding GSK's sterility assurance strategy into specific operations and ensuring that future processes and products are developed with sterility by design. Given the high pressure from regulatory agencies on sterility assurance issues, the role is strategic for ensuring the proactive installation of appropriate sterility assurance standards (QMS and standard work) across the business and operations. Additionally, the Director plays a central role in remediation plans following any regulatory observations, making it a highly strategic and impactful position within the organization.
**Key Responsibilities**:
- Facilitate interactions between Global sterility assurance and the business units under its responsibility by establishing working relationship (Service Level agreement using Key Performance Indicators) with the leaders and main contact people.
- Act as a main point of contact for the Business units in supporting the implementation of GSK Sterility Assurance Strategy
- Is the point of contact for supporting the business units in the establishment of the annual Contamination Control Strategy or Sterility Assurance Road map
- Support Business units in the execution of the annual CCS in the different sterility assurance domains and processes (training, trouble shooting, coaching/mentoring, specific projects) and perform process confirmations on targeted topics
- Partnership with business units for Key Performance Indicators analysis, trending and escalation, gap assessment versus standards including (Sterility Assurance GQP's and QMS, FDA Guidance, etc.)
- Review with business units the annual performance in Sterility Assurance and help on the preparation of the next CCS
- Assure availability of Sterility Assurance experts for supporting Business units in a specific domain according to annual CCS priorities.
- Is the Sterility Assurance quality generalist and therefore act as SPOC 9Single Point of Contact) in case of issue/question raised by the Business units.
- External advocacy: Lead or influence proactively Sterility assurance external trade associations.
- Developing Capability: Supporting the development of sterility assurance capability across key areas of the business through delivery of training, coaching and mentoring.
**Why you?**:
**Basic Qualifications**:
We are looking for professionals with these required skills to achieve our goals:
- Bachelor degree in a Scientific Discipline
- Significant experience in aseptic or bioburden control manufacturing environment (production, QA, validation) with demonstrated successful results, preferably in FDA regulated environment
- In depth knowledge of regulati
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