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As a key player in the operations, the QA Sterility Assurance Manager will provide vital support and expertise to ensure the highest sterility assurance standards are upheld. By overseeing processes such as Aseptic Practices, Environmental Monitoring, Cleaning and Sanitization, Sterilization, and Media Fill, you will help deliver safe, high-quality products to patients efficiently.

You will serve as the go-to expert for sterility assurance at the site, collaborating with a network of professionals to continuously improve and harmonize practices across the GSK Supply Chain.

As a member of the Quality Leadership team, you will share responsibility for achieving our quality performance targets, regulatory compliance, and cost efficiency. You will also ensure that your personal and team's objectives align with our overall Quality, Site, and B&D goals.

In this role, YOU will…

Sterility Assurance

• Be the key contact for the Site for all matters related to Sterility Assurance including Aseptic Practices, Environmental monitoring, for clean rooms (viable and non viable) operators and critical utilities, Surface Cleaning and Sanitization, Sterilization, Media Fill and Sterility Failures: provides expert support to production and QA

• Assure the adequate facilities contamination control practices monitoring tools are provided to Production to guarantee the best environmental monitoring indicators levels

• Put in place and lead specific task forces to solve technical issues in close collaboration with the shared service sterility assurance

• Guarantee the maintenance of the cGMPs in the area of responsibility (SOP, documentation, audits, training, method validation)

Quality / Regulatory / EHS

• Ensure compliance to local and international standards, cCMP, Regulatory requirements and all GSK Quality Management Systems (QMS) policies and procedures as applicable as well as adherence to the Environmental, Health and Safety rules.

People & Organization

• Ensure optimal staffing levels and competencies are in place and ensure the retention, engagement and development of talent within the organization

• As a leader, personally role models and develops the team towards high performance behaviours Engages the team to deliver the GSK objectives

Financial

• Assists in resource and budget planning for the area of expertise

Change and continuous improvement

• Provide quality environment and leadership for change initiatives in the area of expertise which contribute to the overall effective improvement of Parma manufacturing and supply

• Build lean six sigma expertise across team to ensure continuous improvement

Representation

• Represent quality during external regulatory audits in specific area of responsibility as require

Why YOU?

Qualifications & Skills:

• Master’s degree in Sciences (Bio Engineering, Biology, Biotechnology, Pharmacology, …) or equivalent experience

• Proven professional experience in the pharmaceutical / biotech / medical device / food industry or equivalent environment including  several years  of proven aseptic manufacturing and microbiology experience

• Good Interpersonal and people management skills with demonstrated engaging, empowering and decisive leadership style and well developed relation building skills to gain trust and credibility and to build a great place to work and good social climate within the team

• Direct experience with GxP regulated environment within a major jurisdiction

• Good knowledge of FDA/EU/ICH guidelines and inspections

• Strong analytical and problem solving (trouble shooting) skills and flexible thinking capability

• Continuous improvement focus – ability to challenge the status quo

• Effective influencing skills – abili