Sterility Assurance Manager

When you're part of Thermo Fisher Scientific, you'll do challenging work, and be part of a team that values performance, quality and innovation. With revenues of $24 billion and the largest investment in R&D in the industry, we give our people the resources and chances to define meaningful contributions to the world!

At our site in Swindon, Thermo Fisher are forging partnerships that are redefining the industry, crafting new business models between pharma companies and their pharma service providers. We offer groundbreaking solutions that are driven by client needs.

The role:

The Sterility Assurance (SA) Manager is responsible for fostering SA principles across site. This specific role is to be the single person accountable for sterility assurance within the aligned business unit and will own/promote/define the systems listed as key responsibilities (80%). The role is an integral part of the matrix SA organisation both within the site and across the different sterile sites as is charged with embracing and harmonizing aseptic practices at all sites within the network (20%).

• Generate and maintain the contamination control strategy
• Promote understanding of and compliance to SA regulations such as EU Annex 1 & the FDA's aseptic processing guide.
• Implement regular GEMBA style assessments of the aseptic process on site to assess compliance, identify improvements and provide real time mentoring to aseptic staff
• Define, coordinate and improve the EM & APS programs.
• Ensure that suitable aseptic comportment/training/oversight programs are in place and effective. The programs should cover aseptic operators and the first line managers/quality staff charged with coordinating aseptic manufacturing. It should be appropriate to the SA related tasks each person conducts.
• Ensure that all sterilisation processes are being managed compliantly
• Conduct risk assessments and improvement programs to maintain SA practices stay aligned with current and future regulatory expectations.
• Lead major investigations into issue impacting SA (i.e. Adverse EM trends, media fill failures)
• Review & approve any major/critical deviation and any change proposals with SA impact.
• Stay up to date with best practice and sharing that knowledge (10% of time should be devoted to this)
• Act as SA SME for the above with regulators / clients (i.e. key part of major audits)
• Be the SME for new product introduction and for applicable capital projects (i.e. new lines/processes)
• Implementing standard methodology (e.g. ensuring understanding / compliance with SA related regulations & mentorship - owning the transition and any risk assessments we need.
• Report status of and promote SA within the Senior Leadership Team
• Audit other sterile sites and suppliers providing microbiological service or sterile materials (as required)
• Actively represent the site/business unit within the SA Working Group actively harmonizing practices across sites in the network.
• Participate in SA audits at other sites (as required)

Who are we looking for?

• Minimum Science based degree in Chemistry, Pharmacy or Microbiology
• Substantial experience working in a pharmaceutical Quality department on a sterile site. This position requires deep understanding and proven application of cGMP regulations and international guidelines in a sterile production setting. This knowledge needs to be combined with clear decision making, pragmatism aligned with quality risk management principles to demonstrate release of product appropriate for commercial use.
• Substantial Quality Assurance experience and 'hands-on' knowledge of all Quality Systems required for a sterile manufacturing facility.
• Understands the principles of sterile manufacturing.
• Demonstrated ability to make sound decisions regarding evaluation of GMP compliance, and leadership abilities in the management of QA oversight
• Eligible to act as a 'Qualified Person' as defined in 2001/83/EC and 2001/82/EC (as amended), is preferable but not essential
• Solid understanding of the principles and guidelines for GMP as set out in the Orange Guide, Eudralex Volume 4, U.S. 21CFR part 210/211 and other relevant regulations
• Is not afraid to make decisions for the group. Holds self and others accountable in achieving goals
• Strong leadership skills with good collaboration, communication and problem-solving skills.
• Excellent written and verbal communication skills to internal and external partners with a desire to learn and have a natural curiosity to understand systems and processes
• Ability to work in a fast paced, matrix environment and deliver deadlines and prioritise multiple tasks
• Flexibility to meet changing needs and priorities of the business with experience of developing and influencing business strategy

What's in it for you:

Competitive base salary, Annual bonus, Free on-site car parking, Contributory Pension, Private medical insurance and additional Flexible benefits

About us:

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving sophisticated analytical challenges, improving patient diagnostics and therapies or growing efficiency in their laboratories, we are here to support them.

Our global team of more than 75,000 colleagues delivers an outstanding combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon

With Thermo Fisher Scientific, it's not just a career. It's a chance to realise your best - professionally and personally.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, colour, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Apply today! http://jobs.thermofisher.com