Sterility Assurance Lead

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Position Summary:

The Sterility Assurance (SA) Lead role is charged with championing 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 and define the systems listed as key responsibilities (80%). The role is an integral part of a matrix SA organization both within the site and across the different sterile sites, and is charged with adopting and harmonizing aseptic practices at all sites within the network (20%).

DESCRIPTION:

•   Generate and maintain the contamination control strategy.

•   Promote understanding of and compliance to SA-related regulations such as EU Annex 1 and the FDA aseptic processing guide.

•   Implement regular GEMBA-style assessments of the aseptic process on site to assess compliance, identify improvements and provide real-time coaching to aseptic staff.

•   Define, oversee and improve the EM and APS programs.

•   Ensure suitable aseptic comportment, training and oversight programs are in place and effective for aseptic operators and the first-line managers/quality staff overseeing aseptic manufacturing.

•   Ensure that all sterilization processes are being managed compliantly.

•   Conduct risk assessments and improvement programs to maintain SA practices aligned with current and future regulatory expectations.

•   Lead major investigations into issues impacting SA, including adverse EM trends and media fill failures.

•   Review and approve any major/critical deviation and any change proposals with SA impact.

•   Stay up to date with best practice and share that knowledge; approximately 10% of time should be devoted to this.

•   Act as SA subject matter expert with regulators and clients, including as a key part of major audits.

•   Act as SA subject matter expert for new product introduction and applicable capital projects, including new lines and processes.

•   Implement best practice, including ensuring understanding of and compliance with SA-related regulations and guidance, owning transitions and related risk assessments.

•   Report status of and promote Sterility Assurance within the Senior Leadership Team.

•   Audit other sterile sites and suppliers providing microbiological service or sterile materials, as required.

•   Act as the backup for SA lead(s) assigned to other business units on site.

•   Actively represent the site/business unit within the SA Working Group, harmonizing practices across sites in the network.

•   Participate in SA audits at other sites in the network, as required.

•   Act as the lead for the group as a potential future development opportunity for all SA leads.

REQUIREMENTS:

•   Minimum science-based degree in Chemistry, Pharmacy or Microbiology.

•   Substantial experience working in a pharmaceutical Quality department on a sterile site, with deep understanding and proven application of cGMP regulations and international guidelines in a sterile production setting.

•   Clear decision-making and 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.

•   Understanding of 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.

•   Eligibility to act as a Qualified Person as defined in 2001/83/EC and 2001/82/EC, as amended, is preferable but not essential.

•   Strong working knowledge of the principles and guidelines for GMP as set out in the Orange Guide, Eudralex Volume 4, U.S. 21 CFR Parts 210/211 and other relevant regulations.

•   Not afraid to make decisions for the group; holds self and others accountable in achieving goals.

•   Proven track record of developing and leading a high-performance team.

•   Strong leadership skills with good collaboration, communication and problem-solving skills.

•   Excellent written and verbal communication skills to internal and external stakeholders.

•   Natural curiosity to understand systems and processes and willingness to learn.

•   Ability to work in a fast-paced, matrix environment.

•   Capable of working to deadlines and prioritizing multiple tasks.

•   Flexibility to meet changing needs and priorities of the business.

•   Experience of developing and influencing business strategy is desirable.