Sterility Assurance Manager

Job Description

Mission of function

Production of biopharmaceutical products conform to the requirement of international quality defined by the FDA, the EMEA, the ICH, etc.

The sterility Assurance Lead (SAL) role is charged with encouraging good SA practices across site. This role is to be the single person leading sterility assurance within the aligned business unit and will own/promote/define the systems listed as key responsibilities (80%). The role is also an integral part of a matrix SA organization both within the site and across the different sterile sites within the network as is charged with embracing and harmonizing best aseptic practice (20%).

Context of position and function

• The site is a biopharmaceutical multi-product and multi-client's site with development and producing facilities of pharmaceutical products for both clinical trials (phase I, II and III) and commercial applications.
• This type of facility needs to be conformed to the rules et regulation of the BPF established by the ministers of health and the social protection of countries, as well as the international directives.
• The production activities need to be driven in an effective and efficient way to guarantee the global competitiveness of the sites. Besides, due to the very high value of the intermediate products and products, the production activities need to be driven in a highly controlled way.
• The control of the production activities and the rules, regulation and cGMP directives compliance are needed for the client's products adequation and the site operating license. The principal contacts are within its own department.
• Content of the function

• Generate and maintain the contamination control strategy
• Promote understanding of and compliance to SA related regulations such as EU Annex 1 & the FDA's aseptic processing guide.
• Conduct 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 where necessary 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 and must be appropriate to the SA related tasks each person conducts. The Sterility Assurance Lead is the main trainer for subjects linked to SA like cleaning, gowning, EM, etc. on site.
• Ensure that all sterilization processes are being handled compliantly.
• Conduct risk assessments and improvement programs to ensure that SA practices stay aligned with current and future regulatory expectations.
• Lead major investigations into issues 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 practices and actively share that knowledge.
• Act as SA SME for the above with regulators/clients (i.e. key part of major audits)
• Act as SA SME for new product introduction and for applicable capital projects (i.e. new lines/processes)
• Implementing best practice (e.g. ensuring understanding/compliance with SA related regulations & guidance - owning the transition and any risk assessments we need.
• Report status of and promote Sterility Assurance within the Senior Leadership Team (lead)
• 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 sites

• 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 in the network (as required)
• Act as the lead for the group (potential future development opportunity for all SA leads)

• Understand and ensure implementation of emergency procedures and safe systems of work
• Ensure compliance with environment, health, and safety rules, signage, and instructions at all times
• Ensure timely reporting and investigation of all accidents, near misses, and breaches of rules.

• Support and active participation to the audits and inspections

• Ability to work in a fast-paced, matrix environment essential
• Capable of working to deadlines and prioritize multiple tasks
• Strong leadership skills with good teamwork, communication and problem-solving skills.

• Minimum Science-based degree in Microbiology
• Meaningful experience, between 5-10 years working in or directly supporting manufacturing within a sterile pharmaceutical manufacturing site. This position requires a deep understanding of sterile product manufacture and good aseptic practices. This knowledge needs to be combined with quality risk management principles.
• Strong working knowledge of the principles and guidelines for GMP as set out in the Eudralex Volume 4, U.S. 21CFR part 210/211 and able to operate as a subject matter expert on regulations pertaining to aseptic manufacturing such as EU Annex 1 and the FDA aseptic processing guide.
• Is not afraid to make decisions. Holds self and others accountable in achieving goals.
• Excellent written and verbal communication skills to internal and external stakeholders
• Wants to learn and have a natural curiosity to understand systems and processes
• Flexibility to meet changing needs and priorities of the business
• Experience of developing and influencing business strategy is desirable