QA Sterility Assurance Specialist; f​/m​/d

QA Sterility Assurance Specialist (f/m/d) page is loaded## QA Sterility Assurance Specialist (f/m/d) remote type:
Hybrid (remote and on-site) locations:
Berntime type:
Full time posted on:
Posted Todayjob requisition :
JR101072
** Boost our team
** You will join a collaborative Quality Assurance organization led by the Director QA Bern, Qualified Person (FVP) and composed of three teams, each united by a shared mission to deliver excellence and safeguard patient health every day.

As a QA Sterility Assurance Specialist (f/m/d), you will work closely with Production, Operations, MSAT, and internal QA teams, providing guidance and hands-on support for aseptic processes and contamination control. You will be dedicated to compliance, proactively identifying improvements, and shaping the contamination control strategy as we launch new aseptic products.

You will report directly to the Director QA Bern, Qualified Person (FVP), and be based in our manufacturing site in Bern (eligibility to work in Switzerland is required). The position offers a hybrid work model with the flexibility to work from home 1–2 days per week, depending on business and production needs.
** About the role
** You will be the QA subject matter expert for sterility assurance, working directly the production environment to understand field needs and drive best practices in aseptic manufacturing. You will develop, implement, and maintain strategies to ensure sterility and contamination control in cleanroom operations and aseptic procedures. Your responsibilities will include:
* Developing and maintaining sterility assurance and contamination control strategies for aseptic processing
* Leading risk assessments for aseptic process, single use systems and critical interventions, and ensuring compliance with authorities relevant Guidance such as Annex 1
* Lead deviations, root cause analyses, CAPA, and efficiency checks for sterility-related issues (bioburden, endotoxin, EM)
* Providing training and coaching on aseptic and sterility best practices, including setting up training for the coming years
* Mentor operations and QA staff to reinforce contamination control culture and right-first-time behaviours
* Staying updated on regulatory developments and updating procedures as needed
** Your skills and qualifications
*** Bachelor’s or Master’s degree in Microbiology, Biology, Pharmacy, or a related scientific field
* Minimum 5 years’ experience in GMP biologics or sterile manufacturing, including 2+ years in QA sterility/aseptic leadership
* Strong background in sterility assurance or quality management within GMP-regulated environments, with expertise in aseptic processing, EM, sterilization validation, and contamination control
* Demonstrated experience in investigations (root cause analysis), CAPA, risk management, and audit interactions
* Excellent communication, collaboration, and decision-making skills under time-sensitive conditions
* Analytical, detail-oriented, and skilled in risk-based problem solving with a continuous improvement mindset
* Full professional proficiency in English; basic German is an advantage
** Who you are
** You are a proactive problem-solver with strong communication skills, able to navigate between teams and bring new ideas to the table. You are solution-oriented, not afraid to take initiative, and thrive in a collaborative environment. You are ready to shape the contamination control strategy and contribute to the success of our aseptic product launches.
** What we offer
** This role lets you drive innovation and shape contamination control strategy for new aseptic products. You'll gain strong organizational visibility and have the opportunity to define this position. Join us to make a meaningful impact.

Please complete the application form using the “Apply” link. We are interviewing on an ongoing basis and look forward to receiving your CV as soon as possible. It is not mandatory to send a cover letter. Applications submitted via email will not be considered.

Join us and become part of a diverse team dedicated to making a difference together. We kindly request that head-hunters or recruitment agencies refrain from contacting us…