QA Sterility Assurance Lead, Visp

Ten23 Health; Oberwallis; Remote; CHF 190,000 - 230,000; Full time

Benefits offered by this job

Flexible working arrangements

Competitive pension fund

Annual bonus

Training & development options

Job summary

ten23 health is seeking an accomplished Sterility Assurance & Contamination Control Lead to guide the CCS strategy for our GMP-regulated sterile manufacturing operations. You will shape site-wide sterility programs and ensure compliance with EU GMP Annex 1 and global regulators.

We are looking for a proven leader with deep aseptic knowledge, cleanroom design expertise, and a track record of remediation and inspection readiness. Join a dynamic team driving patient-safe injectable medicines.

Qualifications

• Proven extensive experience in GMP-regulated sterile manufacturing environments.
• Leadership in designing and implementing contamination control strategies.
• Strong technical background in cleanroom design, qualification and control.
• Experience with regulatory remediation in sterile manufacturing.
• Expertise in leading sterility assurance investigations.

Responsibilities

• Lead the site contamination control strategy (CCS) across sterile operations.
• Design, implement and continuously improve sterility assurance programs aligned with EU GMP Annex 1 and global expectations.
• Oversee aseptic facility design, qualification, and control (HVAC zoning, flows, RABS/isolators).
• Drive regulatory remediation activities and requalification of clean areas when needed.
• Lead investigations of sterility failures, contamination events, and media fill excursions.
• Institute operator qualification, aseptic technique training, gowning, and personnel monitoring programs.
• Support tech transfer, facility startup, and process validation with sterility integrity in mind.
• Perform cross-functional risk assessments (FMEA/HACCP) to mitigate microbial risk.
• Monitor data trends and environmental monitoring to trigger preventive actions.
• Prepare for and support regulatory inspections and client audits.

Skills

GMP sterile manufacturing

Contamination control leadership

Cleanroom design & qualification

Regulatory remediation

Sterility investigations

Operator qualification programs

Risk assessments (FMEA/HACCP)

Data trending & preventive actions

Tools

Environmental monitoring systems

GMP systems

Job description

About Us

ten23 health is a human-centric and sustainable strategic partner of choice for the pharmaceutical industry and biotech start-ups for the development, manufacture, and testing of tomorrow’s medicines. We support our clients in developing differentiated, stable, usable, and safe injectable treatments for patients.

Your mission

We are seeking an accomplished and highly experienced Sterility Assurance & Contamination Control Lead to lead our comprehensive contamination control strategy within our sterile manufacturing operations. The successful candidate will be a recognized expert in GMP-regulated sterile environments, playing a critical role in ensuring the highest standards of product quality and regulatory compliance.

Your responsibilities will include,

• Proven experience in a GMP-regulated sterile manufacturing environment, including for example aseptic processing, terminal sterilization, or advanced therapy productS
• Demonstrated leadership in designing, implementing, and continuously improving a robust, site-wide Contamination Control Strategy (CCS) in alignment with EU GMP Annex 1 and global regulatory expectations (FDA, EMA, MHRA, PIC/S)
• Strong technical background in cleanroom design, qualification, and control, including state-of-the-art aseptic facility builds or major upgrades (HVAC zoning, material/personnel flows, RABS/isolator integration)
• Experience with regulatory remediation in sterile manufacturing - leading or supporting the recovery of compliance status, requalification of clean areas, and system-based corrective actions under regulatory oversight
• Demonstrated expertise in leading and resolving complex sterility assurance investigations: environmental or product contamination events, sterility test failures, media fill excursions, and utility-based contamination
• Deep understanding of aseptic operator qualification programs, aseptic technique training, gowning qualification, and personnel monitoring in controlled environments
• Familiar with quality oversight during tech transfer, facility startup, and process validation phases, ensuring sterility assurance is designed in from the outset
• Strong experience in cross-functional risk assessments (e.g., FMEA, HACCP) to proactively identify and mitigate microbial risks throughout the product lifecycle
• Able to critically assess trending data, EM programs, and facility/utilities performance to anticipate quality issues and drive preventive actions
• Experienced in preparing for and managing regulatory inspections and client audits with a focus on sterility assurance systems, contamination control, and aseptic practices

Your profile

We are looking for someone with:

• Proven extensive experience in a GMP-regulated sterile manufacturing environment.
• Demonstrated leadership in designing and implementing Contamination Control Strategies.
• Strong technical background in cleanroom design, qualification, and control.
• Experience with regulatory remediation in sterile manufacturing.
• Demonstrated expertise in leading and resolving complex sterility assurance investigations.
• Deep understanding of aseptic operator qualification programs and personnel monitoring.
• Familiarity with quality oversight during tech transfer, facility startup, and process validation.
• Strong experience in cross-functional risk assessments.
• Ability to critically assess trending data and drive preventive actions.
• Experienced in preparing for and managing regulatory inspections and client audits.

Why us?

We offer a dynamic environment where you can contribute meaningfully, collaborate with exceptional minds, and unlock your full potential.

Here's what sets ten23 apart:

• A valuable and impactful career development opportunity in an inspiring environment
• Flexible working arrangements and environment with an open culture and diverse workforce
• The opportunity to work with and learn from highly qualified and experienced employees
• Our learning and self-developing culture offers a wide range of training options
• Competitive pension fund plan, annual bonus, and other financial and non-financial benefit

At ten23 we believe in self-responsibility and mutual trust. Therefore, we will provide our employees as much flexibility as possible and limit any bureaucracy to a minimum, whilst ensuring compliance with all applicable laws.

Contact

For more information and clarification, please connect Amrith ([e-mail]) from our Talent team!