QA Sterility Assurance Lead

Ten23 Health; Oberwallis; On-site; CHF 180,000 - 240,000; Full time

Benefits offered by this job

Pension plan

Annual bonus

Training & development

Flexible working arrangements

Job summary

ten23 health is seeking an accomplished Sterility Assurance & Contamination Control Lead to guide our containment program in sterile manufacturing. You will drive the CCS design, oversee aseptic processes, and prepare for regulatory inspections to ensure product quality and compliance.

You will lead complex investigations, supervise operator qualification, and collaborate across functions to mitigate microbial risks throughout the product lifecycle.

Qualifications

• Extensive experience in GMP-regulated sterile manufacturing.
• Design and implement Contamination Control Strategies.
• Strong cleanroom design, qualification, and control expertise.
• Experience with regulatory remediation in sterile manufacturing.
• Proven leadership in sterility assurance investigations.
• Aseptic operator qualification and training knowledge.
• Experience with tech transfer, facility startup and process validation.
• Cross-functional risk assessments (FMEA, HACCP) experience.
• Ability to analyze trending data and drive preventive actions.

Responsibilities

• Lead and implement the Contamination Control Strategy aligned with EU GMP Annex 1.
• Manage site-wide sterility assurance strategy across operations.
• Oversee aseptic processes, cleanroom qualification, HVAC systems.
• Lead investigations of sterility events and test failures.
• Coordinate operator qualification programs and training.
• Prepare for regulatory inspections and client audits.
• Collaborate on risk assessments across functions.
• Drive continuous improvement in contamination control.

Skills

GMP Sterile

Leadership

Contamination Control

Regulatory Compliance

Aseptic Processing

Cleanroom Design

Job description

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.

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

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.

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.