QA Sterility Assurance Lead, Visp e/v/e/r/y/o/n/e

ten23 health; Oberwallis; Presencial; CHF 170.000 - 210.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Career development

Flexible working arrangements

Learning culture

Pension plan

Annual bonus

Descripción de la vacante

ten23 health seeks an accomplished Sterility Assurance & Contamination Control Lead to drive our comprehensive contamination control strategy in sterile manufacturing. You will be a recognized expert in GMP-regulated sterile environments, ensuring top quality and regulatory compliance across the site.

Responsibilities include designing, implementing, and continuously improving a robust CCS, leading sterility investigations, and overseeing aseptic qualification programs, operator training, and

Formación

• Proven extensive experience in GMP-regulated sterile environments.
• Leadership in designing and implementing contamination control strategies.
• Strong technical background in cleanroom design and qualification.

Responsabilidades

• Lead and continually improve the Contamination Control Strategy across the site.
• Oversee aseptic facilities, qualification, and operation in regulated sterile manufacturing.
• Drive regulatory remediation and investigations into sterility issues and test failures.
• Ensure operator qualification programs and personnel monitoring meet regulatory standards.
• Support tech transfer, facility startup, and process validation with sterility considerations.
• Conduct risk assessments (FMEA, HACCP) to identify microbial risks and preventive actions.
• Prepare for and manage regulatory inspections and client audits regarding sterility.

Conocimientos

GMP-regulated sterile manufacturing

Contamination Control Strategies

Cleanroom design

Aseptic technique

Aseptic qualification programs

Regulatory inspections readiness

Risk assessments (FMEA, HACCP)

Environmental monitoring programs

Descripción del empleo

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!