We're expanding our capabilities, and we need someone with deep expertise in aseptic operations, isolator technologies, and leading cross-functional teams through major capital projects. If you're driven by the challenge of bringing a new manufacturing line to life while ensuring "right first time" quality, this role is for you. Join us and help shape our new chapter.
Your responsibilities will include,

• Proven QA leadership experience in a GMP-regulated sterile manufacturing environment, with direct oversight of aseptic operations, isolator-based technologies, and sterile drug product filling.
• Demonstrated experience supporting major capital projects and facility expansions, specifically the installation qualification, operational qualification, and startup of new sterile manufacturing equipment and filling lines.
• Strong technical expertise in isolator technologies (design, qualification, and aseptic behaviors), including knowledge of decontamination cycles, transfer systems, and integration with filling and lyophilization operations.
• Experience in validation oversight: process validation, cleaning validation, aseptic process simulations (media fills), and equipment qualification activities.
• Solid background in contamination control strategy and environmental monitoring program design, ensuring compliance with Annex 1, FDA, EMA, and PIC/S expectations for isolator-based operations.
• Skilled in regulatory and client audit preparation, with ability to represent QA and operations readiness during inspections of new facilities/startups.
• Hands-on experience with tech transfer and batch release readiness during new facility qualification, ensuring compliance without delaying project milestones.
• Strong knowledge of quality risk management principles (ICH Q9) and ability to apply them to new line startup activities, balancing compliance and operational execution.

We are looking for someone with:

• Demonstrated ability to lead QA operations through large-scale expansion projects, aligning quality requirements with engineering, validation, and manufacturing timelines.
• Proven success in building cross-functional collaboration with engineering, validation, QC, manufacturing, and project management teams to ensure a “right first time” approach to startup.
• Strong leadership in change management, helping teams adapt to new technologies, isolator operations, and new ways of working.
• Creates an environment where compliance and project delivery are balanced — ensuring timelines are met without compromising quality standards.
• Coaches and develops QA professionals to become trusted partners during new facility qualification and startup.
• Capable of engaging effectively at all levels: shop floor, project team, site leadership, and external stakeholders (clients, regulators, suppliers).
• Highly effective communicator, able to influence decision-making and ensure quality is embedded in every stage of the expansion.
• Analytical and decisive — able to review complex data packages (qualification, validation, EM trending, media fills) and make timely, risk-based QA decisions.

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.

For more information and clarification, please connect Amrith (amrith.kiran@ten23.health) from our Talent team!