Network Head of Quality Cell & Gene Therapy

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections,where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position

A healthier future. Its what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. Thats what makes us Roche.

The Opportunity

The Network Head of Quality Cell & Gene Therapy(PTQC) is responsible for ensuring that cell and gene therapies comply with regulatory requirements and quality standards from early-stage development through to late-stage clinical trials including Tox studies and commercial products. This role will be responsible for establishing and implementing phase-appropriate strategies for IMP products, ensuring tailored approaches that align with the specific requirements and goals at each stage of development for cell and gene therapies. Moreover, this role will be responsible for establishing tailored approaches for the commercial CGT portfolio.The Network Head will serve as a partner to the Head of PTC and will be a standing member of the PTCLT.

The Network Head QC> is accountable for the quality of the clinical and commercial launch products manufactured across the PTC network including the Penzberg, HIT, Poseida and Spark sites and will ensure compliance with valid specifications and cGMP requirements (both clinical and commercial).

As a Network Head of Cell and Gene Therapy quality team leader, you will be providing quality oversight and leading a team of quality professionals (~80 employees including 4 Senior Leaders) while ensuring compliance with regulatory standards.The responsibilities include but are not limited to:

• Ensures manufactured products meet Health Authority regulations, company standards, and expectations. Leads Health Authority inspections, Third-Party audits, and manages timely responses to inspection observations
• Provides leadership, coaching, and guidance to the Quality team. Manages performance and development to achieve organizational and departmental goals, fostering a productive environment and continuous professional growth
• Works with internal business partners to identify and manage Quality and Compliance Risks, ensuring timely communication and resolution. Reports significant quality or regulatory issues to Executive Management, ensuring the right to operate and quality supply to patients are maintained
• Develops and communicates strategies for GMP compliance, continuous improvement, and long-term goal achievement. Maintains effective Quality governance and builds strong partnerships with site leadership to align on strategic and day-to-day priorities
• Provides expert interpretation of QMS requirements for CGTs, supports routine audits, and regularly visits manufacturing and QC areas. Builds a culture of continuous improvement, models lean leadership principles, and serves as the final decision-maker and spokesperson for the Quality Unit

Who you are

• Holds a Bachelors degree in Life Science, Pharmacy, or related field, with a PhD considered an advantage. Has at least 15 years of experience in the Pharma/Biopharmaceutical industry, including 10 years in Quality, Compliance, Regulatory, and/or Validation
• Possesses at least 8 years of management-level experience, demonstrating strong leadership skills, and the ability to direct and lead large, successful organizations
• Has excellent knowledge of US, European, and International cGMP regulations, and QM/QRM techniques, with an ability to interpret and implement quality standards effectively
• Demonstrated experience and knowledge of Quality operations and processes, ideally in the Cell and Gene Therapy area. Proven ability to manage and improve quality operations
• Experienced in handling US, European, and other relevant Health Authority inspections. Exhibits strong collaboration, influencing, problem-solving skills, and the ability to drive positive change

Are you ready to apply? We want someone who thinks beyond the job offered - someone who knows that this position can be an outstanding opportunity to craft the future of Roche.

Who we are

A healthier future drives us to innovate. Together, more than 100000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.