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The Position
A healthier future. It’s 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. That’s 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 :
* Ensuring manufactured products meet Health Authority regulations, company standards, and expectations. Leading Health Authority inspections, Third-Party audits, and managing timely responses to inspection observations.
* Providing leadership, coaching, and guidance to the Quality team. Managing performance and development to achieve organizational and departmental goals, fostering a productive environment and continuous professional growth.
* Working with internal business partners to identify and manage Quality and Compliance Risks, ensuring timely communication and resolution. Reporting significant quality or regulatory issues to Executive Management, ensuring the right to operate and quality supply to patients are maintained.
* Developing and communicating strategies for GMP compliance, continuous improvement, and long-term goal achievement. Maintaining effective Quality governance and building strong partnerships with site leadership to align on strategic and day-to-day priorities.
* Providing expert interpretation of QMS requirements for CGTs, supporting routine audits, and regularly visiting manufacturing and QC areas. Building a culture of continuous improvement, modeling lean leadership principles, and serving as the final decision-maker and spokesperson for the Quality Unit.
Who you are
* Holds a Bachelor’s 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 100,000 employees across the globe are dedicated to advancing 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.
Let’s build a healthier future, together.
Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 10,700 employees from over 100 countries come together at our Basel / Kaiseraugst site, which is one of Roche's largest sites.
Besides extensive development and training opportunities, we offer flexible working options, 18 weeks of maternity leave and 10 weeks of gender-independent partnership leave. Our employees also benefit from multiple services on site such as child-care facilities, medical services, restaurants, and cafeterias, as well as various employee events.
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