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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 earlystage development through to latestage clinical trials including Tox studies and commercial products. This role will be responsible for establishing and implementing phaseappropriate 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 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 ThirdParty 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 longterm goal achievement. Maintains effective Quality governance and builds strong partnerships with site leadership to align on strategic and daytoday 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 decisionmaker 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 managementlevel 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 problemsolving 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 lifechanging healthcare solutions that make a global impact.

Lets build a healthier future together.