ERP Program Quality & Compliance Quality Lead (m/f/d)

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The Position

Join Our Team as the ERP Program Quality & Compliance Quality Lead. Are you a visionary architect with grit? Do you have a passion for ensuring quality and compliance in complex programs? If so, we want you to join our exciting Digital Quality and Compliance Chapter in Roche Pharma Technical Operations.

As the ERP Program Quality & Compliance Quality Lead, you will be pivotal in shaping, implementing, and maintaining the Quality & Compliance Framework for the ASPIRE Program and later ERP implementations. Your expertise will be crucial in covering product development and deployment to manufacturing sites and commercial affiliates, ensuring that everything we produce meets the highest legal, regulatory, and Roche internal quality standards.

You will report directly to the Chapter Lead of Digital Quality and Compliance in PTQ and serve the ASPIRE Program in a matrix structure.

Career Opportunities

• Set up and maintain the Quality & Compliance Framework according to applicable requirements and standards and ensure adherence to GxP and other industry-related compliance obligations in design and deployment

• Align quality roles across program levels and business areas, providing critical input and oversight

• Develop and implement quality management processes for change management, discrepancy investigation/CAPA management, risk management, and documentation

• Align quality management processes with agile product development timelines (SAFe)

• Oversee key program documentation, including policies and procedures

• Support internal and external audits and inspections, ensuring inspection readiness

• Provide consultation and support for local ASPIRE QA/Compliance leads during all Deployment Gate Reviews

Qualifications & Experience

• Proven experience in quality and compliance roles within the pharmaceutical industry with a strong understanding of GxP, CSV, ICH, and related quality standards

• Degree in Science, Engineering, and/or Business, along with proven expertise in the SAFe Framework and Quality Risk Management

• Excellent leadership, communication, and organizational skills, with the ability to work collaboratively in a matrixed environment and with diverse teams

• Interest in indirect leadership with the ability to influence without authority, motivating and leading cross-functional teams across the enterprise

• Strategic agility and business acumen, including finance, strategic planning, process management, and organizational development, with a willingness to travel 10% internationally

We would love to hear from you if you are ready to embrace a new challenge and make a significant impact! Apply today and join us in delivering compliant products that make a difference.

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.

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

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. Read more .

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.

We believe in the power of diversity and inclusion, and strive to identify and create opportunities that enable all people to bring their unique selves to Roche.