Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.

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. Crafting a world where we all have more time with the people we love. That’s what makes us Roche!

The Opportunity:

Quality is a competitive advantage for Roche/Genentech. It allows us to deliver high-quality products to patients, ensures our right to operate, and helps us bring value through process excellence and continual improvement efforts. Our philosophy – which permeates across the entire Pharmaceutical Technical Operations organization – is that quality is every patient’s right and every employee’s responsibility. 

The Quality Site Head is accountable for the quality of the products manufactured at the site and ensures compliance with valid specifications and cGMP requirements.  The Quality Site Head is accountable for the quality of the clinical, commercial and launch products and ensures compliance with valid specifications and cGMP requirements. The Quality Site Head is taking the role and responsibilities as Responsible person (“Fachtechnisch verantwortliche Person”) according to Swissmedic regulations/ legislation. 

The focus of Basel Drug Substance is manufacturing of small molecule API, antibody drug conjugates, and biologics drug substance.  The Quality Site Head is a member of the Internal Quality Leadership Team, an extended PTQ LT member, a member of the Site Leadership Team and partner to the Site Head. 

Key Responsibilities:

Quality Management and oversight:

Ensure that manufactured products meet regulatory, analytical and QMS standards, along with evolving regulatory expectations (cGMP)

Develop and align strategic goals for quality monitoring, review, testing, and timely reporting - along the key Compliance pillars of `in place - in use - in control`

Provide leadership for Quality functions, manage staff performance and development, and drive accountability for Quality performance and efficiency across site operations

Manage Health Authority inspections by maintaining a consistently “inspection ready” state and responding appropriately to any findings

Supervise Quality Control (QC) matters and collaborate with BBK QC on testing methods and resolving potential non-conformities, all while maintaining effective Quality governance and compliance with regulatory requirements

Leadership:

Develop and communicate Site-wide organizational strategies that ensure GMP compliance, continuous improvements, and long-term goal achievement, while leading and managing the Quality Unit’s performance and development

Build a culture of continuous improvement, model lean leadership principles, and manage people processes including selection, hiring, promotion, compensation, and training

Partner with the Site Head on strategic business directions and the Site performance, and build strong partnerships with site and network leaders to ensure alignment on projects and daily activities

Develop annual budgets, revise forecasts, and monitor/control expenditures to ensure efficient use of company resources

Serve as the decision-maker for Quality matters, including managing product testing, assessments, product disposition, Health Authority inspections, third-party audits, and Quality and Compliance Risks

Sponsor and lead the site Quality Council, chair the Quality Review Board, ensure site operations stay in sync with company requirements, and cultivate a continuous improvement culture

Who you are:

You possess a Master’s degree in Life Science, Pharmacy, or related field (PhD preferred), approximately 15 years of industry experience with significant management experience, knowledge of cGMP regulations, and proficiency in German as required by Swissmedic for FvPs

If you are ready to join an exciting and ambitious environment where science and patient health is your purpose, please submit your application.

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.

Roche is an Equal Opportunity Employer.