Head of Lab Support & Compliance

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 As part of our Pharma Technical Development (PTD) organization, we are committed to delivering the Pharma ambitions by bringing game-changing therapies from clinical phase I into the market to serve every patient, every day. Our core business is to develop safe, innovative, and effective drugs using cutting-edge technologies for manufacturing processes (Drug Substance and Drug Product), clinical supply, formulation, device, packaging, and analytical development. The Opportunity As the Head of Lab Support & Compliance, you will lead a section within the department Operations Support & Compliance (PTDC-T) to provide specific services and support in the area of analytical equipment qualification, calibration and lifecycle, stability/reference sample management, GMP compliance in these areas, and preparation of respective SOPs. This role is key to enabling smooth operations for colleagues in Technical Development and aligns with business requirements with several partners and stakeholders. The role covers and serves regional needs for PTD Basel, for Drug Substance/Drug Product manufacturing as well as Analytics & QC for Synthetic Molecules and Biologics and Devices. The role is anchored in PTDC ‚Synthetic Molecules Technical Development‘. Leading the Lab Support & Compliance section, your key contributions include: Engaging employees in the department, enabling their performance, and providing opportunities for personal and professional growth. Managing a portfolio of activities in lab support and compliance, including resource allocation, priority setting, decision-making, and ensuring a GMP-compliant testing environment for Drug Substance, Drug Product, and Device testing in PTD Basel. Maintaining analytical equipment and infrastructure at state-of-the-art standards, overseeing qualification, calibration, change control, and maintenance. Overseeing sample and stability management for synthetic and large molecules, as well as devices. Providing leadership within the organization, participating in extended and functional leadership teams, contributing to long-term strategy, fostering a culture of continuous improvement, and collaborating with leaders and employees to build strong relationships across functional boundaries. Who You Are You have a PhD, an engineering degree, or a Master’s degree in a technical or scientific discipline and at least 10 years of industry experience in the pharma/biopharma business, with a minimum of 5 years of experience in technical and/or GMP-related disciplines. Experience within Small or Large Molecules GMP analytics or analytical development in Pharma is a plus. For this position, you bring the following qualifications: Excellent leadership and coaching skills with experience. Sound knowledge of GMP regulations and a deep understanding of health authority expectations. Strong ability to make decisions, inspire and lead changes, and assess risks. Excellent collaboration, interpersonal, influencing, and negotiation skills. Proven ability to build and maintain effective relationships with team members, internal and external partners, and stakeholders. Excellent verbal and written communication skills in English and German. Application deadline: 5 January 2025 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 childcare 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. #J-18808-Ljbffr