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Cell and Gene Therapy (CGT) Quality Program Owner m/f/d 

YOUR TASKS AND RESPONSIBILITIES:

As the Cell and Gene Therapy (CGT) Quality Program Owner, you are fully accountable for the design, development, and implementation of core Quality programs, standards, and requirements for all CGT activities across the Bayer network. Your role is crucial in advancing Quality requirements for the CGT area, leveraging your knowledge of Cell and Gene Therapy, practical understanding of ATMPs, and commercial expertise. You will build solid relationships with cross-functional and cross-company stakeholders to ensure compliance with the Quality Management System standards. This role requires you to use your influencing, coaching, and visionary skills to guide the implementation of a roadmap in a dynamic, fast-paced environment.

KEY TASKS 

• Ensure quality of CGT products across all platforms and domains by building global processes that drive program standards;
• Establish a Quality Management System program and implementation roadmap covering regulatory requirements from development to commercial phases;
• Act as a quality advocate between development, manufacturing, supply chain, Product Teams, and regulatory affairs;
• Provide expertise in regulatory requirements and facilitate FDA inspection readiness activities for ATMP facilities;
• Foster open communication and collaboration among team members and stakeholders, encouraging discussion and input;
• Build and maintain strong relationships with internal and external stakeholders, including CGT affiliates and partners;
• Accountable for building Quality Assurance and Quality Control programs for CGT production from early phase to industrial scale-up;
• Provide expertise and guidance to CGT Affiliate sites to ensure compliance with CGT program expectations;
• Manage the contract testing laboratories network and participate in industry collaborations to stay on top of trends.

WHO YOU ARE:

• PhD/MD in Biotechnology, Virology, Cell-Engineering, Pharmaceutical-technology, or related field;
• Experience with both late-stage development and marketed CGT products;
• In-depth understanding of regulatory requirements related to CGT and ATMPs;
• Demonstrable grasp of a wide range of technologies as applied to gene therapy products;
• Experience in writing regulatory documents and working in a cGMP environment;
• Visionary leadership qualities to guide teams and align efforts towards common goals.
• Practical mindset in ATMP advancement with a focus on practical solutions;
• Deep understanding of CGT-specific regulatory requirements and experience with regulatory interactions;
• Collaborative leadership qualities that promote inclusivity and break down silos within teams;
• Strong interpersonal skills to advocate for quality across various departments;
• Excellent communication and negotiation skills, with a coaching mentality to enable team growth.

Location:

Switzerland : Basel-City : Basel  

Division:

Pharmaceuticals

Reference Code:

863389