Job Description

At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.

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

The Cell and Gene Therapy (CGT) Quality Program Owner is fully accountable for the design, development, and implementation of the core Quality programs, standards, and requirements for all CGT activities across the Bayer network. You will leverage your Cell and Gene Therapy knowledge, practical understanding of ATMPs, commercial expertise, and interpersonal and communication skills to advance Quality requirements in the CGT area of Bayer Business. This role involves building solid relationships and partnerships with cross-functional and cross-company stakeholders to ensure compliance with the Quality Management System standards you architect within your matrixed organization of local and global subject matter experts (SME). You will use your influencing, coaching, and visionary skills to build a roadmap and guide its implementation in a dynamic, fast-paced environment.

YOUR TASKS AND RESPONSIBILITIES

• Ensure quality of CGT products across all platforms and domains by building global processes that drive program standards across Bayer sites with CGT activitie
• Establish a Quality Management System program and implementation roadmap covering Quality regulatory requirements from development to commercial phases
• Ensure compliance with regulatory requirements (GxP, ATMP) and internal quality standards throughout the product lifecycle
• Act as a quality advocate between development, manufacturing, supply chain, Product Teams, and regulatory affairs
• Develop and implement strategic plans for the CGT Quality Oversight program and collaborate with the QMS Global team
• 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 during meetings
• Ensure that all standard operating procedures (SOPs) and quality documents are properly structured, updated, and compliant with current regulations

WHO YOU ARE

• PhD/MD in Biotechnology, Virology, Cell-Engineering, Pharmaceutical-technology, or related field
• Several years of professional experience in industry in Cell or Gene Therapy Quality Assurance, with familiarity in manufacturing processes and release criteria for CGT products
• Hands-on approach to advancing Advanced Therapy Medicinal Products (ATMPs) with a focus on practical solutions
• Deep understanding of CGT-specific regulatory requirements (GxP, ATMP regulations) and experience with regulatory interactions
• Leadership capabilities that promote collaboration and inclusivity, breaking down silos within teams
• Coaching mentality to enable team members to grow and learn
• Strong interpersonal skills to advocate for quality across various departments (Development, Manufacturing, Supply Chain, and Regulatory Affairs)
• Ideally you have a demonstrable grasp of a wide range of technologies (qPCR, ddPCR, ELISA, SDS-PAGE, in-vivo potency) as applied to gene therapy products is required as well as an understanding of commercial readiness activities
• A background in Quality Management Systems (QMS) and experience with quality audits would be a plus
• Excellent English communication and negotiation skills to foster discussions and align team efforts effectively

WHAT WE OFFER

Our benefits package is flexible, appreciative, and tailored to your lifestyle, because: What matters to you, matters to us!

• We ensure your financial stability with a competitive salary between 129.700 EUR and 163.800 EUR per year (full-time) plus a variable component and a global equity-based cash plan. Your compensation is based on your qualifications, skills, and professional experience
• Whether it’s hybrid work models or part-time arrangements: Whenever it is possible, you will have the flexibility to work how, when and where it is best for you
• Your family is a top priority. We offer loving company daycare centers at multiple locations, support in finding childcare, time off for the care of elderly or dependent family members, summer camps for children, and much more
• We support your professional growth by providing access to learning and development opportunities, training programs through the Bayer Learning Academy, development dialogues, as well as coaching and mentoring programs
• We promote health awareness and opportunities for selfcare through various measures, such as free health checks with the company doctor
• We embrace diversity by providing an inclusive work environment in which you are welcomed, supported, and encouraged to bring your whole self to work.

YOUR APPLICATION

This is your opportunity to tackle the world’s biggest challenges with us: Maintaining our health, feeding growing populations and slowing the rate of climate change. You have a voice, ideas and perspectives and we want to hear them. Because our success begins with you. Be part of something big. Be Bayer.

Bayer welcomes applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.

Location: ​ ​ ​ Germany : Berlin : Berlin || Germany : North Rhine Westfalia : Leverkusen || Germany : North Rhine Westfalia : Wuppertal-Elberfeld​

​ ​Division: ​ Pharmaceuticals​

Reference Code: 863954​