Cell and Gene Therapy (CGT) Quality Operations Subject Matter Expert

 

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 Operations Subject Matter Expert 

 

The Cell and Gene Therapy (CGT) Quality Operations Subject Matter Expert (SME) plays a pivotal role in advancing the CGT Quality Assurance (QA) program at the Berkeley site. This position involves active participation in the daily project and operational tasks within the CGT manufacturing facilities. Primarily focused on on-the-floor Quality Operations, the SME is responsible for enhancing the team’s understanding of Cell and Gene Therapy quality requirements. This includes coordinating the necessary tasks to successfully achieve aggressive and dynamic project milestones, as well as proactively resolving issues in a risk-based and phase-appropriate compliant manner.

 

The individual in this role must possess the ability to work independently, demonstrating excellent judgment and the capability to effectively engage with a diverse range of key stakeholders.

 

Additionally, the SME provides specialized knowledge and technical support in quality assurance and control processes within the organization. This position entails analyzing quality data, developing best practices, and advising teams on compliance with industry standards and regulations. The Quality Expertise team collaborates with various departments to implement quality improvement initiatives, conduct training sessions, and ensure that all products and processes align with established quality benchmarks.

 

YOUR TASKS AND RESPONSIBILITIES

 

The primary responsibilities of the Cell and Gene Therapy (CGT) Quality Operations Subject Matter Expert are to:

 

• Fully own the Quality Operational tasks required to ensure compliant and safe execution of CGT operational activities in the CGT MOD facility.
• Oversee quality assurance processes for CGT products from development to commercial launch.
• Engage with cross-functional teams to ensure compliance with Global Processes and Regulatory standards.
• Manage risks associated with CGT product development and manufacturing, including finding risk-based and phase appropriate solutions when issues arise.
• Foster a culture of open communication and collaboration among team members and stakeholders, with an aptitude to being able to have tough conversations when Quality decisions may not be favored across stakeholder groups.
• Provide coaching and mentorship to team members, promoting their professional growth and ensuring alignment to the Quality decisions made.
• Develop and implement strategies to improve quality assurance practices.

 

Quality Assurance Oversight:

• 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, and regulatory affairs.
• Provide risk-based solutions to issues that arise the ensure compliance to phase-appropriate Quality requirements, while also ensuring the flexibility to continue with process knowledge and development
• Implement advanced risk management strategies, including conducting investigations (e.g., FMEA) and managing risk profiles associated with CGT products.
• Identify and mitigate potential risks related to quality assurance processes.
• Implement global CGT program elements into local procedures to ensure compliance to CGT program expectations.
• Analyze past performance to prevent recurrence of issues and improve future outcomes.
• Promote a culture of continuous learning and improvement within the quality assurance team.
• Engage directly in daily quality assurance activities and provide hands-on support to team members as needed.
• Maintain a practical mindset when addressing unforeseen problems and developing solutions.