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

Bayer•Berkeley, CA

16h•Onsite

About The Position

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.

Requirements

Experience with CGT Products: Trackable experience in CGT Quality Assurance and familiarity with manufacturing processes and release criteria for CGT products
Practical Mindset in ATMP Advancement: The candidate should have a hands-on approach to advancing Advanced Therapy Medicinal Products (ATMPs) with a focus on practical solutions
Project Management Skills: Strong project management capabilities to handle both tactical and strategic elements of the role
Flexibility and Agility: The ability to adapt to changing environments and pivot strategies as necessary.

Nice To Haves

Degree in Life Sciences, Engineering, or a related field is preferred. Advanced degrees (Master's or PhD);
Proven track record in Quality Assurance specifically within Cell and Gene Therapy (CGT) or Advanced Therapy Medicinal Products (ATMP);
Experience with both late-stage development and marketed CGT products;
Strong background in Quality Management Systems (QMS) and experience with quality audits;
Knowledge of critical quality attributes and process parameters relevant to CGT products;
Experience with advanced risk management techniques, including FMEA (Failure Mode and Effects Analysis);
Ability to manage risk effectively throughout the product lifecycle;
Experience in managing timelines and deliverables related to quality assurance;
Excellent verbal and written communication skills to interact with various stakeholders, including regulatory agencies;
Ability to communicate complex information clearly and effectively across different teams and cultures;
Strong interpersonal skills to foster collaboration and act as a quality advocate among development, manufacturing, and regulatory teams;
Ability to build relationships and work cross-functionally within an organization;
Ability to adapt to changing regulatory and operational environments;
Flexibility in adjusting strategies and approaches based on evolving needs and priorities;

Responsibilities

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.
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.
Ensure all documentation and processes are aligned with regulatory standards and best practices.
Collaborate with Regulatory stakeholders to support the Regulatory filing and documentation needs
Actively participate as the Quality point of contact for projects by ensuring timely completion of tasks and deliverables.
Coordinate cross-functional teams to address quality-related challenges and ensure alignment with project goals.
Ensure timely communication of project milestone deliverables when at risk
Foster open communication and collaboration among team members and stakeholders, encouraging discussion and input during meetings.
Communicate effectively with regulatory agencies and internal teams to ensure clarity on quality expectations.