Senior Director, Regulatory and Quality
At Lyell, our vision is to develop curative cell-based immunotherapies for solid tumor cancers. We have innovative science originating from our founder’s world class labs and a unique and disruptive approach to research and development. Our company is first and foremost focused on understanding the science. We are a learning organization, dependent on deep collaborative relationships between all of our colleagues, partners and founders. Our culture is based on Respect, Science, Courage and Collaboration and it reflects who we are and the environment we are creating.
The Senior Director of Regulatory and Quality is responsible to build and lead the Regulatory, Quality Assurance (QA) and Quality Control (QC) functions across all regulated programs and processes. The Senior Director and their team will work alongside our Product Development and Operations teams, providing regulatory and compliance guidance in support of all Lyell GXP functions, including but not limited to, internal and external manufacturing and testing, non-clinical studies and clinical trials.
You will be accountable for ensuring that all products in the Lyell portfolio have a successful non-clinical, clinical and CMC regulatory strategies and submission execution plans. This individual should bring both a track record of successful regulatory approvals that demonstrate core capability in product development and commercialization, as well as a passion to challenge conventional paradigms and influence global Health Authorities.
You will serve as a key leader of the Technical Operations and Clinical Development teams and will be responsible for overseeing the development and implementation of Lyell quality management systems and will establish Strategic Regulatory and Quality Objectives in support of development programs and corporate goals. This position will drive and cultivate a culture of quality throughout Lyell to support compliance with all applicable regulatory requirements, guidelines, and corporate standards, policies, and procedures.
- Regulatory Affairs
- Manage proper filing of all required compliance documents, submissions, registrations in accordance with company business objectives.
- Ensure overall compliance with regulatory requirements (safety reporting, annual reports, investigator updates).
- Maintain current working knowledge of FDA and global regulatory requirements.
- Interact with Health Authorities to define regulatory strategies and secure approvals.
- Provide regulatory leadership and oversight for Lyell’s overall product development portfolio.
- Ensure departmental and program regulatory objectives are aligned with overarching goals of Lyell and product development.
- Provide regular communications and updates to management as well as liase with external partners and collaborators.
- Ensure Lyell has a process for development of regulatory intelligence in areas of key importance and influence regulatory policies and guidance through active participation in commenting processes, conferences, etc.
- Ensure development of and compliance with internal SOPs and policies regarding regulatory operations, document management and communication.
- Quality Assurance
- Establish and optimize Lyell Quality Management System (QMS) processes including Change Control, Document Control, Risk Management, Deviations, CAPA, Training, Product Complaints, Audits, and Vendor Qualification.
- Ensure alignment of QMS across Lyell sites.
- Lead the development and reporting of Quality metrics and periodic reporting depicting GXP compliance trends and any areas of risk with associated mitigation plans.
- Develop and create Lyell Quality infrastructure and strategic direction in conjunction with Clinical Operations and Manufacturing.
- Provide guidance on GCP compliance matters within clinical study teams.
- Establish and maintain adequate GXP training programs to support aggressive corporate growth plan.
- Serve as an escalation point for corporate quality issues including investigation, recalls, deviations, CAPA, change controls, audits, validation and training.
- Ensure that the company, its contractors and vendors are prepared for FDA and other Health Authority audits. Coordinate and host all GXP inspections.
- Develop plans and programs to support continuous quality improvement.
- Develop and effectively manage department annual operating budgets for QA.
- Oversee the development and implementation of QC procedures and policies related to Lyell and vendor cGMP operations.
- Ensure that Lyell QC laboratories are maintained at a high standard of cleanliness and organization, equipment maintenance and calibrations are performed, and cGMP documentation is completed, reviewed, and archived in a timely manner.
- Work with key stakeholders including QC lead to develop execution plans for increasing capacity and throughput of QC operations.
- Collaborate to identify and mitigate risks in QC operations that could negatively impact the quality of patient therapies.
- Support corporate drive to implement Lean principles to increase quality and productivity.
- Provide Leadership
- Provide exceptional leadership skills to the organization including hiring, mentoring and developing Regulatory and Quality staff.
- Develop a vision, strategy, and plans that are innovative, forward-thinking and based on sound business judgement, considering scalability and sustainability.
- Use strong communication and teamwork skills to build strong relationships with stakeholders.
- Champion implementation of new technologies and systems.
- Ensure a culture of strong GXP compliance and risk management across Lyell.
- Role model Lyell Values and Lean Leader principles to establish a continuous improvement culture.
- A minimum of 15 years of work experience in the biotechnology industry with at least 10 years of progressive responsibility in Regulatory and Quality. 5 years must be in management or leadership role.
- Expert knowledge of FDA, EMA, MHRA and ICH regulations and guidelines.
- Experience in hosting domestic and global Health Authority inspections.
- Experience preparing, reviewing and executing regulatory documents to support clinical studies.
- Experience working with US and EU CMOs, suppliers, CROs and clinical sites.
- Experience with assessing new technologies in fast-paced, learning organization; preferably in a cross-functional setting where impact of new technologies is evaluated across research, development and commercial organizations.
- Experience is all phases of drug development; experience with cell therapy desirable.
- Extensive working knowledge of GXP regulations and experience interacting with regulatory agencies.
- Demonstrated ability to build effective, efficient teams, and drive change within organizations.
- Fast learner, adaptable, with enterprise viewpoint and excellent cross-collaboration and inter-personal skills.
- Motivated to work independently as well as in teams.
- BS/MS in a scientific discipline or related discipline.
- Must have excellent change management, oral and written communication skills.
- Ability to work independently and collaboratively among cross-functional teams.
- Ability to work efficiently, prioritize workflow, meet deadlines and balance competing priorities.
At Lyell, we believe that highest performing teams include people from a wide variety of backgrounds and experiences who respectfully challenge each other. We are committed to building an open, diverse and inclusive culture for all employees.
Lyell is proud to be an equal opportunity employer and does not discriminate on the basis of race, color, citizenship status, national origin, ancestry, sex, sexual orientation, age, religion, creed, physical or mental disability, medical condition, marital status, veteran status or any other characteristics protected under applicable federal, state and local laws.
We’ve learned from experience that some of the best people don’t always match our requirements perfectly - if you’re interested and think you could fit, please don’t hesitate to apply.