Manager, Supplier and Vendor Audit Program
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 Science, Respect, Collaboration and Courage and it reflects who we are and the environment we are creating.
You will be responsible for the design, implementation and execution of the supplier and vendor oversight program as well as the internal audit program. This role will be responsible for assessing GxP suppliers and executing questionnaires and audits as required. The incumbent will create and maintain the audit schedule and the approved supplier list. This is a cross-functional role that will ensure the organizations suppliers and vendors are acceptable to support GxP processes.
KEY ROLE AND RESPONSIBILITIES:
- Create the annual audit schedule, both internally and external to the function, and report on progress against activities and timelines.
- Lead cross-functional teams in the evaluation of suppliers and vendors to determine quality and criticality.
- Document, track, distribute and follow-up actions resulting from supplier questionnaires captured in the Quality Management System.
- Plan, execute and report on virtual and on-site audits of suppliers and vendors.
- Plan, execute and report on internal audits.
- Maintain the Approved Supplier List.
- Support third-party audits hosted onsite.
- Participate in cross-functional teams for bringing in new materials and vendors.
- BA/BSc with a minimum of 10 years’ experience; or
- MBA or MSc with a minimum of 7 years’ experience
- Professional Auditor Certification
- Minimum 12 years’ experience in GMP biopharmaceutical operations with a minimum of 8 years’ experience in GMP Quality and a minimum of 5 years’ experience as an auditor
- Demonstrated experience in Clinical and GMP manufacturing
- Proven experience with quality management systems (e.g. Deviations, CAPA, Risk, etc)
KNOWLEDGE, SKILLS AND ABILITIES:
- Deep knowledge and understanding of the regulations that govern GMP manufacturing and specifically cell therapy companies in the US, Europe and Japan
- Ability to work non-traditional work times to support remote audits in other time zones
- Ability to travel up to 10% of the time to perform on-site audits
- Proven strong leadership, collaboration and influencing skills, with demonstrated ability to problem solve and drive positive change.
- Motivated and organized critical thinker with solid interpersonal and business communication skills
- The desire and ability to work in a fast-paced, start-up environment
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.
The Company complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law. This position requires you to work onsite at the Company’s facilities and the Company requires that all employees working in its facilities be fully vaccinated (except as required by applicable law). Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for medical or religious reasons, and/or as otherwise required by applicable law. The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine. The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization.”
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.