Manager, Risk Management and Business Continuity Programs
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 lead and manage multiple aspects of the Risk Management and Business Continuity Programs (BCP) within the Operations organization. This role will work closely with partner groups to expand and develop Risk Management and BCP processes, tools and methodologies within the function, and will support the continued development of a Risk- Intelligent culture across the company.
KEY ROLE AND RESPONSIBILITIES:
- Partners in the development and implementation of risk management processes and standard practices for the organization
- Leads the development and execution of risk management plans
- Provides risk management expertise and support to the function by way of advising on regulations, and operationalizing processes, principles, methods, tools, and standard methodologies
- Work closely with key collaborators to establish risk appetite and tolerance thresholds to be applied to risk-based decision-making
- Partner with operations teams to build upon an end-to-end process for coordinated risk management (including review and reporting approach) with associated governance
- Lead a cross-functional Operations Risk Network to facilitate and lead the risk process and serve as a risk administrator of the Operations Risk Register.
- Facilitate and supervise risk process adherence and enable transparency to risk mitigation field through operations-level governance
- Provide risk management and assessment support where needed across the organization
- Establish effective communication mechanisms demonstrating new and existing meeting and management system pathways
- Develop and deploy training programs to build risk management capability and process adherence across the organization
- Define and enable relevant process performance measures for concrete risk reporting
Business Continuity Planning
- Partner closely with internal collaborators to define and implement the Lyell Business Continuity Management (BCM) process for the operations function.
- Work closely with the operations sites and functions to facilitate the development and management of robust Business Continuity Plans (BCP) and mitigation strategies.
- Handle site BCP’s for sites including documentation, scenario modeling, testing, and continuous improvement
- Own the planning for the execution of testing exercises involving all levels of the organization for critical business functions/processes
- Develop policies and procedures to support the operations BCM process (including Business Impact Analysis, Crisis Response and Recovery Playbooks)
- Partner with internal functional leaders and key collaborators to develop and deliver training programs and materials to support the operations BCM process and program
- Stay current on understanding new applications, technologies, operational resilience approaches, and business continuity strategies
- Establish site and functional incident management teams to ensure coordinated response, recovery, and communications
- BA/BSc in Life Sciences or related field with a minimum of 10 years’ experience as a Risk Management practitioner
- MBA or MSc with a minimum of 8 years’ experience as a Risk Management practitioner
- Active LSS Green Belt or Black Belt certification preferred, and/or certification in Root Cause Analysis (RCA)
- Business Process Management training/certification.
- 5+ years of experience working in Cell Therapy, Biotech, Pharmaceutical or other GxP industries with demonstrated success defining and implementing Risk Management programs across multiple groups/functions
- Experience building risk capability and inspiring change within a diverse organization, including developing & delivering risk training programs, and demonstrating multiple communication strategies/platforms
- Knowledge and experience with Business Impact Assessments (BIA), Business Continuity Planning (BCP), and Crisis Management
- Experience building and leading cross-functional teams
KNOWLEDGE, SKILLS AND ABILITIES:
- Strong proven understanding of ICHQ9 and Quality Risk Management (QRM)
- Solid understanding of Operations functions and integrated approaches to Operational Risk Management
- Strong business and financial competence
- Familiarity with Risk Management data and information management approaches, including software and SaaS models
- Understanding of overall drug development process and early phase clinical studies
- Excellent interpersonal, communication and partner leadership skills
- Demonstrated ability to innovate, build, lead, and empower improvement teams across multiple functions
- Successful track record in implementing and driving programs, training and business processes that result in aligned objectives, right outcomes and timely stakeholder communications
- Experience defining and leading business processes with demonstrated understanding of BPM methodology and tools
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.