Director Of Quality Assurance

We are recruiting a talented and experienced Director/Senior Director Quality Assurance to help build our GMP manufacturing organization. S/he will work closely with Lyell manufacturing leadership to develop and grow the quality culture within the organization, including establishment of the infrastructure, hiring and training members of the team, assisting in the commissioning and readiness of a new GMP manufacturing facility, developing training and documentation systems, as well as other key elements of building the quality organization.

The successful candidate will have experience with GMP manufacturing and testing activities in the cell and gene therapy space, experience with CMC project timelines and a thorough understanding of the technological requirements to execute on the manufacturing needs of a cellular therapy company.

Responsibilities

• Provide leadership and oversight of the quality assurance function within Lyell.

• Responsible for building a high-performing quality team to ensure a robust quality culture, including building systems and teams to deliver:

• SOPs/Document Management:
Approval of all batch records, specifications, sampling instructions, test methods etc. and other cGMP procedures directly related to operations and other cGMP activities

• Develop and oversee Out-Of-Specification (OOS) and investigation procedures

• Deviation/CAPA Program:
Develop a system to capture deviations from established procedures and ensure appropriate documentation, investigation and determination of root cause

• Vendor Qualification/Raw Material Release:
Ensure phase-appropriate assessment and testing of starting materials, packaging materials, intermediates, bulk and finished product

• QC Testing/Batch Release:
Review and approve all batch release activities (manufacturing operation and release testing) to ensure compliant and timely product disposition

• Training:
Develop a training/documentation system to ensure all personnel, contractors, consultants and temporary employees have the proper qualifications, skill sets, education, and training to perform their job in accordance with applicable procedures and regulations

• Validation/Maintenance:
Ensure appropriate annual qualification status is maintained for necessary equipment and facilities in area of responsibility

• Establish an external vendor quality audit program

• Review manufacturing batch documentation and provide recommendations for lot disposition based on assessment of lot conformity to established quality specifications and regulatory requirements

• Lead/participate in the selection of contract manufacturing, testing, and distribution suppliers (conduct audits as needed)

• Provide quality input during manufacturing runs at CMOs

• Perform risk assessment(s) and implement appropriate quality and process controls to ensure proper oversight of all GMP activities

• Establish key quality metrics for management review (e.g., plant metrics, quality and compliance metrics)

• Serve as a key member of the manufacturing leadership team to establish strategy, budget, and operation workplans

Qualifications and Experience

• A minimum of 7 years of experience in biotechnology quality assurance/control spaces, GMP manufacturing, and/or CMC development.

• Experience managing individuals and teams in a regulated GxP setting (e.g., manufacturing or analytical testing of products).

• Demonstrated track record in effectively managing partners/contractors/vendors and implementing cGMP compliant quality systems.

• Extensive working knowledge of GMP regulations and experience interacting with regulatory agencies.

• Excellent interpersonal skills; builds effective interactions with a broad range of internal and external organizations, teams, and individuals.

• Ability to think critically, solve complex problems in real time and work collaboratively across disciplines.

• Strong integrity profile, demonstrated ability to lead in a complex, regulated and fast paced work environment.

Preferred Education

• BS/MS in a scientific discipline (e.g., Immunology, Molecular/Cellular Biology, etc) or related area and at least seven years of progressively responsible experience in Quality Assurance within the life sciences industry or equivalent; 3 years must be in management or leadership role.

Preferred Additional Skills

• Must have excellent 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.

• Excellent analytical skills and scientific/technical expertise.

• Ability to travel 20%.

• Cell therapy experience is a plus.

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