Quality Assurance Director, GMP

2 weeks ago

Berkeley, United States Caribou Biosciences Full time

Caribou Biosciences is a leading clinical-stage CRISPR genome-editing biopharmaceutical company dedicated to developing transformative therapies for patients with devastating diseases. Our next-generation genome-editing technology enables superior precision to develop cell therapies that are armored to potentially improve activity against diseases. We believe the future of cell therapy is off-the-shelf, and we are advancing our pipeline of off-the-shelf, or allogeneic, cell therapies from our CAR-T cell therapy platform as readily available treatments for patients with hematologic malignancies and autoimmune diseases.

Job Description: Sr. Mgr/Assoc Director Quality Technical Operations

Quality Technical Operations, Cell Therapy Manufacturing is responsible for leading the day-to-day quality review and approval of investigations, CAPA, Change Controls with associated documents and the oversight of the qualifications and validations of computerized systems, software, enterprise systems, equipment, methods, and manufacturing processes. The Director, Quality Technical Operations will serve as a primary delegate and proxy for the VP of Quality.

Responsibilities:

  • Responsible for QA oversight of cGMP operations deviations, CAPAs, Change Controls, and qualification/validation at the manufacturing facility. Drives for operational adherence to applicable cGMP regulations, Caribou policies and procedures.
  • Provides direction to CMC Operations, Facilities, IT, QC, and QA teams for planned and unplanned deviations to resolve compliance issues and procedural errors, ensuring immediate actions are taken, assisting investigators on deviation strategy and documentation, reviewing and approving deviations, supporting identification of appropriate CAPA, and supporting site awareness / retraining following any events.
  • Strategically identifies, implements, and (as assigned) leads site-wide QA transformational programs and strategies in close partnership with Quality Systems, CMC Operations, Supply Chain and Quality Control to reduce deviations, improve right first time, improve quality record timeliness, identify and remediate trends, improve turnaround time (TAT), and prevent issues before they occur.
  • Ensures timely Quality support and approval of GMP documentation, risk assessments and change control impact assessments.
  • Ensures the required processes, procedures, and systems are in place to enable a compliant manufacturing, storage, and supply of products.
  • Maintains a comprehensive understanding of process development, tech-transfer, manufacturing, analytical development, and QC testing processes and the associated risk management control strategy to identify process risks and associated critical controls around the associated processing steps.
  • Effectively partners with CMC leadership to enhance quality mind-set through timely, positive, constructive feedback and training.
  • May acts as subject matter expert for GMP operations during audits and regulatory inspections. Contributes to the development and execution of the inspection readiness plan. Supports Health Authority interactions, and ensures any regulatory observations are adequately addressed and completed on time.
  • Works together with the Quality Leadership Team to deploy a strategy for continuous improvement for quality oversite and QMS.
  • Provides situational leadership and collaborates with internal and external teams
  • Provides expertise and guidance in interpreting governmental regulations, agency guidelines and internal procedures to assure continued compliance.
  • Perform due diligence activities and audits (internal/external) on behalf of Caribou.
Knowledge & Skills:
  • Ability to build strong, trusting relationships, lead large/complex programs, and work across divisions, diverse business backgrounds and cultures.
  • Excellent communication and interpersonal skills, with the ability to interface with a broad range of internal and external stakeholders at all levels of the organization.
  • Strategic thinker who sees the bigger picture and possesses high business acumen; understands how the parts impact the whole (end-to-end enterprise mindset) and makes the best decisions for the whole.
  • Excellent influencing and negotiating experience and capabilities in a matrix environment. Must be able to interact with senior leaders as such is seen as a highly regarded and a credible leader with the ability to interface with stakeholders in a matrix environment.
  • Proven track record of delivering results and is action oriented.
  • Adapts to changing work environments, work priorities and organizational needs.
  • Leads within the broader internal and external network and seeks to have impact on organization-wide performance.
  • Embraces complexity but strives for simplicity.
  • Translates the case for change into actionable and strategic plans for the organization.
Basic Requirements:
  • Bachelor's degree in relevant Science or Engineering discipline.
  • 15+ years of experience in managing Quality Assurance functions.
  • At least 7 years of people management experience.
  • Expertise in Good Manufacturing Practices (GMP) as related to Pharmaceutical, Biotech and/or ATMP Manufacturing.
  • Experience with implementing and overseeing GMP operations plant manufacturing for clinical and commercial biological/ATMP products at CDMOs.
  • Knowledgeable of Digital Quality for IT systems and well-versed in FDA 21CFR Part 11 and EU Annex 11.
  • Demonstrated excellence in written and verbal communication.
  • Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships.
  • Proven leadership ability to carry out difficult decisions in a logical, rational manner, and demonstrated ability to work as a senior management team member and to engage and influence team members in a matrixed environment.
  • Strong presentation and visual management capability.
  • Knowledge of performance measurement tools and metrics.
  • Good facilitation, change management, interpersonal and problem-solving skills.
Preferred Requirements:
  • Background in Biologics or Cell Therapy Manufacturing is preferred.
  • Expert-level expertise in one or more of the following: Pharmaceutical Quality Management, Project Management and/or Lean Six Sigma strongly preferred.
  • Experience in management of large teams, including direct and indirect reports.
  • Preferred demonstrated experience building and leading exceptional teams.
  • Certified ASQ Auditor

This position is for a temporary or contract employee who Caribou Biosciences will not directly employ. Instead, the individual will be an employee of a third-party staffing firm and the Caribou team will manage their work activities. As a temporary/contract employee, you will collaborate closely with Caribou's internal teams and contribute to our mission while reporting and getting supported by the staffing firm. The compensation amount will be based on the budget and duration of the contract.

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