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Director, GMP Operational Quality Cell and Gene
2 months ago
Job Description
General Summary:
The Director GMP Quality Operations is responsible for the quality oversight of operations of the manufacturing site for the manufacture of Cell Product, including management of direct reports and defining daily priorities to execute the team's responsibilities. The role is responsible for Quality oversight on the manufacturing floor and product disposition of clinical and commercial drug product.
The role will lead initiatives and participate in cross-functional project teams for the development of Cell & Genetic Therapeutic Programs as well with the roadmap to transforming to a commercial level operation.
Key Duties and Responsibilities:
- Responsible for Quality oversight of Vertex Cell and Gene Therapy manufacturing internal operations across all phases of development and commercial, support of analytical laboratory, materials management, and facility/engineering groups.
- Collaborate with internal business partners to prioritize and resolve complex quality issues, product quality impact assessments and identify compliant solutions.
- Responsible for GMP batch disposition activities including review and approval of batch records, deviations, in-process data, EM data, QC release testing, materials review board and other quality activities as applicable to determine acceptability of product disposition.
- Provide QA oversight of change controls, process and OOS investigations, and associated CAPAs.
- Review and approval of manufacturing documents such as technical and analytical protocols/reports.
- Support GMP release of incoming raw material and components.
- Responsible for timely identification of compliance risks and gaps for GMP processes, and implementing mitigating controls.
- Lead audit and inspection readiness activities.
- Lead timely and thorough audit response activities.
- Assist with addressing product complaints.
- Maintain monthly metrics to determine and share the health of the business.
- Assist department with routine/quarterly Quality System data review metrics and reporting.
- Lead and participate in Cell & Genetic Program and Quality projects and drive continuous improvement activities.
- Provide information to assist in budgeting, scheduling, project planning within GMP Operational Quality.
- Provide routine and/or requested business and culture updates to leadership.
- Responsible for the culture of the Quality team; facilitates team meetings, 1:1 meetings, skip level meetings, and takes appropriate action as applicable.
- Work effectively and efficiently in a fast-paced environment.
- Manage team workload and priorities to ensure tasks are completed.
- Develop and maintain an organization business continuity plan.
Knowledge and Skills:
- In-depth knowledge of both the conceptual and practical application of cGMPs in a pharmaceutical setting; Biotec/Cell & Gene GMP regulations and applicability.
- Demonstrated experience working in a manufacturing site, managing operations/ QA Operations and oversight of GMP manufacturing operations.
- Change agent, influencing skills and ability to work in a fast-paced dynamic environment.
- Experience with network-based applications such as Oracle, TrackWise, Veeva.
- Understanding of regulatory environment including quality systems and compliance.
- Knowledge of aseptic manufacturing technology, analytical assays, cell & genetic therapies/Biologics processing, fill/finish and testing.
- Ability to evaluate quality matters and make decisions utilizing a risk-based approach.
- Critical Thinking and Problem Solving skills.
- Ability to independently lead cross-functional teams, and effectively communicate with business stakeholders.
- In-depth knowledge of gowning and clean room behaviors.
- Excellent communication skills.
- Ability to effectively communicate up and down the organization.
- Ability to utilize team's strengths to efficiently achieve goals.
- Lean Transformation and/or Continuous Improvement experience.
Education and Experience:
- Bachelor's degree in a scientific or allied health field (or equivalent degree) or
- Master's degree or relevant experience background.
- 8+ years of commercial GMP industry Manufacturing and Quality Assurance experience in a regulated biotechnology/regulated pharmaceutical environment.
Hybrid-Eligible Roles
In this Hybrid-Eligible role, you can choose to be designated as:
On-Site: work five days per week on-site with ad hoc flexibility.
Flex Designation:
Hybrid-Eligible or On-Site Eligible.
Flex Eligibility Status:
In this Hybrid-Eligible role, you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On-Site: work five days per week on-site with ad hoc flexibility.
Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.
Company Information
Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager.
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