Director of GMP Operational Quality Cell and Gene
4 weeks ago
The Director of GMP Operational Quality Cell and Gene 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.
Key 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.
Assists 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.
Provides information to assist in budgeting, scheduling, project planning within GMP Operational Quality.
Provides 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.
Manages team workload and priorities to ensure tasks are completed.
Develops and maintains an organization business continuity plan.
Requirements:
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 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, 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.
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