Vertex Pharmaceuticals

Director, GMP Operational Quality Cell and Gene (On-site)

Vertex Pharmaceuticals, Boston, MA, United States

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
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

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. (e.g. FDA, ICH, USP, etc. or other industry best practices ex. ISPE, WHO, etc.)
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.

#LI-On-site #LI-ND2

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.