Director QA, GMP External Operations Cell and Genetic Therapies - VCGT

Job Description

General/Position Summary

The   Director ,   Quality   Assurance GMP Operations   is responsible for the   applicable   Cell & Gene   CDMO   and is responsible for the   end to end   quality oversight of all   product   and activities   at the CDMO.      Responsibilities include   day-to day operational   quality oversight   including assuring progression   of   batch record   operations ,   resolution and   on time disposition   of product,   quality continuous improvements,   changes associated with the process and associated implementation, trends, and overall quality performance of the CDMOs .

The role will closely partner with operational stakeholders to lead/support the development and execution of quality & technical risk   mitigation, execution of operational activities   and   participat ion   in   governance committees .     A key expectation is the ability to closely collaborate and build relationships with   internal   and external   stakeholders   to   drive compliance and continuous improvement activities .    The role may also be required to support on site manufacturing activities   at the CDMO .

Key Duties & Responsibilities

Establishment of quality oversight for external C T O/C D MO operations   including assurance of on time of   batch disposition process ,   across development, launch and commercial   manufacturing globally.

Lead, Develop, and implement   continuous   quality   improvements   to a dvanc e   quality outcomes and operational excellence   in processes.

Proactively   develop   Compliance metrics as key indicators   and takes action to mitigate .

Maintain full oversight of   CDMO QMS   including driving deviation   reduction   a nd assuring timely resolution of CAPAs.

Act as the SME for the CDMO ,   understanding   scope of all changes, driving applicable global change control implementation with the external manufacturing partner to meet global product goals.

Represent Quality and serve as a trusted   partner for the disposition   activities of drug product.

Build strategic relationships   and foster a culture of collaboration   with internal and external partners – CDMOs and CTOs within the Quality organization   to ensure Quality issues are raised and addressed, as necessary.

L ead/support the development of quality & technical risk   mitigation   through identification and mitigation compliance gaps .

Lead and mentor other team members, support development of organizational capabilities and talent building.

Act as   the batch disposition   subject matter expert (SME) in support of regulatory inspections and audits.

Establish /parti ci pate   and lead GxP Cell & Gene Therapy Management Reviews to gain insights regarding efficiency and operational performance across the GXP operations, including identification of opportunities for improvement and associated actions.

Work closely with the cross- functional partners to prepare for and support Health Authority inspections, respond to information requests, adjudicate compliance discussions, and negotiate any required corrective actions.

Represent C&G Quality to lead/participate in complex projects and partner with key stakeholders for alignment in strategic and operational planning and delivery of business & financial priorities and goals.

May be required to support manufacturing on site activities.

Required Education Level

Batchelor 's degree or relevant comparable background.

Masters preferred.

Required Experience

10 + years of experience and   5 + years in a management/supervisory role, or the equivalent combination of education and experience in a regulated pharmaceutical environment

Required Knowledge/Skills

In-depth global health regulatory agency knowledge and experience across GXP life cycle in Cell & Gene therapy and/or Biologics   (EU GMPs, FDA 21CFR Part 1271,   GxPs ).

Broad and c urrent knowledge of   batch disposition   industry trends and best practices in Cell/Gene therapies.

Preferred QA Operational experience for Autologous Cell Therapy Operations.

Broad technical knowledge in Cell technology, aseptic manufacturing technology, analytical assays, cell & genetic therapies/Biologics processing, fill/finish and testing.

Demonstrated strategic planning and execution skills required for operational effectiveness and compliance.   P roven   ability   with Root Cause Analysis, data analytics, and other Operational Excellence experience, such as LEAN, DMAIC, Six Sigma.

Excellent communication skills and a proven track record Influencing/building/promoting a culture of Quality and Excellence.

Ability to apply risk management principles to decision making and operational priorities.

Critical Thinking   and   Problem Solving   skills

Ability to closely collaborate and build relationships with   internal   and external   stakeholders .

Other Requirements

Indicate required certifications, licenses or specialized trainings.

Up to   25 % Travel   may be   required

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.

#LI-Hybrid

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, or contact Talent Acquisition at ApplicationAssistance@vrtx.com