Director, Director, Manufacturing Technical Services Quality Cell and Gene

Job Description

General/Position Summary

The Director, Manufacturing Technical Services, Quality Assurance is responsible for the quality oversight Quality services for operational activities covering the internal manufacturing sites, and test labs for Cell & Genetic Programs. This includes quality oversight of events and site quality management systems such as training, documentation and change control. The role will support external vendor quality activities as applicable.
The quality role will closely partner with internal site quality partners as well as operational stakeholders to execute associated governance for oversight. The successful candidate will be a key member of the Vertex Cell & Genetic Therapy Quality Team and operational teams.

Key Duties & Responsibilities

Lead quality team to manage technical services, quality assurance, for the Cell & Gene internal manufacturing sites.
Partner within the Quality organization and cross functional partners to prepare for quality management reviews.
Leads from a Quality perspective root cause analysis and product impact assessments for investigations resulting from deviations. Assure appropriate correction, interim controls and CAPAs are in place to mitigate risks.
Lead quality monitoring, assess for trends and gaps, lead risk mitigation and remediation activities.
Manage change management, including impact assessment and implementation of quality actions.
Support vendor notifications as part of product life cycle management that impact the sites CGT Programs.
Liaises with cross-functional teams and support quality partners to ensure GMP manufacturing and testing activities, including disposition timelines are met.
Leads/executes continuous improvement activities.
Work closely with the Audit and Inspection Quality Function to establish the audit strategy for Auditing and Performance oversight and support technical site audits including preparation for regulatory inspections.
Support vendor quality oversight processes including qualification, risk categorization and routine monitoring.
Participate in Cell & Genetic Program and Quality projects.

Required Education Level

Bachelor's degree in a biotech/Lifesciences field.
Master's degree or relevant comparable background.

Required Experience

Typically requires 10+ years of relevant industry experience such as manufacturing, quality assurance, and/or quality control in biotechnology/regulated pharmaceutical environment and 2+ years of supervisor/management experience or equivalent combination of education and experience.

Required Knowledge/Skills

In-depth global regulatory agency knowledge and experience across GXP life cycle in Cell & Gene therapy and/or Biologics.
Broad understanding of regulatory environment including quality systems, compliance and strategy.
Broad technical knowledge in Cell technology, aseptic manufacturing technology, analytical assays, cell & genetic therapies/Biologics processing, fill/finish and testing.
Ability to lead improvement projects - experience with Root Cause Analysis, data analytics, and other Operational Excellence experience, such as LEAN, DMAIC, Six Sigma.
Substantial experience with electronic document management systems (e.g., QDoccs, Trackwise, Veeva)
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.
Substantial background in managing complex projects/teams within stated objectives and timelines and with a strong understanding of the underlying business drivers;
Critical Thinking and Problem Solving skills
Strong leadership and an innate ability to collaborate and build relationship

Other Requirements

15% Travel required internationally.

On-Site Role

On-Site designated role, you will work five days per week on-site with ad hoc flexibility.

#LI-Onsite #ND-2

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, or contact Talent Acquisition at [email protected]