Manager, Quality Systems Cell And Gene

Job Description

General Summary:

The Quality Systems Manager provides technical and strategic leadership for quality systems, quality processes, and associated governance for the cell and gene therapy business unit. This position focuses not just on the "what" but the "how", ensuring phase appropriate and risk-based compliance.

Key Duties and Responsibilities:

• Supports local Quality system oversight, metrics, and improvement including change control, events, CAPA, escalation, and risk management.

• Collaborate with internally and external business partners to resolve quality issues to ensure compliant solutions

• Work with global quality and functional areas to ensure quality systems processes are scalable and flexible including integration of new modalities into the quality systems as Vertex expands its scope of operations

• Responsible for coordinating, facilitating and follow up on any QLT action items assigned.

• Lead or support process/product improvement projects

• Provide technical and strategic support to functional areas including other quality groups for quality system related issues

Knowledge and Skills:

• Good understanding of both the conceptual and practical application of cGMPs in a pharmaceutical setting

• Ability to evaluate quality matters and make decisions utilizing risk-based approach

• Technical knowledge including but not limited to: risk management, quality systems, and quality governance

• Proven experience leading a variety of straightforward projects/teams within stated objectives and timelines.

• Solid quality culture knowledge and understanding of how to influence and improve overall compliance

• Strong communication skills (written and verbal) with the ability to communicate to a variety of audiences.

• Experience with electronic document management systems (e.g., Trackwise, Veeva)

Education and Experience:

• Bachelor's degree in scientific or related field.

• Typically requires 4 years of experience, or the equivalent combination of education and experience

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 ApplicationAssistance@vrtx.com