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:
Flex Designation:
Hybrid-Eligible Or On-Site EligibleFlex 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.
Manager, Quality Systems Cell and Gene • Boston, MA
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