Associate Director, Quality Systems - Cell and Gene Therapies (VCGT)

Vertex Pharmaceuticals; Boston (MA); On-site; USD 148,000 - 222,000; Full time

Job summary

Vertex Pharmaceuticals is seeking an Associate Director of Quality Systems for Cell & Gene Therapies (VCGT) in Boston. This role partners with cross-functional teams to harmonize QMS strategy, processes and procedures, driving quality improvements across CGT programs.

The position requires a strong background in GMP, risk management, and data integrity, with extensive leadership experience in a matrix environment. Travel up to 15% may be required; hybrid work options are available.

Qualifications

• Broad and deep expertise in global GMP regulations, guidances, and Quality Management Systems.
• Strong leadership skills with ability to collaborate in a dynamic cross-functional matrix.
• Ability to manage complex projects and teams within corporate objectives and timelines.
• Excellent technical writing, presentation and communication skills.
• Experience in investigations, root cause analysis and CAPA.

Responsibilities

• Lead for APQR and QPQA to ensure on-time execution per procedures and regulatory requirements.
• Lead VCGT Data Integrity program and define DI strategies at the site level.
• Provide local Quality system oversight including change control, events, CAPA, escalation, and risk management.
• Monitor and communicate QMS process metrics and remediation plans.
• Collaborate with internal and external partners to resolve quality issues and enable compliant solutions.
• Support audits and drive continuous improvement across VCGT QMS/Compliance.

Skills

GxP compliance

Quality Systems

Project management

Leadership

Regulatory knowledge

Data integrity

Root cause analysis

Education

Bachelor's degree in science

Tools

QMS software

CAPA system

Job description

## Associate Director, Quality Systems - Cell and Gene Therapies (VCGT)Applylocations: Boston, MAtime type: Full timeposted on: Posted Todayjob requisition id: REQ-29575**Job Description****Position Summary**The Quality Systems Associate Director supports strategic design of and ensures tactical execution of quality systems, risk management, and quality culture across the Vertex Cell and Gene Therapy (VCGT) organization. The role is responsible for partnering with cross-functional technical development and commercial teams to align and facilitate harmonization of strategy, procedures and processes related to the Quality Management System and to drive Quality improvements.This position reports directly to the Director of Quality.**Key Duties & Responsibilities****The responsibilities of this position may include, but are not limited to, the following:****-Process Lead for Annual Product Quality Review (APQR) and Quarterly Product Quality Assessment (QPQA) including:*** Responsible for leading and providing functional process oversight for APQR and QPQA* Ensure all APQR and QPQA are executed on time and in accordance with procedures and regulatory requirements* Monitor and support the quality risk management program items associated with CGT. Identify and implement continuous improvement projects to improve processes and make them efficient and scalable**-Process Lead for VCGT Data Integrity (DI) program*** Define DI compliance operational strategies to be deployed at the local site level and monitored for effectiveness, including governance* Collaborate with Global Process owner to identify and implement DI continuous improvement projects to mature processes and make them efficient and scalable* Responsible for local Quality system oversight, metrics, and improvement including change control, events, CAPA, escalation, and risk management* Leads the monitoring, interpretation, and communication of QMS processes and metrics requirements including remediation plans* Collaborates with internal and external business partners to resolve complex quality issues to ensure compliant solutions* Provide hands-on expertise in the day-to-day management of data collection systems and control within the GxP Quality Management System using digital solutions* Responsible for strategic, Risk Management monitoring support, and Data Integrity initiatives and activities to drive prioritization and in-support continuous improvement across VCGT QMS/Compliance processes* Supports internal audit or external audit programs* Works to enhance Quality Culture across VCGT organization* Provides Project Management leadership for department projects/initiatives.**Required Education Level*** Bachelor's degree in a scientific discipline, operations research, operations management, business administration or a related field**Required Experience*** Requires 10+ years of experience or the equivalent combination of education and experience* Experience in product life cycle from discovery to commercial product development**Required Knowledge/Skills*** Broad and deep expertise in global GMP regulations, guidances, and Quality Management Systems, as well as a strong understanding of industry standards and best practices across the GxP lifecycle* Strong leadership skills with ability to be agile and effectively collaborate in a dynamic, cross-functional matrix environment* Ability to assess impact across multiple procedures and systems* Ability to lead and manage complex projects/teams within corporate objectives and project timelines* Proficiency utilizing project management processes / tools to lead meetings, assist with project planning and facilitate completion of tasks* Excellent technical writing, presentation and communication skills* Ability to effectively influence others within technical area of expertise* Outstanding facilitation, communication, and coaching/influencing skills* Proven ability to lead improvement projects and project teams* Ability to navigate through ambiguity and rapid growth and adapt to change* Proven ability to identify and analyze performance indicators.* Extensive experience conducting investigations, performing root cause analysis and identifying CAPA**Other Requirements**Up to 15% travel**Pay Range:**$148,000 - $222,000**Disclosure Statement:**The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.**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