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

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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 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 Help Us Achieve Our Mission Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has approved medicines that treat the underlying causes of multiple chronic, life-shortening genetic diseases — cystic fibrosis, sickle cell disease and transfusion-dependent beta thalassemia — and continues to advance clinical and research programs in these diseases. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including APOL1-mediated kidney disease, acute and neuropathic pain, type 1 diabetes, myotonic dystrophy type 1 and alpha-1 antitrypsin deficiency . Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 14 consecutive years on Science magazine's Top Employers list and one of Fortune’s 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit www.vrtx.com or follow us on Facebook, Twitter/X , LinkedIn, YouTube and Instagram. The diversity and authenticity of our people is part of what makes Vertex unique, and we recognize that each employee brings diverse perspectives and strengths. By embracing those strengths and celebrating differences, we are fostering an inclusive culture where each of us can bring our authentic selves to work, inspire innovation together, and change people’s lives. Our vision is clear: to be the place where an authentic, diverse mix of talent want to come, to stay, and do their best work.