Job Description General Summary: The Associate Director (AD) Quality Assurance (QA for QC) is an advanced technical resource in the principles and application of quality assurance and compliance. This role is responsible for the quality oversight of Quality Control and analytical development activities of Cell & Gene programs. Activities in scope of this role include release analytical testing, stability testing, and QA support for deviations and out of specification investigations. The role will have QA oversight of technical analytical method validations and analytical transfer activities internally /CDMOs through the program life cycle management. Key
Duties
and
Responsibilities
Analytical Lifecycle Management: Serve as a Quality Assurance Subject Matter Expert for in QC domain and drive culture of quality to assure compliance with FDA, EMA, and internal SOPs. Lead QA review and approval of analytical development, qualification and validation as well as analytical technical transfer activities Ensure stability program is conducted in compliance with established protocols and applicable regulations. Review relevant sections of regulatory submissions; Assist in responses to regulatory questions. Compliance & Investigations Ensuring proper root cause analysis (RCA) and Corrective and Preventive Actions (CAPA) for Out of Specification (OOS) and Out of Trend (OOT) results Perform/lead QA review and approval of QC associated documentation including deviation investigations, OOS, OOT and change control. CTO & CMO Management: Execute QA operational oversight for internal QC laboratories and external contract testing laboratories. Drafts and enforces Quality Agreements between Contract Test Labs and Vertex. Digital & Artificial Intelligence Demonstrated understanding of digital quality systems, data management, automation, and emerging AI technologies within regulated GxP environments.
Experience
leveraging data analytics, digital tools, and AI-enabled solutions to improve quality oversight, operational efficiency, and decision-making. Responsible for using platforms such as MES, LIMS, eQMS, data visualization tools, and advanced analytics to perform Quality oversight. Quality Management Systems (QMS): Utilizing eQMS platforms for change controls and deviation tracking Acting as the subject matter expert (SME) during audits and inspections regulatory agencies Support/lead QA risk management activities, including mitigation plans and associated execution. Support development of Vertex quality systems and processes, draft/revise SOPs, policies and work instructions. Identify, facilitate, and/or lead continuous improvement efforts Ensure development of quality metrics at the contract organizations that support excellence in quality systems Knowledge and Skills: In-depth global regulatory agency and technical knowledge and experience across GXP QA and QC activities in cell therapies Broad understanding of regulatory environment including quality systems, compliance and GMP regulations.
Experience
with platforms such as MES, LIMS, eQMS, data visualization tools, and advanced analytics is preferred. Prior experience working /running internal analytical lab and working with external Test labs.
Experience
in analytical method development Ability to lead improvement projects - experience with Root Cause Analysis, data analytics, and other Operational Excellence experience, such as LEAN, DMAIC, Six Sigma. Excellent communication skills and a proven track record Influencing/building/promoting a culture of Quality and Excellence. Critical Thinking and Problem Solving skills
Education
and
Experience
Master's degree in a scientific or allied health field (or equivalent degree) Ph.D. preferred 8+ years of experience, or the equivalent combination of education and experience in a regulated pharmaceutical environment. Other
Requirements
Up to 15% travel
Pay Range
$156,600 - $234,800 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: On-Site Designated Flex Eligibility Status: In this On-Site designated role, you will 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-Onsite 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.