QA Manager- Finished Goods Commercial

Job Description General Summary: The Quality Manager provides oversight of department activities, ensuring alignment with corporate goals and regulatory requirements. This includes managing multiple complex projects, troubleshooting issues, and fostering collaboration with business partners and stakeholders to ensure the continuation of supply in all markets. The Quality Manager will also be responsible for overseeing and managing the end-to-end product disposition process for Finished Goods. This role ensures timely and compliant product release by overseeing data readiness and collaborating with Contract Manufacturing Organizations (CMOs) and internal teams to implement continuous improvement measures. The position reports to the Associate Director and plays a critical role in driving quality initiatives and maintaining the integrity of deliverables KEY RESPONSIBILITIES Key Responsibilities of the position may include, but are not limited to the following: Product Disposition Management Oversee product disposition for Finished Goods, ensuring compliance with regulatory and quality standards. Collaborate with Contract Manufacturing Organizations (CMOs) to resolve disposition-related issues and align on timelines and quality expectations. Review of Executed Batch Records (EBRs) for commercial packaging operations and resolution of comments with CMOs Review of impacting change controls against full lot genealogy to determine if material is compliant in relevant region(s), make disposition decision, and perform batch release Evaluations of Investigations/ OOS/ Change Controls to support Disposition Decision Assist with EAC and Material Review Board activities, when necessary Manage data readiness for product disposition, including batch records, Certificates of Analysis (CoA), and supporting documentation. Proactively manage and improve disposition processes to meet turnaround times. Stakeholder Collaboration Develop and manage relationships with strategic external partners in support of Vertex’s expanding commercial portfolio and manager ongoing relationships. As CMO lead, be responsible for management of QA relationships with one or more CMOs. Act as the primary QA contact for disposition-related queries and escalations. Collaborate with internal teams (e.g. MS&T, External Manufacturing, Supply Chain, Regulatory) to ensure alignment and timely resolution of quality events. Compliance and Continuous Improvement Provide quality guidance for root-cause analysis, product impact assessments, and CAPA actions. Support GMP/GDP management reviews, risk assessments, and mitigation strategies. Identify and implement process improvements to enhance internal QA processes as well as Vendor performance. Lead and / or represent FG QA in cross-functional initiatives / continuous improvement projects. Communication Prepare and present (as needed) operational and quality reports, including disposition performance metrics, trends, risks, and mitigation plans. Provide regular updates on disposition activities, CMO management and improvement initiatives. Audit and Inspection Support Serve as SME responder and provide support for audit/inspection preparation, execution, and post-inspection activities. MINIMUM QUALIFICATIONS: Bachelor’s degree in Life Sciences, Pharmacy, or a related health field. 4+ years of experience in pharmaceutical manufacturing (Packaging and Labelling Operations preferred), quality assurance, or Finished Goods product disposition. Strong knowledge of global GMP requirements and oral drug product manufacturing practices. Proficiency in data analysis and visualization tools. Excellent communication, collaboration, and project management skills. PREFERRED QUALIFICATIONS: Strong leadership skills with the ability to thrive in a high throughput environment Attention to detail Critical Thinking / Problem Solving Ability to evaluate quality matters and make decisions utilizing risk-based approach Project Management / Continuous Improvement o Ability to lead and manage projects/teams within corporate objectives and project timelines o Proficient in utilizing project management processes / tools to lead meetings, assist with project planning, and facilitate completion of tasks o Demonstrated ability to work independently to provide QA support for large, multifaceted projects Collaboration / Teamwork / Conflict Management o Ability to independently lead cross-functional teams and represent the Quality unit o Ability to understand and translate business needs o Recognized as a mentor with a strong ability to transfer technical knowledge and teach skills to junior staff o Represents Vertex Commercial Quality Assurance on cross functional working teams and is recognized for strong communication and influencing skills Flexibility/Adaptability Knowledge in the following areas: o Expert knowledge of global GMP requirements governing oral drug products and knowledge of oral drug product manufacturing practices o GMP/GDP regulations and application to Manufacturing and Testing risk management principles o Root Cause Analysis tools/methodology Broad GxP Knowledge and understanding across lifecycle of the product Sense of urgency - ability to act quickly/escalation process/transparency Pay Range: $118,400 - $177,600 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 View email address on click.appcast.io 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 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.