Quality Systems Manager

Job Description JOB TITLE: Quality Systems Manager LOCATION: 50 Northern Ave., Boston, Massachusetts 02210 OPENINGS: 1 DUTIES: Collaborate with internal and external business partners and cross-functional teams to resolve complex quality and operational issues, ensuring compliant and efficient solutions. Draft, review, and maintain process-specific Standard Operating Procedures (SOPs) and Work Instructions to ensure they remain compliant and up to date. Analyze workflows, quality systems, and production processes to identify inefficiencies, compliance gaps, and areas for continuous improvement. Develop and implement effective solutions, encompassing enhancements to cross-functional quality systems and operational processes, ensuring adherence to industry standards and regulations including 21 CFR Parts 4 and 820, ISO 13485, and ISO 14971. Participate as a technical resource in cross-functional teams, providing expertise in quality investigations, deviations, and operational issues. Conduct thorough root cause analyses and product impact assessments for investigations resulting from deviations, OOS, or operational inefficiencies, and propose corrective and preventive action plans (CAPAs). Approve investigations, CAPAs, and change controls, and assist Change Control owners in ensuring compliance with change procedure requirements. Support vendor quality management activities, including evaluating vendor quality systems and assisting in resolving vendor-related quality issues. Design and implement metrics and reporting systems using tools including Power BI to analyze data, identify trends, and guide decision-making. Drive continual improvement initiatives through Lean, Six Sigma, and other quality and operational methodologies. Develop, maintain, and deliver training curricula for team members, providing guidance on compliance, quality standards, and operational best practices. Identify risks in quality systems and production processes, communicate them effectively to stakeholders, and assist with risk mitigation plans. Coordinate and follow up on management action items, and ensure timely completion of assigned tasks. REQUIREMENTS: Employer will accept a Bachelor’s Engineering, Life Sciences, Industrial and Technical Studies, or a related field and 5 years of experience in the job offered or in Quality Systems Manager-related occupation. Position requires demonstrable experience in the following: A minimum of 3 years of experience in the medical devices field. In-depth knowledge of both the conceptual and practical application of cGMPs in a medical device setting, as well as knowledge of global GMP requirements and the ability to provide quality oversight, guidance, and compliance support to GMP manufacturing operations. In-depth experience leading complex projects and teams and continuous improvement initiatives within stated objectives and timelines; effectively apply project management processes and tools to plan deliverables, track progress, lead project meetings, and ensure timely completion of milestones. Facilitate collaboration between departments and setting clear quality expectations during risk-based decision making, effectively representing the Quality unit. Experience leading event investigations, Root Cause Analysis (RCA), and corrective and preventive action plans (CAPAs). Experience working with electronic management systems, including Veeva, to manage workflows related to document management systems, including SOPs, and Work Instructions. Experience examining deviations and CAPA processes to ensure timely review and closure. Rate of Pay: $134202.00 - $164400.00 CONTACT: Send Resume to futuretalent@vrtx.com. Reference 12140.619. EOE. #LI-DNI Pay Range: $109,600 - $164,400 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.