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Vertex Inc.
Boston, Massachusetts, United States • Hybrid
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Provide quality leadership and oversight for assembly manufacturing operations of medical devices and combination products. Manage product disposition, batch record reviews, deviations, CAPAs, and partner with CMOs to ensure regulatory compliance.
Requires a Bachelor's degree in Engineering or Life Sciences with 10+ years of quality experience in the medical device or pharmaceutical industry. Must have at least 5 years of experience supporting GMP manufacturing operations and drug-device combination products.
General Summary
The Operational Area Quality Senior Manager provides quality leadership for assembly manufacturing operations supporting medical device and combination products. The role is responsible for quality oversight of manufacturing operations, product disposition, batch record review, deviations, investigations, CAPAs, change controls, supplier quality, and regulatory compliance while partnering with manufacturing, engineering, supply chain, and external manufacturing partners. The position also supports design quality activities to ensure manufacturing changes remain aligned with design control and risk management requirements throughout the product lifecycle.
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Key Duties and Responsibilities
- Lead Quality Assurance support for assembly manufacturing operations of medical device and combination products, ensuring compliance with GMP, regulatory requirements, and internal quality systems.
- Provide quality oversight for product disposition activities, including review and approval of manufacturing documentation to support timely release of clinical and commercial product.
- Review and approve Manufacturing Batch Records (MBRs), Electronic Batch Records (EBRs), Device History Records (DHRs), and associated manufacturing documentation.
- Lead and approve manufacturing deviations, investigations, nonconforming material reports (NCMRs), CAPAs, change controls, and effectiveness checks.
- Conduct and lead root cause investigations using structured problem-solving methodologies and ensure implementation of effective corrective and preventive actions.
- Support manufacturing operations by providing real-time quality oversight for assembly processes, equipment issues, process improvements, and manufacturing investigations.
- Partner with Contract Manufacturing Organizations (CMOs) to ensure compliance with Quality Agreements, disposition requirements, manufacturing investigations, and continuous improvement initiatives.
- Support manufacturing process validation, equipment qualification, technology transfers, and process improvements to ensure products remain in a validated state.
- Lead supplier quality activities including supplier investigations, supplier change assessments, supplier qualification, and quality issue resolution.
- Support regulatory inspections, customer audits, supplier audits, and internal audits while ensuring timely responses and closure of observations.
- Support complaint investigations and product quality assessments as required.
- Support Design Quality activities by reviewing design changes, participating in design reviews, supporting Design History File maintenance, and ensuring manufacturing changes are appropriately evaluated through design controls and risk management.
- Provide input into risk management activities, including DFMEA, PFMEA, hazard analyses, and Risk Management Files, to ensure manufacturing risks are appropriately evaluated throughout the product lifecycle.
- Promote continuous improvement initiatives to enhance manufacturing quality, compliance, operational efficiency, and product reliability.
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Knowledge and Skills
- Strong experience supporting assembly manufacturing operations for medical devices and combination products.
- Demonstrated experience reviewing and approving MBRs, EBRs, DHRs, product disposition, manufacturing investigations, CAPAs, deviations, change controls, and nonconforming material records.
- Strong knowledge of autoinjector and drug-device combination products, including assembly processes, manufacturing operations, supplier management, and product lifecycle support.
- Demonstrated knowledge of GMP, 21 CFR Part 820, 21 CFR Part 4, ISO 13485, ISO 14971, and applicable combination product regulations.
Experience supporting process validation, equipment qualification, technology transfers, and manufacturing readiness.
- Experience working with Contract Manufacturing Organizations (CMOs) and external suppliers.
- Working knowledge of Design Controls and Risk Management to support manufacturing quality activities and lifecycle changes.
- Strong technical problem-solving, investigation, and root cause analysis skills.
- Excellent leadership, communication, and cross-functional collaboration skills.
- Experience with statistical analysis tools, Minitab, and quality engineering methodologies preferred.
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Education and Experience
- Bachelor’s degree in Engineering, Life Sciences, Quality, Manufacturing, or a related technical discipline is required. Advanced degree preferred.
Typically requires 10+ years of Quality Assurance, Quality Engineering, Manufacturing Quality, or Operations Quality experience within the medical device, biotechnology, pharmaceutical, or combination product industry.
- Minimum of 5 years supporting GMP manufacturing operations, including assembly manufacturing, product disposition, deviation management, investigations, CAPA, change control, and batch record review.
- Demonstrated experience supporting autoinjector, prefilled syringe, or other drug-device combination products from clinical through commercial manufacturing.
- Experience leading cross-functional quality initiatives and partnering with Contract Manufacturing Organizations (CMOs) and suppliers.
- Prior people leadership or demonstrated technical leadership of complex quality programs is preferred
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.
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
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 [email protected]
Together we deliver connected solutions to conquer tax complexity.
The rapid changes taking place in today’s global business, technology, and regulatory environments are having a compounding effect on the complexity of indirect tax management and putting more pressure on the corporate tax function than ever before. This complexity demands intelligent solutions that enable businesses to satisfy tax obligations and support growth opportunities. The Trusted Leader in Tax Technology We're Vertex (VERX). A pioneer in tax automation for more than 40 years. We proudly serve over 4,000 customers worldwide with distinction and provide comprehensive tax solutions that enable global businesses to transact, comply and grow with confidence. Our software, content and services address the increasing complexities of global commerce and compliance by reducing friction, enhancing transparency and enabling greater confidence in meeting indirect tax obligations. As a result, our software is ubiquitous within our customers’ business systems, touching nearly every line item of every transaction that an enterprise can conduct. Our software is fueled by over 300 million data-driven effective tax rules and supports indirect tax compliance in more than 19,000 jurisdictions worldwide. We partner with the world’s most respected companies and harness their strengths to deliver the best tax technology solution to businesses across the globe. We integrate with key technology partners that span ERP, CRM, procurement, billing, POS and e-commerce platforms. We also work closely with over 50 tax, accounting and consulting firms to provide the integrated tax technology solutions. Our culture is the foundation of everything we do, guided by a common purpose to build trusted relationships at work, in business and in our communities. We strive to be a values-driven employer of choice who attracts, retains and inspires talented professionals to achieve their full potential. We employ over 1,100 full-time professionals today in the US, Europe and Brazil.
Offices: 2301 Renaissance Blvd, King of Prussia, PA 19406, US · 40 Shuman Blvd., Suite 218, Naperville, IL 60540, US · 1 Furzeground Way, Stockley Park, Stockley Park, Uxbridge UB11 1EZ, GB · 101 Arthur Andersen Parkway, Suite 300, Sarasota, FL 34232, US · Gustav Mahlerplein, Amsterdam, North Holland 1082, NL
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