Senior Supplier Quality Assurance Manager
3 weeks ago
Senior Supplier Quality Assurance Manager
About the job Senior Supplier Quality Assurance Manager
Responsibilities:
Manage systems and processes to oversee supplier quality, including handling the supplier change control system, supplier investigations, and supplier validation activities.
Oversee combination product development projects, ensuring compliance with quality standards and regulations.
Manage and oversee the change control system, including initiating and processing change controls for both internal and external modifications affecting materials, systems, and documentation.
Facilitate reviews and meetings for change control, tracking the implementation and closure of action items.
Support quality assurance operations by reviewing production records, testing documentation, and overseeing lot disposition activities to ensure compliance with quality agreements and GMP standards.
Conduct investigations into supplier and internal deviations, performing root cause analyses and developing corrective and preventive actions (CAPAs).
Serve as a lead on quality assurance for combination product projects, including managing risk assessments and maintaining design history files.
Author, review, and revise standard operating procedures (SOPs) and ensure all quality documentation complies with GMP, regulatory requirements, and corporate standards.
Assist in audit preparations and follow-ups, both internal and external, to maintain compliance standards.
Participate in and drive quality system improvements.
Qualifications:
Bachelors degree or higher in a technical or scientific discipline.
Minimum of 10 years' experience in a GMP-related field, with at least 7 years in quality assurance within the pharmaceutical or medical device industry.
Comprehensive knowledge of GMP requirements and regulatory standards including 21 CFR Parts 4, 210, 211, and 820.
Demonstrated understanding of manufacturing processes, technological transfers, and analytical testing in pharmaceutical and medical device contexts.
Strong capabilities in conducting detailed investigations, including root cause analysis and CAPA management.
Preferred Qualifications:
Experience with pharmaceuticals and medical devices strongly preferred.
Proficient in quality system regulations across multiple standards and guidances, such as ICH guidelines.
Exceptional communication and interpersonal skills to effectively interact at all organizational levels.
Proven ability to manage multiple priorities and timelines in a dynamic, fast-paced environment.
Strong organizational skills with an emphasis on detail and a commitment to high-quality work.
#J-18808-Ljbffr
-
Senior Supplier Quality Assurance Manager
4 weeks ago
Boston, United States Talnt LLC Full timeAbout the job Senior Supplier Quality Assurance Manager Responsibilities:Manage systems and processes to oversee supplier quality, including handling the supplier change control system, supplier investigations, and supplier validation activities.Oversee combination product development projects, ensuring compliance with quality standards and...
-
Senior Supplier Quality Assurance Manager
3 weeks ago
Boston, United States Talnt Full timeJob DescriptionJob DescriptionResponsibilities:Manage systems and processes to oversee supplier quality, including handling the supplier change control system, supplier investigations, and supplier validation activities.Oversee combination product development projects, ensuring compliance with quality standards and regulations.Manage and oversee the change...
-
Supplier Quality Specialist 3
1 month ago
Boston, United States Boeing Future of Flight Full timeSupplier Quality Specialist 3 (Contract) Contract (12 months) Published 2 days ago Procurement Processes Quality Systems Process analytical skills Quality Specialist - Eastern MA Plans and conducts audits and assessments of supplier's systems, processes and products. Documents and reports audit and assessment results. Inspects or verifies products for...
-
Senior Manager, IT Quality Assurance
3 days ago
Boston, United States Commonwealth Care Alliance Full timeWhy This Role is Important to UsThe Senior Manager, IT Quality Assurance is part of the Business Solutions team responsible for QA testing, product management and solutions delivery. This role is the primary owner for the QA Managed Services program and will be critical in the definition and implementation of our Enterprise QA program to supports CCA's...
-
Quality Assurance Manager
9 hours ago
Boston, United States The Brookline Center for Community Mental Health Full timeQUALITY ASSURANCE MANAGERIf you’re excited about driving change and passionately believe that all people deserve access to quality behavioral health care, we have an amazing opportunity for you! We’re looking for people who want to be part of a fast-paced and entrepreneurial team that is transforming a long-respected community mental health center into a...
-
Quality Assurance Manager
16 hours ago
Boston, United States The Brookline Center for Community Mental Health Full timeQUALITY ASSURANCE MANAGERIf you’re excited about driving change and passionately believe that all people deserve access to quality behavioral health care, we have an amazing opportunity for you! We’re looking for people who want to be part of a fast-paced and entrepreneurial team that is transforming a long-respected community mental health center into a...
-
Quality Assurance Coordinator
11 hours ago
Boston, United States Opis Senior Services Group Full timeLocation: Boston, MA - Hybrid of On-site/Remote Duration: 6 month - Contract to Hire Start: ASAP, Flexible Job Description: Our client, a major academic medical center in Boston and the nation's largest hospital based research program, is looking for a Quality Assurance Coordinator to join a major study group dedicated to the further research and care of...
-
Quality Auditor
4 weeks ago
Boston, United States SQA Services Full timeAre you passionate about quality in the life sciences area? Do you want to work with the most prestigious names in pharma, bio, animal health and similar regulated environments? If you have an eye for detail and want to help assure quality of life, then this is the role for you!What to expect:You will be part of a global quality auditing team responsible for...
-
Boston, United States Global Jupiter Full timeBy clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job...
-
Assurance Senior
7 days ago
Boston, United States Advisory Linx Full timeAdvisory Linx - Confidential Client Search Overview: Join our client’s rapidly growing assurance and advisory practice in Boston, MA! Assist domestic and global clients in numerous industries, including healthcare, technology, hospitality, consumer and industrial products, telecommunications, and financial services, among others. Find out exactly what...
-
Assurance Senior
4 weeks ago
Boston, United States Advisory Linx Full timeAdvisory Linx - Confidential Client Search Overview: Join our clients rapidly growing assurance and advisory practice in Boston, MA! Assist domestic and global clients in numerous industries, including healthcare, technology, hospitality, consumer and industrial products, telecommunications, and financial services, among others. The client is seeking highly...
-
Assurance Senior
2 weeks ago
Boston, United States Advisory Linx Full timeAdvisory Linx - Confidential Client SearchOverview: Join our client’s rapidly growing assurance and advisory practice in Boston, MA! Assist domestic and global clients in numerous industries, including healthcare, technology, hospitality, consumer and industrial products, telecommunications, and financial services, among others.The client is seeking highly...
-
Assurance Senior
1 month ago
Boston, United States Advisory Linx Full timeAdvisory Linx - Confidential Client SearchOverview: Join our client’s rapidly growing assurance and advisory practice in Boston, MA! Assist domestic and global clients in numerous industries, including healthcare, technology, hospitality, consumer and industrial products, telecommunications, and financial services, among others.The client is seeking highly...
-
Supplier Quality Engineer
4 weeks ago
Boston, United States Connected Systems Partners Full timeJob DescriptionJob DescriptionJob Location: Peabody MA areaThis Supplier Quality Engineer will assist in the supplier quality focused production goals of high volume electronics manufacturing. The hired individual will also focus on Process Engineering focused Manufacturing efforts as well.Professional Qualifications :1-5+ years of experience managing...
-
Supplier Quality Engineer
3 weeks ago
Boston, United States Connected Systems Partners Full timeJob Description Job Description Job Location: Peabody MA area This Supplier Quality Engineer will assist in the supplier quality focused production goals of high volume electronics manufacturing. The hired individual will also focus on Process Engineering focused Manufacturing efforts as well. Professional Qualifications : 1-5+ years of experience managing...
-
Sr Supplier QA Engineer
5 hours ago
Boston, United States Boston Scientific Gruppe Full timePress Tab to Move to Skip to Content Link Select how often (in days) to receive an alert: Create Alert The Sourced Finished Medical Device (SFMD) organization at Boston Scientific is a global, passionate team that oversees a diverse network of suppliers which manufacture finished devices for BSC distribution. The Senior Supplier Quality Engineer will...
-
Executive Director, Quality Assurance, GMP
4 days ago
Boston, United States Xenon Pharmaceuticals Inc. Full timeExecutive Director, Quality Assurance, GMP Boston, MA, USA Req #267 Monday, May 13, 2024 Who We Are: Who We Are: Xenon Pharmaceuticals (NASDAQ:XENE ) is a neuroscience-focused biopharmaceutical company committed to discovering, developing, and commercializing innovative therapeutics to improve the lives of people living with neurological and psychiatric...
-
Manager, Accounting Operations
1 day ago
Boston, United States Plymouth Rock Assurance Full timeOverview: Plymouth Rock Assurance is looking for an experienced Analytical Accounting professional who anticipates the changing needs of the business and effectively collaborates across teams to improve outcomes. They should establish effective operational finance processes and robust controls to deliver timely and insightful results. Strong communication...
-
Assurance Senior Manager
2 days ago
Boston, United States Marcum LLP Full timeAssurance Senior Manager - Boston page is loaded Assurance Senior Manager - Boston Apply locations Boston, MA time type Full time posted on Posted 2 Days Ago job requisition id R3789 Marcum LLP offers a great career with exceptional benefits. There’s a lot to think about when it comes to launching your career. At Marcum, we offer you a world of...
-
Senior Associate, Global Supplier Support
1 month ago
Boston, United States Wayfair Full time“The Desk” drives critical components of Wayfair’s supplier support strategy - our team members serve as the external ambassadors who support the supplier partners that feed Wayfair’s vast assortment, and leverage internal partners to execute our strategic vision of offering best-in-class support to an ever-growing supplier base. We are a positive,...