Current jobs related to Sr. Manager QA Quality Management Systems - Boston - Pharvaris

  • Quality Engineer, Systems

    3 weeks ago

    Boston, United States Connected Systems Partners Full time $100,000 - $120,000

    Job DescriptionJob DescriptionThis Quality (Systems) Engineer will play a vital role supporting the QMS, driving continuous improvements and ensuring compliance across a company that truly values quality. This position emphasizes addressing production issues and non-conformances, initiating enhancements, conducting root cause analyses, implementing...

  • Manager, Quality Systems

    1 month ago

    Boston, United States PepGen Full time

    Job DescriptionJob DescriptionManager, Quality Systems Position SummaryThe Manager Quality Systems will further develop and maintain the quality management systems supporting clinical trial activities within PepGen. Routine activities include development and maintenance of supplier management programs, including qualification assessments, auditing, quality...

  • Quality Engineering Manager

    4 days ago

    Boston, United States AppLab Systems, Inc Full time

    Quality Engineering ArchitectLocation: Boston MA (initial remote if fine for 1-2 months)Should have experience of working and leading Enterprise level QA / Test Automation teams with experience of performing Test automation transformations, defining strategies and driving technical initiatives in Enterprise level.Updated JDDetailed JD: 1. Good experience of...

  • Quality Engineering Manager

    5 days ago

    Boston, United States AppLab Systems, Inc Full time

    Quality Engineering ArchitectLocation: Boston MA (initial remote if fine for 1-2 months)Should have experience of working and leading Enterprise level QA / Test Automation teams with experience of performing Test automation transformations, defining strategies and driving technical initiatives in Enterprise level.Updated JDDetailed JD: 1. Good experience of...

  • Quality Management System Engineer

    3 weeks ago

    Boston, Massachusetts, United States Orbia Full time

    About Orbia Building & InfrastructureOrbia's Building & Infrastructure business, Wavin, is a leading provider of innovative solutions for the global building and infrastructure industry. With over 60 years of product development experience, we advance life around the world by building healthy, sustainable environments for global citizens.Our PurposeWe are...

  • Quality Management System Engineer

    2 weeks ago

    Boston, Massachusetts, United States Orbia Full time

    About Orbia Building & InfrastructureOrbia's Building & Infrastructure business, Wavin, is a leading provider of innovative solutions for the global building and infrastructure industry. With over 60 years of product development experience, we advance life around the world by building healthy, sustainable environments for global citizens.Our PurposeWe are...

  • IT Quality Assurance Manager

    3 weeks ago

    Boston Heights, United States Arhaus Full time

    The IT Quality Assurance (QA) Manager will lead the offshore QA team, ensuring the effectiveness of quality assurance processes and methodologies. This role is crucial for enhancing testing strategies, developing and maintaining quality and reliability testing systems, and managing resource planning for the organization’s IT systems and products.This...

  • Sr Project Manager

    1 week ago

    Boston, United States Softworld, a Kelly Company Full time

    Job Title: Sr Project ManagerJob Location: Dorchester MA 02125 RemoteOnsite Requirements:fluent in Spanishviso/ms projectfinancial/bankingJob Description: Manages the entire project lifecycle from project definition through implementation.Accountable for meeting agreed upon scope, cost, schedule and quality measures.Develops project plan and drives project...

  • Quality Control Manager

    4 months ago

    Boston, United States North Coast Seafoods Full time

    Job DescriptionJob DescriptionThe Quality Control Manager is responsible for managing all the quality aspects of their production facility and ensuring that all seafood products are manufactured in compliance with specific company Food Safety and QA requirements. They will manage a team of Quality Control Associates and Supervisors while working with...

  • Senior IT QA Analyst, Enterprise Business Solutions

    2 weeks ago

    Boston, United States Berkshire Hathaway Specialty Insurance Full time

    Job Opportunity:   Berkshire Hathaway Specialty Insurance (BHSI) has an exciting opportunity for an experienced IT Quality Assurance Professional to join our Boston based Information Technology Team. BHSI provides commercial property, casualty, healthcare professional liability, surety, executive, and professional lines insurance to global customers....

  • Quality Assurance Manager

    2 weeks ago

    Boston, United States USPRO Full time

    Quality Assurance ManagerBoston, MADirect HireQUAILITY ASSURANCE MANAGERSUMMARYThe Quality Assurance Manager provides leadership, direction and management of the company’s overall Quality Assurance and Food Safety program. They’re responsible for ensuring our seafood processing facilities operate in compliance with government food safety regulations and...

  • Quality Assurance Manager

    2 weeks ago

    Boston, United States USPRO Full time

    Quality Assurance ManagerBoston, MADirect HireQUAILITY ASSURANCE MANAGERSUMMARYThe Quality Assurance Manager provides leadership, direction and management of the company’s overall Quality Assurance and Food Safety program. They’re responsible for ensuring our seafood processing facilities operate in compliance with government food safety regulations and...

  • Quality Systems Manager

    3 weeks ago

    Boston, Massachusetts, United States Ironwood Pharmaceuticals Full time

    Company Overview:Ironwood Pharmaceuticals is a prominent global entity in the gastrointestinal (GI) healthcare sector, dedicated to enhancing the treatment of GI disorders and setting new benchmarks for patient care. We are at the forefront of developing innovative solutions such as LINZESS (linaclotide), the leading branded prescription in the U.S. for...

  • Quality Systems Manager

    3 weeks ago

    Boston, Massachusetts, United States PepGen Full time

    Job OverviewPosition Title: Manager, Quality SystemsRole SummaryThe Manager of Quality Systems is responsible for the ongoing enhancement and management of quality assurance frameworks that support clinical trial operations at PepGen. Key duties involve the development and upkeep of supplier management protocols, which encompass qualification evaluations,...

  • Quality Systems Manager

    3 weeks ago

    Boston, Massachusetts, United States PepGen Full time

    Job OverviewPosition Title: Manager, Quality SystemsRole SummaryThe Manager of Quality Systems is responsible for the ongoing development and oversight of quality management frameworks that support clinical trial operations at PepGen. Key responsibilities include the formulation and upkeep of supplier management initiatives, which encompass qualification...

  • Quality Systems Manager

    3 weeks ago

    Boston, Massachusetts, United States PepGen Full time

    Job OverviewManager, Quality SystemsPosition OverviewThe Manager of Quality Systems is responsible for the enhancement and upkeep of the quality management frameworks that support clinical trial operations at PepGen. Key responsibilities include the formulation and management of supplier oversight programs, which encompass qualification evaluations, audits,...

  • Senior IT QA Analyst, Enterprise Business Solutions

    1 week ago

    Boston, United States Berkshire Hathaway Specialty Insurance Full time

    Who are we? A strategic and trusted insurance partner, Berkshire Hathaway Specialty Insurance (BHSI), provides a broad range of commercial property, casualty and specialty insurance coverages and outstanding service to customers and brokers around the world. Part of Berkshire Hathaway’s insurance operations, we bring our solutions to market with our...

  • Sr. Account Manager

    4 months ago

    Boston, United States Mondo Full time

    Job DescriptionJob DescriptionApply now: Senior Account Manager, location is Boston, MA. The start date is ASAP for this full-time permanent positionJob Title: Senior Account ManagerLocation-Type: Boston, MA Onsite 3-4x a month (1x a week)Start Date Is: ASAPDuration: FTE PermanentCompensation Range: $100-130KJob Description:Must Haves:5 - 7+ years of...

  • Senior Quality Assurance Manager

    4 days ago

    Boston, Massachusetts, United States Commonwealth Care Alliance Full time

    Job Title: QA Test LeadCommonwealth Care Alliance is seeking a highly skilled QA Test Lead to lead our testing efforts for new software applications, system integrations, and upgrades across our technology platforms.Key Responsibilities:Develop comprehensive test plans, test cases, and test scripts based on business requirements, user stories, and technical...

  • Associate Director, Vendor Quality Management

    4 weeks ago

    Boston, United States Vertex Full time

    Job DescriptionGeneral Summary:The Associate Director, Vendor Quality Management is responsible for proactively and comprehensively monitoring vendor quality and compliance risk for vendors participating in GxP regulated environments across product modalities. This position is responsible for developing, maintaining, and disseminating vendor data and...

Sr. Manager QA Quality Management Systems

4 months ago

Boston, United States Pharvaris Full time

Pharvaris is a late-stage biotech company developing bradykinin B2 receptor antagonists for bradykinin-mediated diseases, with offices in Switzerland (Zug), the Netherlands (Leiden) and the USA (greater Boston area). We aim at bringing new, more convenient options to HAE patients who suffer sudden and prolonged attacks of swelling in multiple areas of the body including the airway, which can be life-threatening. We have a culture built on the core values of caring, trust, diversity and freedom and is driven by individuals committed to developing breakthrough therapies that have real impact on people’s lives. If you are looking for a place where your work can have meaning and you can make a difference – Pharvaris is the place for you.


We are now seeking a highly motivated and experienced Sr Manager, QA Quality Management Systems to join and help drive our development and compliance efforts.


Location

This role is based in the US (East Coast). Pharvaris supports its staff to be home based and work virtually.


General description

The Sr Manager QA Quality Management Systems reports to the Director Quality Management Systems Lead and works with the cross functional teams and applies in-depth knowledge and experience in Quality Systems and Compliance to streamline and strengthen the QMS with an immediate goal to become inspection ready for the lead product at Pharvaris.


Responsibilities


  • Support the GMP Quality Management System (QMS) processes and help drive continuous improvement activities to adapt to the requirements according to Pharvaris’ needs.
  • Collaborate cross functionally to administer and maintain the ACE electronic QMS (eQMS) system while ensuring compliance and efficiency.
  • Assist in the design, implementation, management, and improvement of the eQMS associated with GMP aspects of development such as change control, corrective and preventative actions (CAPAs), deviations, investigations, out of specification/out of trend investigations, vendor management, document control and training.
  • Responsible for QMS elements such as Document Management, Deviations, Change Control, CAPA, and Metrics.
  • Partner and facilitate coordination of change controls, deviations, CAPAs, and document workflows.
  • Support Quality Management in the development and implementation of training strategies and matrices to ensure personnel are appropriately trained to carry out their responsibilities.
  • Assist in the execution and the tracking of internal and external audits as needed.
  • Supports regulatory inspections or third-party audits.
  • Contributes to creation and continuous improvement of governance and procedural documents (e.g., quality manual, policies, and standard operating procedures.) Provides cross functional guidance on how to author, review, and approve procedures in the eQMS.
  • Assist in maintaining oversight of approved vendors and annual audit schedule.
  • Assist in the compilation of data to go into quarterly business management review presentations.
  • Works cross-functionally to establish and promote a healthy Quality culture throughout the organization.


Required Qualifications, working experience, competencies


  • BS/BA in a scientific, engineering discipline, or other related field (or equivalent level of training, education and experience) with at least 6 years’ experience in pharmaceutical / biotech industry within Quality Assurance
  • Working knowledge of relevant US, EU, and global regulations and guidance (ICH, ISPE, etc)
  • Experience implementing and improving quality systems applications, such as Electronic Document Management Systems (EDMS), Learning Management Systems (LMS), and Electronic Quality Management Systems (eQMS)
  • Has a strong understanding of relevant regulatory and compliance framework, and is familiar with global regulations and internationally recognized standards (e.g., FDA, EU, PIC/S, ISO)
  • Excellent interpersonal and negotiation skills, using a team-oriented approach to problem solving complex issues backed by scientific rationale
  • Outstanding communication skills (verbal and written) to all employee levels, executive leadership and external partners, suppliers, third parties, and industry organizations. English is company language.
  • Able to manage multiple projects and collaborate across various functional groups
  • Ability to thrive in a dynamic environment with high level of agility; a wide degree of creativity and strategic thinking is expected
  • Comfortable in a small company environment that is fast paced, challenging and where all leaders must take on a hands-on approach to get results
  • Ability to multi-task and manage workload independently