Current jobs related to Lead Quality Assurance Strategist - Saugus, Massachusetts - TerSera Therapeutics LLC

  • UX Quality Assurance Specialist

    3 weeks ago

    Saugus, Massachusetts, United States CHAMPRO Full time

    {"h1": "Job Title: UX Quality Assurance Tester", "h2": "Job Summary", "p": "Champro is seeking a skilled UX Quality Assurance Tester to ensure seamless customer interactions across digital platforms. This role involves monitoring and resolving customer experience (CX) issues, testing new digital features, and leading various digital projects. The ideal...

  • Digital Marketing Strategist

    3 weeks ago

    Saugus, Massachusetts, United States Swoon Full time

    Job OverviewSwoon is seeking a skilled Marketing Campaigns Manager to lead the development of digital communication strategies for a major digital bank in the US.Location: Riverwoods, IL (Hybrid)Duration: 6 Months (possible extension)Pay Rate: $74/hKey ResponsibilitiesAs a Marketing Campaigns Manager, you will be responsible for:Managing schedules and...

  • Senior Principal Engineer, Product Quality Cybersecurity Expert

    2 weeks ago

    Saugus, Massachusetts, United States Baxter International Full time

    Job SummaryBaxter International is seeking a highly skilled Sr. Principal Engineer, Product Quality Cybersecurity to join our team. As a key member of our Quality organization, you will play a critical role in ensuring the development and maintenance of our products meet regulatory standards, particularly in the realm of cybersecurity.Key...

  • Lead Teacher

    2 weeks ago

    Saugus, Massachusetts, United States The Goddard School of Deerfield (Northbrook), IL Full time

    Job SummaryWe are seeking a highly motivated and experienced Lead Teacher to join our team at The Goddard School of Deerfield (Northbrook), IL. As a Lead Teacher, you will be responsible for coordinating the daily operations of assigned classes, planning and presenting educational and recreational activities, and providing quality customer service to...

  • Production Team Lead

    1 week ago

    Saugus, Massachusetts, United States Holcim Full time

    We are seeking a seasoned Production Team Lead to oversee the daily operations of our production team. In this role, you will be responsible for ensuring the efficient and safe execution of production activities, as well as the development and implementation of strategies to improve productivity and quality.As a Production Team Lead, you will be the primary...

  • Territory Sales Lead

    2 weeks ago

    Saugus, Massachusetts, United States Anderson Merchandisers Full time

    About the RoleWe are seeking a highly motivated and results-driven Territory Sales Lead to join our team at Anderson Merchandisers. As a Territory Sales Lead, you will be responsible for supervising and developing a team of sales associates to drive sales and meet retailer and client expectations.Key ResponsibilitiesBuild strong relationships with store...

  • Principal Product Owner

    2 weeks ago

    Saugus, Massachusetts, United States Discover Financial Services Full time

    Job DescriptionWe are seeking a highly skilled Principal Product Owner to join our team and lead the development of our Credit Card Disputes product. As a key member of our product team, you will be responsible for building and executing product roadmaps that support our disputes resolution strategy.Key ResponsibilitiesDevelop and maintain product backlogs,...

  • Lead Data Science Analyst

    3 weeks ago

    Saugus, Massachusetts, United States Discover Financial Services Full time

    Job Title: Lead Data Science AnalystAt Discover Financial Services, we're committed to creating a brighter financial future for our customers. As a Lead Data Science Analyst, you'll play a critical role in helping us achieve this goal.Job Summary:We're seeking a highly skilled and experienced Lead Data Science Analyst to join our team. In this role, you'll...

  • Lead Data Science Analyst

    2 weeks ago

    Saugus, Massachusetts, United States Discover Financial Services Full time

    Job Summary:We are seeking a highly skilled Lead Data Science Analyst to join our team at Discover Financial Services. As a key member of our analytics team, you will be responsible for leading the development and implementation of advanced analytics initiatives, including customer segmentation, optimization, and machine learning.Key Responsibilities:Lead...

  • Physical Therapist

    1 week ago

    Saugus, Massachusetts, United States Quality Rehab Management-Saugus-MA Full time

    Travel Rehabilitation Therapist PositionLocation: MassachusettsShift: 5x8 Any, 08:00:00-16:00:00, Duration 13 WeeksAt Quality Rehab Management, we offer a dedicated recruiter to help you navigate your career. Your recruiter will assist with resume fine-tuning, job placement, and housing needs. As a leading medical staffing company, we understand the...

  • Lead Retail Merchandising Specialist

    4 weeks ago

    Saugus, Massachusetts, United States Anderson Merchandisers, L.L.C. Full time

    Job Title: Lead Retail MerchandiserWe are seeking a highly motivated and experienced Lead Retail Merchandiser to join our team at Anderson Merchandisers, L.L.C.Job Summary:The Lead Retail Merchandiser will be responsible for supervising and developing a team of sales merchandisers to drive sales and meet retailer and client expectations. This role will also...

  • Physical Therapist

    2 weeks ago

    Saugus, Massachusetts, United States Quality Rehab Management-Saugus-MA Full time

    Travel Physical Therapist OpportunityWe are seeking a skilled Physical Therapist to join our team at Quality Rehab Management in Saugus, Massachusetts. As a travel Physical Therapist, you will have the opportunity to work in a variety of settings and gain valuable experience in rehabilitation therapy.About the Assignment:Location: Saugus, MassachusettsShift:...

  • Senior Software Design Engineer in Test

    1 week ago

    Saugus, Massachusetts, United States Walgreens Full time

    Job Description:Job SummaryLeads in testing activities to develop, execute and automate test plans on large, complex pre-release, upgrades and current versions of software that serve to provide desired functionality to the technology solutions and programs. Implements activities that generally impact multiple components / processes and the work more than one...

  • Clinical Supervisor

    1 month ago

    Saugus, Massachusetts, United States Eliot Community Human Services Full time

    Job SummaryEliot Community Human Services is seeking a skilled Clinical Supervisor to lead our Wraparound Services team. As a Clinical Supervisor, you will provide clinical interventions, supervision, and administrative oversight to assigned staff, ensuring the delivery of high-quality services to our clients.Key ResponsibilitiesProvide clinical...

  • Nuclear Medicine Technologist

    1 month ago

    Saugus, Massachusetts, United States AMEN CLINICS, INC., A MEDICAL CORPORATION Full time

    Job Title: Nuclear Medicine TechnologistAmen Clinics, Inc., a medical corporation, is seeking a skilled Nuclear Medicine Technologist to join our team. As a key member of our healthcare staff, you will be responsible for performing brain SPECT scans and related quality assurance procedures.Responsibilities:Perform brain SPECT scans and general quality...

  • Cardiac Technician

    4 weeks ago

    Saugus, Massachusetts, United States iRhythm Technologies Full time

    About this Role:iRhythm is seeking a skilled Certified Cardiac Technician to join our Clinical Operations team in Deerfield, IL. As a key member of our team, you will be responsible for reviewing patient ECG data and related algorithm findings for clinical accuracy and completeness. You will also communicate ECG abnormalities to physicians according to our...

  • Nuclear Medicine Technologist

    1 month ago

    Saugus, Massachusetts, United States AMEN CLINICS, INC., A MEDICAL CORPORATION Full time

    Job Title: Nuclear Scan TechnologistAmen Clinics, Inc., a medical corporation, is seeking a skilled Nuclear Scan Technologist to join our team. As a Nuclear Scan Technologist, you will play a critical role in providing high-quality patient care and contributing to the success of our outpatient healthcare clinics.Job Summary:The Nuclear Scan Technologist will...

  • Optometrist Team Lead

    2 weeks ago

    Saugus, Massachusetts, United States Pearle Vision Full time

    At Pearle Vision, we are dedicated to delivering exceptional service and high-quality eyewear to our valued patients. We pride ourselves on creating a welcoming environment where patients receive personalized attention and professional advice to meet their vision needs. As a growing practice, we are seeking a talented and enthusiastic Licensed Dispensing...

  • Practice Manager

    2 weeks ago

    Saugus, Massachusetts, United States Saugus Animal Hospital Full time

    Job DescriptionSaugus Animal Hospital is a well-established, full-service, AAHA accredited & Fear Free Certified small animal veterinary hospital providing comprehensive medical, surgical, and dental care. Our mission is to be there for our clients by providing unparalleled medical care in an atmosphere of uncompromising compassion so that our patients live...

  • Senior Land Surveyor

    2 months ago

    Saugus, Massachusetts, United States ATLAS ENGINEERING GROUP Full time

    Job OverviewPosition Title: Survey Project ManagerCompany: Atlas Engineering GroupAtlas Engineering Group is a reputable professional services firm with a strong presence in the engineering sector. We are currently seeking a Survey Project Manager to join our dynamic team. This role is ideal for a driven individual looking to advance their career within a...

Lead Quality Assurance Strategist

2 months ago

Saugus, Massachusetts, United States TerSera Therapeutics LLC Full time
Position Overview

Summary:

TerSera Therapeutics LLC is a dynamic and privately owned specialty pharmaceutical organization with a robust history of growth in the pharmaceutical industry. We are currently seeking a full-time Senior Quality Assurance Manager to support our expanding operations.

The Senior Quality Assurance Manager will report directly to the VP of Quality Assurance and will be tasked with overseeing designated quality management systems and quality operations activities within TerSera Therapeutics LLC.

This role involves managing TerSera's GxP vendors and contracted facilities, serving as the primary expert on quality standards for assigned products.

Key Responsibilities:

  • Supervise vendor relationships and collaborate with partners to address communications, resolve issues, and establish expectations and timelines.
  • Initiate and conduct investigations into product complaints, quality incidents, deviations, and CAPAs within the electronic Quality Management System (eQMS), ensuring prompt resolution through cross-functional collaboration.
  • Lead and participate in regular and ad-hoc meetings with contract facilities for assigned clinical and commercial products, representing the Quality Assurance function.
  • Review and approve executed manufacturing and packaging batch records, collaborating with contract facilities to resolve issues prior to batch or material disposition and performing batch release.
  • Conduct vendor qualifications, routine audits, and for-cause audits, documenting all audit activities in the Vault eQMS and tracking action items to closure.
  • Assist in hosting partner audits and regulatory inspections.
  • Compile, analyze, and present key performance metrics in preparation for management review meetings.
  • Maintain vendor performance dashboards and manage vendor risk assessments.
  • Create, review, and approve quality documents, including policies and procedures.
  • Execute additional projects as necessary to meet departmental and organizational objectives.
  • Conduct annual product review activities.
  • Review and draft vendor quality agreements.
  • Initiate, review, and approve change controls, performing QA impact assessments and coordinating timely completion of change actions.
  • Review and approve validation protocols, stability protocols, and other quality operations-related documentation.
  • Contribute to the preparation of regulatory submission documents and filings.

Non-Essential Functions:

  • Maintain a safe working environment by preventing accidents and ensuring safe working practices.
  • Exhibit a positive and professional demeanor towards all vendors, customers, partners, and colleagues.
  • Adhere to all policies and procedures established by TerSera Therapeutics.
  • Perform other duties as assigned.

Qualifications:

  • Extensive experience with Quality Management System elements, including Change Control, Deviation Management, Complaints, Supplier Qualification, and Document Control.
  • Strong background in solid dosage forms, aseptic fill-finish manufacturing, and combination product batch review and release.
  • Thorough understanding of FDA regulations (21 CFR 4, 11, 210 & 211) and EU Guidelines for Good Manufacturing Practices.
  • Proven ability to identify stakeholders and collaborate cross-functionally to resolve quality issues.
  • Strong analytical, problem-solving, and negotiation skills.
  • High adaptability and willingness to shift priorities as quality issues arise.
  • Excellent organizational skills, along with strong oral and written communication abilities, suitable for a fast-paced corporate environment.

Education and Experience:

  • Minimum: Bachelor's degree in a Life Science or Engineering discipline.
  • Required: At least eight (8) years of experience in quality assurance within the pharmaceutical sector.
  • Required: Experience managing outsourced cGxP activities.
  • Preferred: Auditor certification (ASQ or equivalent) or relevant auditing experience.
  • Preferred: Familiarity with Veeva Vault QualityDocs and eQMS suites or similar quality management systems.