Director, Clinical Quality Assurance - New Haven - Celldex

    Celldex
    Celldex New Haven

    1 week ago

    $176,659 - $229,427 (USD) per year
    Description

    Director, Clinical Quality Assurance


    Join to apply for the Director, Clinical Quality Assurance role at Celldex

    Celldex is a clinical-stage biotechnology company dedicated to developing novel antibody-based treatments that improve the lives of patients with allergic, inflammatory, and autoimmune disorders. The Director of Clinical Quality Assurance will provide thorough knowledge of GCP Quality, strong leadership and clinical development experience to support Celldex's expanding portfolio. This role will involve ongoing interaction with internal project team members, vendors, and partners, influencing these internal and external stakeholders to successfully embed a robust GCP Quality Assurance culture.

    Responsibilities

    • Execute and oversee the clinical development oversight program across Clinical, Medical and Regulatory, and implement quality practices throughout clinical trial execution
    • Participate in the establishment, maintenance and improvement of the Clinical Quality Management System and associated practices
    • Determine, evaluate and investigate GCP Quality Events, adequacy of reporting and the potential impact on the study
    • Lead Celldex GCP Inspection Readiness activities
    • Provide leadership in GCP inspections performed by FDA and international regulatory agencies; also, audits performed by partners
    • Proactively identify analyses and leverage quality indicators and data for potential trends and risks to address and complete risk-based QA assessments and to support the implementation of associated risk mitigation strategies
    • Provide business-level leadership, foster best practices, and mentor and consult on GCP compliance techniques across the development and operations organizations
    • Manage the process for documenting Process Deviations, Quality Issues, and CAPAs
    • Develop and support the issuance of Controlled Documents (e.g., Policy, SOPs, KPIs)
    • Provide suggestions for continuous quality improvement in GxP and, specifically, GCP
    • Maintain expert up-to-date knowledge on GCP legislation and relevant parts of GxP guidelines and practices and ensure that the information is distributed and acknowledged by relevant departments within Celldex
    • Responsible for QA review of key study documentation, SOPs, Vendor documentation, and relevant submission documentation

    Qualifications

    • Bachelor's degree (or higher) in a relevant field. Concentration in a scientific or health care field preferred.
    • 7-10 years of experience in the pharmaceutical or life sciences industry, with a strong focus on GCP Quality Management and clinical quality leadership roles
    • In-depth knowledge of FDA, EU and ICH guidelines for clinical research
    • Proven track record managing GCP audits, health authority inspections, and inspection readiness
    • Experience in Quality Risk Management for clinical trials and implementation of quality plans
    • Excellent interpersonal and communication skills with the ability to work in a fast-paced, collaborative environment
    • Strong leadership skills
    • Ability to work both independently and within a matrix organization
    • Strategic mindset with strong problem‑solving abilities
    • Organized and detail-oriented, with excellent planning capabilities
    • Adaptability to changing priorities and deadlines

    Seniority level

    • Director

    Employment type

    • Full‑time

    Job function

    • Quality Assurance

    Compensation


    The expected base salary range for this position is $176,659 to $229,427.

    We are committed to compensating employees equitably based on several factors including experience, education, licensure/certifications, skill level, location of the position, and availability of similar talent in a competitive market.

    Compensation for this role includes base salary, annual discretionary bonus, long-term incentive plan, 401(K) plan with employer contribution, health care and other insurance benefits (for employee and family), paid holidays, vacation, and sick days. A summary of our benefits can be found on our careers page.

    EEO Statement


    Celldex is proud to be an equal opportunity employer that strives to foster a culture of diversity, equity, and inclusion. We are committed to promoting a diverse environment through development, recruiting and community outreach.


    #J-18808-Ljbffr

  • Work in company

    Quality Assurance Specialist

    Only for registered members

    We opened our doors with a clear and simple vision: to provide the worldwide clinical research industry with professional services that demonstrate the highest level of experience, quality, and integrity. Since 1996, ProTrials has supported research that has led to ground-breakin ...

    Regional $65,000 - $110,000 (USD) per year

    1 week ago

  • Work in company

    Quality Assurance Specialist

    Only for registered members

    We are passionate about dermatology and improving the lives of individuals suffering from common skin conditions. The therapeutics you help us develop will impact the quality of life of millions of people suffering from conditions ranging from common warts to alopecia areata. · O ...

    New Haven, CT

    1 month ago

  • Work in company

    Quality Assurance Analyst

    Only for registered members

    We are currently supporting an early-stage life sciences organization that is expanding its quality infrastructure. · About the Role · This is a great opportunity for a junior-to-mid-level QA professional who enjoys working in a fast-moving build-phase environment and wants meani ...

    New Haven $55,000 - $95,000 (USD) per year

    2 weeks ago

  • Work in company

    Quality Assurance Analyst

    Only for registered members

    We are currently supporting an early-stage life sciences organization that is expanding its quality infrastructure. · We are looking to bring on a Contract QA Analyst to support near-term program growth. · This is a great opportunity for a junior-to-mid-level QA professional who ...

    New Haven County, CT $55,000 - $95,000 (USD) per year

    2 weeks ago

  • Work in company

    Quality Assurance Technician

    Only for registered members

    This role is open to US citizens or Permanent Residents located within a daily commuting distance of West Haven, Connecticut. · Join a team that values our greatest resource, our employees. It is an excellent opportunity to work with multiple award winners, paradigm shifters, and ...

    West Haven $55,000 - $65,000 (USD)

    1 week ago

  • Work in company

    Director, Clinical Quality Assurance

    Only for registered members

    +Celldex is a clinical-stage biotechnology company dedicated to developing novel antibody-based treatments that improve the lives of patients with allergic inflammatory autoimmune disorders+Bachelor s degree (or higher) in relevant field Concentration in scientific or health care ...

    New Haven, CT

    3 weeks ago

  • Work in company

    Software Quality Assurance Tester

    Town Fair Tire

    *This is an on-site role based in East Haven, CT. Candidates must live within commuting distance and be authorized to work in the U.S.* · Summary: · Town Fair Tire is seeking a highly motivated Quality Assurance Tester to join a mid-sized team of · Software Developers, Data Scien ...

    New Haven

    13 hours ago

  • Work in company

    Senior Quality Assurance Engineer

    Only for registered members

    The Senior Quality Assurance Engineer ensures the quality, reliability, and security of enterprise applications and services in a rapidly evolving digital landscape. · Qualifications6+ years of QA experience in Agile, cloud-native, and story-driven environments. · Expertise in te ...

    New Haven, CT

    1 month ago

  • Work in company

    Food Safety, Quality Assurance

    Only for registered members

    + Job summary: Working at Yale means contributing to a better tomorrow. Whether you are a current resident of our New Haven-based community-eligible for opportunities through the New Haven Hiring Initiative or a newcomer interested in exploring all that Yale has to offer your tal ...

    New Haven $68,000 - $120,500 (USD)

    1 month ago

  • Work in company

    Software Quality Assurance Tester

    Town Fair Tire

    *This is an on-site role based in East Haven, CT. Candidates must live within commuting distance and be authorized to work in the U.S.* · Summary: · Town Fair Tire is seeking a highly motivated Quality Assurance Tester to join a mid-sized team of · Software Developers, Data Scien ...

    East Haven

    13 hours ago

  • Work in company

    Quality Assurance Team Lead

    Only for registered members

    We are seeking a Quality Assurance (QA) Lead who will support Embedded Systems and Firmware. · ...

    New Haven County, CT

    1 month ago

  • Work in company

    Food Safety, Quality Assurance

    Only for registered members

    The Food Safety Specialist provides operational oversight and strategic leadership for all aspects of food safety across Yale Hospitality's residential dining retail catering and bakery operations. · Develop implement and maintain an enterprise-wide food safety program grounded i ...

    New Haven, CT

    1 month ago

  • Work in company

    Quality Assurance Specialist

    Only for registered members

    Job Title: Quality Assurance Compliance Specialist · Department: Quality Assurance · Reports To: Director, Quality Assurance and Regulatory Affairs · FLSA Status: Exempt · Work Schedule: Monday–Friday · Position Purpose · The Quality Assurance Compliance Specialist is a key membe ...

    East Haven, CT $65,000 - $110,000 (USD) per year

    1 week ago

  • Work in company

    Quality Assurance Lab Technician

    Only for registered members

    We are seeking a detail-oriented and highly skilled Quality Assurance Technician to join our team.This position involves utilizing various inspection tools and techniques to verify product specifications,maintain compliance with industry standards,and contribute to continuous imp ...

    West Haven

    1 month ago

  • Work in company

    Quality Assurance Manager

    Only for registered members

    This position is a Key Leadership role responsible for managing the activities of the Quality Assurance Department ensuring that goals and objectives are met in support of the Company's AS9100 and ISO 9001:2000 Quality Management System. · Manage daily operation of Incoming In pr ...

    New Haven County, CT

    1 month ago

  • Work in company

    Associate Director, Quality Assurance Operations

    Only for registered members

    We take those numbers very seriously and we come to work each day on a mission to deliver protection from serious viral infectious diseases. · Be part of making a difference. Be part of Invivyd. · Review and approve relevant GMP documents for compliance to Invivyd's Quality Manag ...

    New Haven

    1 month ago

  • Work in company

    Quality Assurance Laboratory Technician

    Only for registered members

    This role is open to US citizens or Permanent Residents located within a daily commuting distance of West Haven Connecticut.Join a team that values our greatest resource our employees It is an excellent opportunity to work with multiple award winners paradigm shifters and industr ...

    West Haven $50,000 - $55,000 (USD)

    2 weeks ago

  • Work in company

    Quality Assurance Specialist|ALX|US

    Only for registered members

    We are looking for a strong analytical candidate with quality assurance experience and a background in clinical testing. As Analytical Sciences Quality Lead, you will provide quality partnership and oversight to the Product Development Clinical Supply (PDCS) at the New Haven site ...

    New Haven

    1 month ago

  • Work in company Remote job

    Associate Director, Quality Assurance Operations

    Only for registered members

    Be part of making a difference. Be part of Invivyd. · ...

    New Haven, CT

    1 month ago

  • Work in company

    Senior Director, Chemistry Quality Assurance

    Only for registered members

    We are looking for an experienced Senior Director of Chemistry Quality Assurance to lead in GMP chemistry quality oversight across Invicro radiopharmaceutical manufacturing in New Haven, CT, · US and London, · UK.The role will be responsible for collaborating with research partne ...

    New Haven

    1 month ago

  • Work in company

    Software Quality Assurance Tester

    confidential

    *Summary:* · Read the overview of this opportunity to understand what skills, including and relevant soft skills and software package proficiencies, are required. · We are seeking a highly motivated Quality Assurance Tester to join a mid-sized team of Software Developers, Data Sc ...

    New Haven

    5 days ago

Jobs
>
Director, clinical quality assurance
>
Jobs for Director, clinical quality assurance in New Haven