Director of GCP/QA

2 weeks ago

New York, United States Advanced Recruiting Partners Full time

Job Description

Determine risk-based intervals for audits of non-GMP vendors and ensure compliance with agreed-upon schedules

  • Conduct or assign the conduct of all scheduled non-GMP Vendor Qualification Audits, ensuring timely reporting and follow up
  • Serves as QA primary point of contact for designated clinical studies, attending routine update meetings and ensuring the actioning and completion of study-specific QA activities; provides QA review of project-specific planning documents, as needed, unless delegated
  • Ensures the implementation of a risk-based Clinical Quality Management Plan for all clinical studies intended for registration
  • Ensures the timely conduct, reporting, and follow up for non-GMP Internal QA Audits, as assigned, ensuring timely conduct, reporting, and follow up:
    • Schedule, conduct and provide timely reports of audits to assure conformance with the approved audit schedule, and to confirm compliance with regulations, guidelines, SOPs, and Industry standards
    • Effectively communicate actionable findings to various staff levels. Effectively present findings to ensure clear understanding of deficiencies (verbal and written)
  • Ensures clinical study protocols and reports are reviewed to assure quality, consistency, and compliance
  • Performs initial and/or technical review of draft GCP quality agreements prior to signatory review, as requested
  • Works to maximize the use of the electronic quality management system (eQMS) for quality workflows and for the effective tracking, trending, and reporting of quality data and information
  • Oversees the planning and performance of compliance audits of foreign and domestic clinical investigators to verify protection of human research participants, data integrity, and regulatory and protocol compliance
  • Writes, revises, and periodically reviews SOPs to further develop the Quality System and control over compliance and the quality of data, vendor services, and products
  • Ensures the timely and complete handling and documentation of quality incidents and investigations, root cause analyses, risk assessments and risk impact analyses, as well as corrective and preventive actions (CAPAs)
  • Clearly communicates quality, compliance, and audit issues to internal and external parties, professionally, and in a timely manner
  • Supports Regulatory Compliance and Inspection Activities:
    • Oversees the preparation of investigators and vendors for potential/impending audits and inspections
    • Conducts QA review of project-specific documents, as assigned
    • Supports the preparation, coordination, and management of regulatory agency inspections
  • Perform other quality assurance advisory duties as assigned by the Head of QA
Job characteristics:
  • Working independently in a geographically distributed team
  • Being proactive, target-driven, and diligent
  • Working with multiple stakeholders and managing multiple priorities
  • Contributing to an overall culture of quality within the organization
  • Participating in cross-functional conversations and decision-making around complex quality, compliance, and risk situations
  • Skilled in negotiation and communicating internally and externally with personnel of all levels of seniority
Requirements:
  • 8+ years working in GCP Quality Assurance and Quality Management
  • BA in scientific field, or BA in non-science field with additional 2 years relevant work experience
    • Advanced degree preferred
  • Documented training on and knowledge of current FDA Regulations and GCPs
  • Experience and expertise in conducting and reporting GCP vendor audits, clinical investigator audits, and protocol and report audits
  • Proficient written and verbal communication skills
  • Ability to collaborate effectively with cross functional team members and external partners
  • Ability to manage multiple QA activities across multiple programs and studies

  • Director/Senior Director Clinical Quality Assurance

    1 day ago

    New York, United States SciPro Inc. Full time

    A key client of ours in the CAR-T Cell Therapy space are looking for an experienced Director/Senior Director of Clinical Quality to join their team during an exciting growth phase! If you are passionate about making a difference in patients lives, and want to explore a new opportunity, look no further.... Responsibilities: Apply advanced, international...

  • Assistant Director

    1 week ago

    New York, United States Integrated Resources Full time

    Principal Duties: The QA Engineering Director will help drive continuous improvement and quality of data products that are leveraged across the enterprise to drive key business decisions, product direction and enable a great user experience. In this role The QA Engineering Director will demonstrate experience in software testing methodologies in a highly...

  • Clinical QA Manager

    7 days ago

    New York, United States PSG Global Solutions Full time

    Description We're looking for a Clinical QA Manager , working in Pharmaceuticals and Medical Products industry in 155 Tice Boulevard, Woodcliff Lake, New Jersey, 07677, United States . Job description: Chairs the Regulatory Authority Facilitation Team, and ensures that company clinical facility and clinical sites are prepared for clinical inspections and the...

  • QA Engineer

    5 days ago

    New York, United States Austin Fraser Full time

    The QA Engineer is a pivotal role within this organization, serving as the right-hand engineer to the Director of Engineering. This individual will spearhead quality assurance initiatives, collaborating closely with the director on test planning, strategies, and risk mitigation. With expertise in both hardware and software testing, particularly in embedded...

  • Quality Assurance Supervisor

    2 weeks ago

    New York, United States Meet Inc Full time

    Job Overview: The position entails joining a skilled QA team to oversee GLP audits and compliance for Preclinical and Bioanalytical groups, internal GLP/GCP testing, and overall GXP Quality System support. Responsibilities include conducting audits, managing GLP operations, reviewing data and documentation, and supervising QA Specialists....

  • Director / Sr. Director, Clinical Operations

    5 days ago

    New York, United States Klein Hersh Full time

    Our client is committed to identifying and advancing transformative therapies for people with cancer and rare diseases with limited treatment options. Role The Director/Sr. Director - Clinical Operations is responsible for providing leadership to assigned Clinical Program(s) and for ensuring studies (Phase I-IV) within a program are being managed in...

  • Dir, Clinical QA

    2 weeks ago

    New York, United States Zentalis Pharmaceuticals Full time

    Zentalis Pharmaceuticals is a San Diego based pharmaceutical company dedicated to the discovery and development of small molecule therapeutics targeting fundamental biological pathways of cancer. Since our inception, we have successfully cleared four INDs with the FDA. We believe our deep pipeline of oncology therapeutics has the potential to significantly...

  • Dir, Clinical QA

    1 month ago

    New York, United States Zentalis Full time

    Job DescriptionJob DescriptionSalary: $171k-$225kZentalis Pharmaceuticals is a San Diego based pharmaceutical company dedicated to the discovery and development of small molecule therapeutics targeting fundamental biological pathways of cancer. Since our inception, we have successfully cleared four INDs with the FDA. We believe our deep pipeline of oncology...

  • Senior Manager/Director of Quality

    4 weeks ago

    New York, United States HistoWiz Full time

    Job DescriptionJob DescriptionHistoWiz is the largest online histopathology company, based in New York City. Our mission is to help biomedical researchers find cures by accelerating histopathology and enabling global collaboration. We are looking for a Quality Assurance Specialist interested in joining our mission and serving the public health. This position...

  • Senior Medical Director

    4 days ago

    New York, United States Planet Pharma Full time

    Location: New York, NY. *Onsite 5 days per week. The office is located on Manhattan’s west side. This is an in-person position.Salary: $350K+Equity/BonusDirector of MedicalSeeking a seasoned Medical Director specialized in pharmacovigilance/drug safety and clinical development. A NYC-based growth-stage biopharmaceutical company in with an innovative...

  • Senior Medical Director

    3 days ago

    New York, United States Planet Pharma Full time

    Location: New York, NY. *Onsite 5 days per week. The office is located on Manhattan’s west side. This is an in-person position.Salary: $350K+Equity/BonusDirector of MedicalSeeking a seasoned Medical Director specialized in pharmacovigilance/drug safety and clinical development. A NYC-based growth-stage biopharmaceutical company in with an innovative...

  • Senior Medical Director

    3 days ago

    New York, United States Planet Pharma Full time

    Location: New York, NY. *Onsite 5 days per week. The office is located on Manhattan’s west side. This is an in-person position.Salary: $350K+Equity/BonusDirector of MedicalSeeking a seasoned Medical Director specialized in pharmacovigilance/drug safety and clinical development. A NYC-based growth-stage biopharmaceutical company in with an innovative...

  • Senior Medical Director

    7 days ago

    New York, United States Planet Pharma Full time

    Location: New York, NY. *Onsite 5 days per week. The office is located on Manhattan’s west side. This is an in-person position.Salary: $350K+Equity/BonusDirector of MedicalA NYC-based growth-stage biopharmaceutical company in with an innovative portfolio of novel, widely applicable therapeutic drug candidates, is seeking a Medical Director. The Director of...

  • Senior Medical Director

    6 days ago

    New York, United States Planet Pharma Full time

    Location: New York, NY. *Onsite 5 days per week. The office is located on Manhattan’s west side. This is an in-person position.Salary: $350K+Equity/BonusDirector of MedicalA NYC-based growth-stage biopharmaceutical company in with an innovative portfolio of novel, widely applicable therapeutic drug candidates, is seeking a Medical Director. The Director of...

  • Quality Assurance Automation Engineer

    3 weeks ago

    New York, United States Informatic Technologies, Inc. Full time

    One of our clients, a major in Financial Services is looking for a strong QA/Test Automation Engineer. This is a W2 only position and requires minimum 7-8 years of experience.Demonstrable experience of working in an Agile team as a QA/SET, collaborating with developers on test case definition, execution and automation.Proficient in Oracle Database...

  • Quality Assurance Automation Engineer

    3 weeks ago

    New York, United States Informatic Technologies, Inc. Full time

    One of our clients, a major in Financial Services is looking for a strong QA/Test Automation Engineer. This is a W2 only position and requires minimum 7-8 years of experience.Demonstrable experience of working in an Agile team as a QA/SET, collaborating with developers on test case definition, execution and automation.Proficient in Oracle Database...

  • Medical Director

    15 hours ago

    New York, United States Provider Healthcare Full time

    Job Type Full Time Schedule - Days Pay Negotiable Work Location Outpatient Clinic Job ID 60391 Job Description A New York City based client is seeking an excellent Primary Care Physician to serve as the Medical Director for a community health center. The Medical Director will provide ongoing development and review of protocols to ensure optimized care for...

  • Bilingual QA Support Aide

    4 weeks ago

    New York, United States Lutheran Social Services of New York - Safe Haven Full time

    Job DescriptionJob DescriptionPOSITION:  Bilingual QA Support Aide – Unaccompanied Minors ProgramREPORTS TO:  Quality Improvement Specialist Supervisor/Lead Case AideCLASSIFICATION:  Full Time              EXEMPT/NON-EXEMPT: Non-Exempt (Hourly)GENERAL DESCRIPTION: The Lutheran Safe Haven Shelter and Transitional Foster Care Program is a...

  • Bilingual QA Support Aide

    3 weeks ago

    New York, United States Lutheran Social Services of New York - Safe Haven Full time

    Job DescriptionJob DescriptionPOSITION:  Bilingual QA Support Aide – Unaccompanied Minors ProgramREPORTS TO:  Quality Improvement Specialist Supervisor/Lead Case AideCLASSIFICATION:  Full Time              EXEMPT/NON-EXEMPT: Non-Exempt (Hourly)GENERAL DESCRIPTION: The Lutheran Safe Haven Shelter and Transitional Foster Care Program is a...

  • Quality Assurance Director

    14 hours ago

    New York, United States Walter L. Shepeard Community Full time

    SUMMARY: The QA Director is responsible for developing, implementing, and monitoring a sound Quality Assurance Program for Shepeard Community Blood Center (SCBC). The primary responsibility is to ensure that the organization meets all regulatory requirements for collecting, manufacturing, and distributing blood products. ESSENTIAL DUTIES AND...