Sign up to access all features of our service.
  • Job search
  • Favorites
  • Create a CV
    New
  • Salaries
  • Subscriptions

Fractional GCP Quality & QbD Consultant (Risk-Based)

Penfield Search Partners Ltd

Penfield Search Partners Ltd in Boston area seeks an experienced GCP Quality / QbD Consultant to provide fractional support for clinical quality, risk assessment, and risk-based quality management across a clinical development program. This strategic governance role focuses on proactive risk identification, assessment, and mitigation, not traditional medical writing, with onsite workshops and cross-functional collaboration. #J-18808-Ljbffr Penfield Search Partners Ltd

Vacancy posted 5 days ago
Similar jobs that could be interesting for youBased on the Fractional GCP Quality & QbD Consultant (Risk-Based) in Boston, MA vacancy
  •  ...candidatesLocation: Boston, MAOur client is seeking an experienced GCP Quality / Quality by Design (QbD) Consultant to provide fractional support for clinical quality, risk assessment, and risk-based quality management across a clinical development program. This is a... 
    Risk
    Casual work

    Penfield Search Partners Ltd

    Boston, MA
    5 days ago
  •  ...Job Description Job Description Manufacturing & Quality Systems Gap Assessment Consultant Location: Onsite – Pennsylvania Work Arrangement...  ..., and relevant industry standards using a systematic, risk-based approach. The assessment will place particular emphasis... 
    Risk

    The FDA Group

    Boston, MA
    15 days ago
  • Beeline Medicines is seeking a Senior Director, GCP Quality Assurance to provide strategic leadership and operational oversight for GCP...  ...readiness. The role emphasizes senior QA leadership, risk-based quality management, and vendor governance, with potential travel... 
    Risk

    BioSpace

    Boston, MA
    3 days ago
  • Beeline Medicines Corporation is seeking a Senior Director, GCP Quality Assurance to lead strategic and operational GCP QA across clinical...  ...Operations, Regulatory Affairs, and CROs, you will drive risk-based quality management, vendor oversight, audit strategy, and the... 
    Risk

    Beeline Medicines Corporation

    Boston, MA
    4 days ago
  •  ...Remote50% Remote Job Description: The Quality Engineering and Validation Consultant is recognized as an expert...  ...change controls, validation protocols, risk assessments, GMP investigations and...  ...Analysis and CAPA Experience with network-based applications such as Veeva, Nuvolo,... 
    Risk
    Work experience placement
    Remote work
    Monday to Friday

    Katalyst Healthcares & Life Sciences

    Boston, MA
    1 day ago
  • Position Summary: The Senior Safety and Quality Consultant is a key member of the Division of Medical...  ..., work plans, milestones, deliverables, risks, and sustainability strategies; ensures...  ...this pay at the time of posting. Any base pay offer provided depends on skills, experience... 
    Risk
    Work at office
    Flexible hours

    Boston Children's Hospital

    Boston, MA
    2 days ago
  • $266k - $344k

     ...fully. Job Summary The Senior Director, GCP Quality Assurance provides strategic leadership and...  ...GCP quality systems, clinical quality risk management, CRO and vendor oversight, audit...  ...Additional on-site days may be required based on business needs, team priorities, or leadership... 
    Risk
    Local area
    Night shift
    2 days per week

    Beeline Medicines Corporation

    Boston, MA
    4 days ago
  • $60 - $65 per hour

    Overview Role: Validation & Quality Assurance Consultant (GMP) Location: Boston, MA (Onsite - Monday to Friday) Employment Type: Contract Status...  ...improvement through effective quality systems and risk-based decision-making. Key Responsibilities Provide QA oversight... 
    Risk
    Hourly pay
    Contract work
    Monday to Friday

    Jmd Technologies Inc

    Boston, MA
    7 days ago
  • $185k - $235k

    OverviewMonte Rosa Therapeutics is seeking a Director Quality GCP to provide strategic oversight of phase-appropriate Quality GCP and...  ...and key reviewer for other quality (GxP) procedures. Develop a risk-based GCP compliance program. Support teams in the initiation,... 
    Risk

    Monte Rosa Therapeutics

    Boston, MA
    4 days ago
  • $78.4k - $136.95k

     ...'s leading provider of ESG, Sustainability, EHS and Operational Risk Management Software. Enablon offers the most comprehensive platform...  ...ABM Marketing Manager to execute, optimize, and scale account-based marketing (ABM) programs and demand generation campaigns across... 
    Risk
    Full time
    Work at office

    Wolters Kluwer

    Boston, MA
    3 days ago
  •  ...Job Title : Fractional CISO Consultant Location: India (Remote) Duration: Ongoing Part-TimePosition...  ...with experience working with U.S.-based SaaS companies which are PE backed. The...  ...compliance, data privacy, and security risk management with a focus on global and... 
    Risk
    Part time
    Remote work

    Saviance

    Boston, MA
    4 days ago
  • Monte Rosa Therapeutics seeks a Senior Director/Director Quality GCP to provide strategic oversight of phase-appropriate GCP and GCLP...  ...cross-functional teams. The candidate will author SOPs, develop risk-based GCP programs, and lead inspection readiness while... 
    Risk

    Monte Rosa Therapeutics

    Boston, MA
    1 day ago
  •  ...Pharmaceuticals Incorporated seeks a Senior Manager, Clinical Study Quality Lead to provide study-level GCP QA oversight for assigned trials and partner with...  ..., CROs, and investigator sites. The role focuses on risk-based audit strategy, CAPA support, and inspection readiness... 
    Risk

    Vertex Pharmaceuticals Incorporated

    Boston, MA
    4 days ago
  • Moderna is seeking a Manager, Risk-Based Quality Management (RBQM) to drive risk-based quality initiatives in clinical trials, ensuring patient safety, data integrity, and regulatory compliance. The role partners with study teams, CROs, and Quality functions to implement... 
    Risk

    RXinsider LTD.

    Cambridge, MA
    1 day ago
  • $171.2k - $256.8k

     ...Massachusetts.SummaryThe Director, GCP & GLP QA, reporting to the Executive Director, Quality, is responsible for leading...  ...capabilities.Your RoleDefine and execute risk-based GCP audit strategy (CROs, sites...  ..., and processes)Provide QA consultation for protocol compliance, trial... 
    Risk
    Contract work

    Tango Therapeutics

    Boston, MA
    2 days ago
  • Monte Rosa Therapeutics, Inc. is seeking a Senior Director Quality GCP to provide strategic oversight of phase-appropriate Quality GCP...  ...continuous quality improvement. You will lead development of risk-based GCP programs, author SOPs, manage vendor qualification, audits... 
    Risk

    Monte Rosa Therapeutics, Inc

    Boston, MA
    2 days ago
  •  ...seeking a Senior Manager, Clinical Study Quality Lead to provide study-level quality oversight...  ...for assigned clinical trials, ensuring GCP compliance with global regulations, study...  ...across Vertex programs, including risk-based audit strategy, CAPA support, and inspection... 
    Risk

    Vertex Pharmaceuticals

    Boston, MA
    1 day ago
  • Vertex Pharmaceuticals seeks a Senior Manager, Clinical Study Quality Lead to provide study-level GCP QA oversight for assigned trials. This on-site or hybrid role requires hands-on experience with risk-based audit strategies, CAPA, and inspection readiness within... 
    Risk

    Vertex Pharmaceuticals

    Boston, MA
    1 day ago
  • Senior Director / Director - GCP Quality Monte Rosa Therapeutics is seeking a Senior Director / Director Quality GCP to provide strategic...  ...key reviewer for other quality (GxP) procedures. Develop a risk-based GCP compliance program. Support teams in the initiation,... 
    Risk

    Monte Rosa Therapeutics

    Boston, MA
    17 hours ago
  • $160k - $240k

     ...OverviewAs the Associate Director, GCP/GLP/GVP QA, you will oversee...  ..., ensure compliance and quality execution of clinical studies....  ...Proactively identify compliance issues/risks and recommend mitigations....  ...may be required. This role is based out of our corporate office in... 
    Risk
    Contract work
    Work at office
    Immediate start
    Night shift

    Rhythm Pharmaceuticals

    Boston, MA
    1 day ago
  • Position Summary The Lead Safety and Quality Consultant-Licensed is a senior, high-level individual contributor responsible for the strategic...  ...focus on the strategic roadmap, interdependencies, and proactive risk mitigation. Provides advanced clinical and operational... 
    Risk
    Work at office

    Boston Children’s Hospital

    Boston, MA
    1 day ago
  •  ...our growing team!This is an exciting home-based opportunity for clinical research professionals...  ...deviations appropriately per SOPs, GCP, and applicable regulatory requirementsOn-...  ...virtual/remote monitoring activities with a risk-based monitoring approach (including centralized... 
    Risk
    Contract work
    Work at office
    Remote work
    Work from home

    Medpace

    Boston, MA
    1 day ago
  • Senior Director, GCP Quality Oversight at Bicara Therapeutics Position Overview The Senior Director...  ...), and industry standards. This role is based in our Boston office and follows a hybrid...  ...identify potential internal or external risks to GCP compliance and develop mitigation... 
    Risk
    Contract work
    Work at office
    Local area
    3 days per week

    Bicara Therapeutics

    Boston, MA
    3 days ago
  • $134.5k - $265.1k

     ...Cyber Security practice as a GCP Forward Deployed Engineer, Senior Consultant and help organizations...  ...maintaining Terraform-based infrastructure-as-code, embedding...  ...attention to detail and quality of work productAbility to...  ...management of cyber risk. Our Forward Deployed Security... 
    Risk
    Local area
    Visa sponsorship

    Deloitte

    Boston, MA
    2 days ago
  •  ...Summary Just A Start is seeking a fractional Chief Technology Officer /...  ...on technology priorities, risks, investments, and opportunities...  ...to address them. Internal Consulting and Staff Support Serve as an...  ...365, Google Workspace, cloud‑based systems, endpoint/device management... 
    Risk
    Hourly pay
    Part time
    For contractors
    Remote work

    Just A Start

    Cambridge, MA
    1 day ago
  • $317.5k - $365k

     ...infrastructure through programmable money, blockchain-based payments, and cloud-native APIs. As VP, Global Head of Product Security & Risk, you will define and lead the enterprise...  ...native applications and services across AWS, GCP, or similar platforms.Demonstrated success... 
    Risk
    Worldwide
    Flexible hours

    Circle

    Boston, MA
    2 days ago
  •  ...vulnerabilities and configuration risks across on-premises, cloud, and...  ...and actionable, enabling risk-based prioritization and effective...  ...performance tuning, and data quality management.Tooling Integration...  ...cloud platforms (AWS, Azure, GCP) and hybrid infrastructures, with... 
    Risk

    eTeam

    Boston, MA
    5 days ago
  • $145k - $165k

     ...towards Geode’s overall Investment and Risk management.This role is based in our office in Boston,...  ...across passive portfolios.Establish data quality and readiness standards for accuracy,...  ...platforms such as Snowflake, AWS, Azure, or GCP.Expertise building and optimizing large... 
    Risk
    Work at office
    Remote work
    Monday to Friday

    Geode Capital Management

    Boston, MA
    6 hours ago
  • $213.6k - $320.4k

     ...Summary:The Senior Director, Global Quality Systems holds a pivotal...  ...assessment and control of QMS-level risks, drives a culture of quality...  ...experience (GMP and/or GCP with additional breadth preferred...  ...Statement:The range provided is based on what we believe is a... 
    Risk
    Full time
    Contract work
    Work experience placement
    Summer work
    Remote work
    Flexible hours
    2 days per week

    Vertex Pharmaceuticals

    Boston, MA
    2 days ago
  • $120k - $202.5k

     ...Engineering, Security Operations, Risk, Audit, and Compliance teams to...  ...outcomes.Establish and govern quality management and information security...  ...cloud operations (AWS/Azure/GCP), cloud-native platforms, SRE/DevOps practices, ITIL-based service management, operational... 
    Risk
    Full time
    Temporary work
    Work at office
    Local area
    Flexible hours
    Shift work
    2 days per week

    State Street Bank

    Boston, MA
    1 day ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Fractional GCP Quality & QbD Consultant (Risk-Based). Be the first to apply!