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
- ...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...RiskCasual work
- ...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
- 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
- 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
- ...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,...RiskWork experience placementRemote workMonday to Friday
- 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...RiskWork at officeFlexible hours
$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...RiskLocal areaNight shift2 days per week$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...RiskHourly payContract workMonday to Friday$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$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...RiskFull timeWork at office- ...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...RiskPart timeRemote work
- 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
- ...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
- 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
$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...RiskContract work- 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
- ...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 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
- 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
$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...RiskContract workWork at officeImmediate startNight shift- 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...RiskWork at office
- ...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...RiskContract workWork at officeRemote workWork from home
- 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...RiskContract workWork at officeLocal area3 days per week
$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...RiskLocal areaVisa sponsorship- ...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...RiskHourly payPart timeFor contractorsRemote work
$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...RiskWorldwideFlexible hours- ...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
$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...RiskWork at officeRemote workMonday to Friday$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...RiskFull timeContract workWork experience placementSummer workRemote workFlexible hours2 days per week$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...RiskFull timeTemporary workWork at officeLocal areaFlexible hoursShift work2 days per week
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