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Compliance specialist Jobs in Lynn, MA

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Compliance specialist • lynn ma

Last updated: 3 days ago
USA - Quality Compliance Specialist

USA - Quality Compliance Specialist

ApolisCambridge, MA, United States
Full-time
Actual Job Title - Clinical Quality Compliance Lead.Hybrid - Must be local to Boston, MA.Provides quality oversight to the clinical trial delivery quality systems, promoting operational and complia...Show moreLast updated: 5 days ago
  • Promoted
USA - Quality Compliance Specialist

USA - Quality Compliance Specialist

StaffingCambridge, MA, US
Full-time
Clinical Quality Compliance Lead Hybrid.Objectives / Purpose : Provides quality oversight to the clinical trial delivery quality systems, promoting operational and compliance excellence, quality risk ...Show moreLast updated: 30+ days ago
Compliance and Contracts Specialist - Healthcare

Compliance and Contracts Specialist - Healthcare

Boston Health Care for the Homeless ProgramBoston, MA, US
Full-time +1
Since 1985, BHCHP’s mission has been to ensure unconditionally equitable and dignified access to the highest quality health care for all individuals and families experiencing homelessness in ...Show moreLast updated: 12 days ago
Environmental Compliance Specialist

Environmental Compliance Specialist

Mabbett & AssociatesStoneham, MA
Full-time
Mabbett), an award-winning leader in environmental, health, and safety consulting and engineering services, is seeking a full-time Environmental Compliance Specialist. This role involves supporting ...Show moreLast updated: 30+ days ago
USA - Quality Compliance Specialist | 60% Remote

USA - Quality Compliance Specialist | 60% Remote

Alpha Business SolutionsCambridge, MA, United States
Remote
Full-time
Clinical Quality Compliance Lead.Hourly Rate : This is an hourly contract position with potential to extend, rate variues based on experience from $100 / HR to $130 / HR. Hybrid - Must be local to Boston...Show moreLast updated: 5 days ago
  • Promoted
Environmental Compliance Specialist

Environmental Compliance Specialist

Mabbett AssociatesStoneham, Massachusetts, USA
Full-time
Mabbett) an award-winning leader in environmental health and safety consulting and engineering services is seeking a full-time Environmental Compliance Specialist. This role involves supporting vari...Show moreLast updated: 18 days ago
Compliance Specialist

Compliance Specialist

Katalyst HealthCares & Life SciencesBoston, MA
Full-time
We are seeking an experienced Compliance Specialist to support enterprise-scale vulnerability remediation, OS upgrade projects, and infrastructure compliance across lab and manufacturing environmen...Show moreLast updated: 30+ days ago
  • Promoted
Global Trade Compliance Specialist

Global Trade Compliance Specialist

Axcelis TechnologiesBeverly, MA, US
Full-time
Global Trade Compliance Specialist.Want to discover just how far your intellectual curiosity can take you? You're in the right place. For more than four decades, Axcelis Technologies has been at the...Show moreLast updated: 30+ days ago
  • Promoted
Regulatory Compliance Specialist 3

Regulatory Compliance Specialist 3

Boston StaffingBoston, MA, US
Full-time
Regulatory Compliance Specialist.Assists and supports the organization in complying with, as well as the ongoing preparation, testing, and monitoring of conformance to, the requirements of governme...Show moreLast updated: 29 days ago
Senior Compliance Specialist

Senior Compliance Specialist

Sentinel GroupWakefield, MA, US
Full-time
This a hybrid role for our Wakefield, MA office.Do you want to work for a fun, growing organization where people truly make a difference? . We are seeking a knowledgeable and proactive Senior C...Show moreLast updated: 30+ days ago
Tax & Compliance Research Specialist

Tax & Compliance Research Specialist

Catalyst LabsBoston, MA, US
Full-time
Catalyst Labs is a leading talent agency specializing in Tax, Tax Technology and Transfer Pricing.We stand out as an agency that is deeply embedded in our clients recruitment operations.Partners an...Show moreLast updated: 3 days ago
  • Promoted
Compliance Corrections Specialist

Compliance Corrections Specialist

CenteneBoston, MA, US
Full-time +1
Compliance Oversight Specialist.You could be the one who changes everything for our 28 million members.Centene is transforming the health of our communities, one person at a time.As a diversified, ...Show moreLast updated: 30+ days ago
  • Promoted
Environmental Compliance Specialist

Environmental Compliance Specialist

Mabbett & Associates, Inc.Stoneham, Massachusetts, United States
Full-time
Mabbett®), an award-winning leader in environmental, health, and safety consulting and engineering services, is seeking a full-time Environmental Compliance Specialist. This role involves supporting...Show moreLast updated: 5 days ago
  • Promoted
Compliance Specialist

Compliance Specialist

Katalyst Healthcares & Life SciencesBoston, MA, US
Full-time
We are seeking an experienced Compliance Specialist to support enterprise-scale vulnerability remediation, OS upgrade projects, and infrastructure compliance across lab and manufacturing environmen...Show moreLast updated: 30+ days ago
  • Promoted
Prin Compliance Specialist

Prin Compliance Specialist

Constellation EnergyEverett, MA, US
Full-time
Serve as one of the companys primary points of contact with the Federal Energy Regulatory Commission (FERC) and the Pipeline & Hazardous Materials Safety Administration (PHMSA) the Commissioners, ...Show moreLast updated: 30+ days ago
Operational Compliance Specialist

Operational Compliance Specialist

Care AccessBoston, MA, US
Full-time
Care Access is working to make the future of health better for all.With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health ser...Show moreLast updated: 30+ days ago
  • Promoted
Advertising Compliance Specialist (Hybrid)

Advertising Compliance Specialist (Hybrid)

American Family InsuranceBoston, MA, United States
Full-time
As an Advertising Compliance Specialist, you will provides a full range of compliance oversight, advice and services with specialist knowledge in support of the business. You will focus on ensuring ...Show moreLast updated: 30+ days ago
USA - Quality Compliance Specialist

USA - Quality Compliance Specialist

MindlanceCambridge, MA, United States
Full-time
Actual Job Title - Clinical Quality Compliance Lead.Hybrid - Must be local to Boston.Provides quality oversight to the clinical trial delivery quality systems, promoting operational and compliance ...Show moreLast updated: 5 days ago
Senior Compliance Specialist

Senior Compliance Specialist

Maloney Properties, IncGreater Boston Area
Full-time
Maloney Properties – Voted “Best Place to Work” by our employees for 10 years!.Join our hard-working motivated team! Our reputation for customer service and quality workmanship is the best in the i...Show moreLast updated: 30+ days ago
People also ask
USA - Quality Compliance Specialist

USA - Quality Compliance Specialist

ApolisCambridge, MA, United States
5 days ago
Job type
  • Full-time
Job description

Actual Job Title - Clinical Quality Compliance Lead

Hybrid - Must be local to Boston, MA

Pay Rate : $135 / Hour on W2

OBJECTIVES / PURPOSE :

  • Provides quality oversight to the clinical trial delivery quality systems, promoting operational and compliance excellence, quality risk management and knowledge management.
  • Maintains a state of control by implementing effective monitoring and control systems that ensures the quality systems supporting the clinical trial delivery is robust and aligned with ap-plicable regulations.
  • Partners with the different functions that contribute to the clinical trial delivery in identifying systemic quality and compliance risks, conducting robust investigations and developing ade-quate corrective and preventive actions (CAPAs), managing changes and facilitating continual improvement that is aligned to
  • 's values and strategic priorities.
  • Reports to and acts as a strategic thought partner to the Head of GCP Quality Compliance in developing and implementing GCP Compliance strategies, in managing the operational activi-ties of and building capabilities within the GCP Compliance function and in ensuring alignment with the CPMQ vision.

ACCOUNTABILITIES :

  • Leads the clinical trial delivery system inspection readiness program, including the development and implementation of a strategic plan. Engages with relevant functions and stakeholders to ensure inspection readiness, driving accountability and transparency. Functions include, but not limited to, Global Development Office, Data Science Institute, Global Regulatory Affairs, Procurement, Legal, etc.
  • Provides insights to emerging regulations and requirements, operational and compliance met-rics and storyboards, identifies quality and compliance inspection risks, and proactively pro-vides strategic and tactical directions in the mitigation.
  • Hosts GCP inspections, and provides strategic direction to relevant functions and Subject Mat-ter Experts (SME).
  • Ensures a robust communication plan is in place, that enables knowledge sharing of insights and risks. Communicates the progress of inspections on a daily basis, summarizing succinctly the inspection activities and potential observations and mitigation activities. Effectively and timely escalates to management.
  • Leads and manages the inspection response activities, ensuring the responses are adequate, reviewed and approved internally by the relevant stakeholders, at the right levels and submit-ted on time. Reviews and provides input to response to ensure the impact is thoroughly as-sessed, appropriate root cause is identified, and specific, measurable, achievable, relevant and time-bound CAPAs are developed.
  • Oversees the completion and closure of inspection CAPAs, ensuring that no inspection CAPAs are late. Mitigates and escalates any risks. Ensures appropriate effectiveness checks are developed for relevant inspection CAPAs. Provides input to the effectiveness check plans, and reviews and approves outcome.
  • Acts as Subject Matter Expert (SME) on the Clinical Quality Compliance activities including de-viation management, quality investigation, corrective and preventive actions (CAPA) manage-ment and oversight and change control. Represent Clinical Quality Compliance in these topics in inspections.
  • Support and provide relevant guidance to other other non-GCP specific inspections (e.g., GVP, GMP, etc).
  • Leads complex quality investigations impacting the clinical trial delivery systems. Provide Quali-ty Leadership for other quality investigations ensuring the right stakeholders are engaged in impact assessment, root cause analysis and CAPA development.
  • Develop lessons learned from on regulatory inspections, and quality investigations. Promotes knowledge management.
  • Leads cross-functional continual improvements projects that enable a compliant quality sys-tems in the clinical trial delivery quality systems.
  • Review and approve controlled procedures related to clinical trial delivery quality systems to ensure regulatory and past inspection commitments are considered.
  • Escalates issues of potentially critical non-compliance and / or lack of urgency in remediation to senior management. Analyzes results, quality issues and investigation to identify actionable trends and to promote a state of compliance.
  • Develops and monitors relevant metrics and Key Performance / Quality Indicators (KPI / KQI). Mitigates, communicates, and escalates any risks flagged by the metrics and KPIs / KQIs, ensur-ing actions are commensurate to the risk and timely. Drives the development and executes the strategy to understand the health of the clinical trial delivery quality system (i.e. risk register, KPIs).
  • Contributes to any relevant quality and compliance governance in
  • , including the and the Clinical & Safety Quality Council, communicating any quality or compliance risks and op-portunities, continual improvements and successes.
  • EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS :

  • BSc in a scientific or allied health / medical field (or equivalent degree).
  • Minimum of 7 years of increasing responsibility and relevant experience in the global pharma-ceutical industry in functions such as Clinical Operations, Data Management and Statistics, with at least 3 years of experience in GCP Quality / Compliance.
  • Advanced knowledge of pharmaceutical development, medical affairs and GCP / GVP regula-tions including FDA, EU, MHRA, PMDA and ICH.
  • Experience must include successful development and implementation of a clinical or pharma-covigilance audit program, hosting / leading regulatory inspections and remediation activities on a global level.
  • Experience in managing complex organizational compliance issues and in identifying and im-plementing organization-wide compliance initiatives.
  • Skilled in managing global, cross-functional projects.
  • Fluency in written and spoken English, additional language skills a plus.