Senior Regulatory Compliance Specialist

3 days ago


Somerset, New Jersey, United States Adecco US, Inc. Full time
Senior Regulatory and Compliance Specialist Job Description

Adecco US, Inc. is seeking a highly motivated and experienced Senior Regulatory and Compliance Specialist to join our client's team in Somerset, NJ.

Key Responsibilities:
  • Manage supplier quality program and ensure compliance with Supplier Quality Management deliverables.
  • Conduct and host customer and internal audits to ensure compliance with cGMPs, corporate, and site standard operating procedures.
  • Lead inspection preparation activities for US FDA and foreign regulatory authorities.
  • Lead the internal audit program at the site.
  • Prepare and submit written responses to audit findings and regulatory observations.
  • Initiate deviations when necessary and participate in PAI audits.
  • Participate in supplier and customer quality agreements, as well as global meetings.
  • Review and approve TrackWise records and revise departmental SOPs as needed.
  • Adhere to environmental, health, and safety requirements.
Requirements:
  • Bachelor's degree with 5+ years of experience in the pharmaceutical industry in Quality/Regulatory Compliance, Quality Assurance, Quality Management Systems, or related manufacturing function.
  • Deep understanding of FDA and cGMP regulations pertaining to clinical and commercial pharmaceutical drug manufacturing activities.
  • Knowledge of US FDA regulatory requirements for solid oral dosage forms preferred.
  • Experience with audit types and techniques.
  • TrackWise experience preferred.
  • ASQ CQA or relevant certification highly preferred.
Benefits:
  • $53.00 per hour
  • Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits, and a 401K plan.
  • Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs.

Adecco US, Inc. is an Equal Opportunity Employer/Veterans/Disabled. To read our Candidate Privacy Information Statement, please navigate to https://www.adeccousa.com/candidate-privacy-information-statement.



  • Somerset, New Jersey, United States Adecco Full time

    Senior Regulatory and Compliance Specialist Job DescriptionAdecco is seeking a skilled Senior Regulatory and Compliance Specialist to support global regulatory compliance within the pharmaceutical industry. The ideal candidate will be experienced in pharmaceutical regulations, compliance practices, and their impact on manufacturing.This role offers high...


  • Somerset, New Jersey, United States Planet Pharma Full time

    Job Title: Senior Compliance and Regulatory SpecialistPlanet Pharma is seeking a highly skilled Senior Compliance and Regulatory Specialist to join our team. As a key member of our Clinical Development and Supply division, you will play a critical role in ensuring compliance with global regulations and industry standards.Key Responsibilities:Manage the...


  • Somerset, New Jersey, United States Intellectt Inc Full time

    {"title": "Regulatory Compliance Specialist", "description": "Job SummaryWe are seeking a highly skilled Regulatory Compliance Specialist to join our team at Intellectt Inc. in Somerset, NJ.The ideal candidate will have a deep understanding of global regulations pertaining to the pharmaceutical industry and their impact on manufacturing processes and...


  • Somerset, New Jersey, United States Terumo Medical Corporation Full time

    Position Overview:The Healthcare Compliance Specialist plays a crucial role in assisting the Director of Healthcare Compliance with various departmental projects aimed at fostering the development and execution of the Company Ethics and Compliance Program within the designated Terumo division(s).Key Responsibilities:1. Collaborate with the Director to...


  • Somerset, New Jersey, United States Terumo Medical Corporation Full time

    Job Summary:The Healthcare Compliance Manager supports the Director of Healthcare Compliance in driving departmental initiatives to develop and implement the Company's Ethics and Compliance Program across assigned Terumo Medical Corporation divisions.Key Responsibilities:Collaborate with the Director of Healthcare Compliance to develop and implement the...


  • Somerset, New Jersey, United States Terumo Medical Corporation Full time

    Job Summary:The Healthcare Compliance Manager supports the Director of Healthcare Compliance in driving departmental initiatives to develop and implement the Company's Ethics and Compliance Program across assigned Terumo Medical Corporation divisions.Key Responsibilities:Collaborate with the Director of Healthcare Compliance to develop and implement the...


  • Somerset, New Jersey, United States Terumo Medical Corporation Full time

    Position Overview:The Healthcare Compliance Manager plays a pivotal role in assisting the Director of Healthcare Compliance with various departmental projects aimed at fostering the development and execution of the Company Ethics and Compliance Program within the designated Terumo division(s).Key Responsibilities:1. Collaborate with the Director to enhance...


  • Somerset, New Jersey, United States Terumo Medical Corporation Full time

    Position Overview:The Healthcare Compliance Manager plays a crucial role in assisting the Director of Healthcare Compliance with various departmental projects aimed at enhancing and executing the Company's Ethics and Compliance Program within the designated Terumo division(s).Key Responsibilities:- Collaborate with the Director to develop compliance...


  • Somerset, New Jersey, United States Paragon Staffing Full time

    Job SummaryParagon Staffing, LLC is a leading staffing agency that specializes in connecting job seekers with top employers who are seeking temporary, contract, or permanent positions.Due to our continued growth, we are seeking a highly skilled Health and Safety Compliance Officer to join our team!Key ResponsibilitiesEnsure that all health and safety...

  • Senior Tax Accountant

    4 weeks ago


    Somerset, New Jersey, United States Vaco Full time

    Job SummaryVaco is seeking a highly skilled Senior Indirect Tax Accountant to join our team. As a key member of our tax department, you will be responsible for researching and analyzing tax issues and implications for both the US and Canada.Key ResponsibilitiesResearch and Analysis: Conduct in-depth research on tax laws and regulations in relevant state,...


  • Somerset, New Jersey, United States Paragon Staffing Full time

    Job Summary:Paragon Staffing, LLC is a leading staffing agency that specializes in connecting job seekers with top employers who are seeking temporary, contract, or permanent positions.We are seeking a highly skilled Occupational Safety Compliance Specialist to join our team! As a key member of our organization, you will be responsible for ensuring that all...


  • Somerset, New Jersey, United States On-Board Companies Full time

    About the RoleWe are seeking a highly skilled Quality Assurance Specialist to join our team at On-Board Companies. As a key member of our quality team, you will be responsible for ensuring that our manufacturing processes meet the highest standards of quality and regulatory compliance.Key ResponsibilitiesSupport the development and implementation of quality...


  • Somerset, New Jersey, United States LabVantage Full time

    Job SummaryLabVantage is seeking a highly skilled Computer Systems Validation Specialist to join our team. As a key member of our team, you will be responsible for delivering Computer Systems Validation (CSV) services to our clients.Key ResponsibilitiesValidation Consulting Services: Provide advisory services to LabVantage clients on CSV, creation of...


  • Somerset, New Jersey, United States Terumo Medical Corporation Full time

    Job SummaryThe Director of Quality Systems and Compliance will be responsible for the design, development, deployment, and maintenance of the company's Quality System. This individual will serve as the primary interface with external regulatory agencies for audits and ensure the Quality System is continually compliant with all applicable regulations and...


  • Somerset, New Jersey, United States Virtual Full time

    Job SummaryVirtual is seeking a highly skilled Senior Tax Professional to join our team. As a key member of our tax department, you will work closely with our Indirect Tax Manager to research and analyze complex tax issues and implications for both the US and Canada.Key ResponsibilitiesCompliance and Reporting: Assist in managing workflow and general...


  • Somerset, New Jersey, United States Vaco Full time

    Job Title: Senior Indirect Tax AccountantVaco Boston is seeking a highly skilled Senior Indirect Tax Accountant to join their team. This individual will work closely with the Indirect Tax Manager to research and analyze tax implications for both the US and Canada, manage workflow, and ensure compliance with sales and use taxes.Key...


  • Somerset, New Jersey, United States Catalent Inc Full time

    Senior Manager, Environmental SustainabilityCatalent is a global leader in the development and manufacturing of new treatments for patients worldwide. As a Senior Manager, Environmental Sustainability, you will play a critical role in driving our company's sustainability strategy and reducing our environmental footprint.Key Responsibilities:Develop and...


  • Somerset, New Jersey, United States On-Board Companies Full time

    About the RoleWe are seeking a highly skilled Quality Assurance Specialist to join our team at On-Board Companies. As a key member of our quality team, you will be responsible for ensuring that our manufacturing processes meet the highest standards of quality and regulatory compliance.Key ResponsibilitiesSupport the development and implementation of quality...


  • Somerset, New Jersey, United States RWJBarnabas Health Full time

    Job Title: Transfer Center SpecialistAt RWJBarnabas Health, we are seeking a highly skilled and detail-oriented Transfer Center Specialist to join our team. As a key member of our healthcare team, you will play a critical role in ensuring the smooth transfer of patients between facilities.Key Responsibilities:Triage and coordinate patient transfers, ensuring...


  • Somerset, New Jersey, United States Paragon Staffing Full time

    Job Title: Occupational Safety Compliance OfficerParagon Staffing, LLC is a leading staffing agency that connects job seekers with top employers. We are seeking a highly skilled Occupational Safety Compliance Officer to join our team.Job Summary:We are looking for a detail-oriented and organized individual to ensure compliance with health and safety...