Senior Compliance and Regulatory Expert

4 weeks ago

Reston, Virginia, United States Planet Pharma Full time

The Senior Regulatory and Compliance Specialist candidate must possess in-depth knowledge of global regulations pertinent to the pharmaceutical industry and their impact on manufacturing processes and practices. The ideal candidate must be agile, with well-developed organizational, interpersonal, compliance, and practical application skills. This individual must be a self-starter, results-oriented, with the ability to receive, compile, analyze, disseminate, and articulate data and its implications at both site and broader program levels. This role has high visibility within the Somerset site and the greater organization as it touches various functional areas including: Supplier Quality, Regulatory Compliance, DEA, and QMS.

This role is part of the Clinical Development and Supply division, which is part of the broader Pharmaceutical and Consumer Health Segment within the business structure. This role is based out of the Somerset, NJ site.

Key Responsibilities:

  • Manage the supplier quality program and ensure Supplier Quality Management deliverables are met as required.
  • Facilitate and host customer audits at the Somerset site to ensure compliance with cGMPs, as well as Corporate and site standard operating procedures.
  • Facilitate and participate in corporate internal audits to ensure compliance with FDA and applicable international health authority regulations.
  • Lead the activities for preparing an oral solid dose manufacturing site for inspections by US FDA and applicable foreign regulatory authorities. Participate in all aspects of inspections from initiation, preparation, execution through closure.
  • Lead the internal audit program at the site.
  • Assist the site in preparing written responses to address the observations for customer audits, internal audits, corporate audits, and regulatory inspections. Ensure responses are completed as committed.
  • Inform QA management where resolution of audit findings is inadequate or when audit commitments are not met.
  • Initiate deviations when site procedures are not followed.
  • Assist in preparing for PAI audits for new product approvals at site, compiling documents and reviewing to ensuring audit readiness.
  • Participate in the preparation of Supplier and Customer Quality Agreements.
  • Participate in global supplier and regulatory meetings and effectively represent the site.
  • Review and approve TrackWise Records as needed acting as a QA Representative.
  • Review and revise departmental SOPs as required.
  • Comply with Environmental, Health & Safety requirements.
  • Other ad hoc duties as assigned.

Requirements:

  • A bachelors degree with at least 5+ years of experience working in the pharmaceutical industry in Quality/Regulatory Compliance, Quality Assurance, Quality Management Systems or associated pharmaceutical manufacturing related function
  • Associate degree or High School Diploma with 10+ years of experience working in the pharmaceutical industry in Quality/Regulatory Compliance, Quality Assurance, Quality Management Systems or associated pharmaceutical manufacturing related function

Knowledge and Skills:

  • Knowledge of US FDA regulatory requirements as it pertains to solid oral dosage forms or prior experience working in a regulated field is required.
  • Deep understanding of FDA and cGMP regulations pertaining to clinical and commercial pharmaceutical drug manufacturing activities is required.
  • Understanding of various audit types (e.g. Customer, Supplier, Agency etc.) and techniques (e.g. Onsite, Questionnaire etc.) is preferred
  • TrackWise experience is preferred.
  • ASQ CQA or relevant Certification is highly preferred

  • Chief Compliance Officer

    1 month ago

    Reston, Virginia, United States Blue Chip Partners Full time

    Job Title: Chief Compliance OfficerWe are seeking an experienced Chief Compliance Officer to lead and manage all aspects of our compliance program. This position reports directly to our executives and has no direct reports.Key Responsibilities:Implement and maintain our compliance program to ensure compliance with the Investment Advisers Act of 1940 and...

  • Compliance Officer

    4 weeks ago

    Reston, Virginia, United States Financial Staffing LLC Full time

    Compliance Officer Role SummaryFinancial Institutions ComplianceJob Responsibilities:Ensure bank policies, procedures, and systems comply with federal and state banking laws and regulations.Monitor new and revised legislation; work with management to determine impacts; and assist in the implementation and training associated with the new and revised...

  • Regulatory Compliance Specialist

    1 month ago

    Reston, Virginia, United States Rare Beauty Full time

    About the RoleRare Beauty is seeking a highly skilled Regulatory Specialist to join our Research and Development team. As a key member of our team, you will be responsible for ensuring the safety and regulatory compliance of our products, while also collaborating with internal teams and external partners to drive product development and innovation.Key...

  • Senior Compliance Manager

    3 weeks ago

    Reston, Virginia, United States Larson Maddox Full time

    Larson Maddox is seeking an experienced Senior Compliance Manager to lead the oversight of client services operations and onboarding for the firm's institutional clientele. This role requires strong expertise in institutional investing and prior experience in a compliance and client operations role.The ideal candidate will have leadership experience in...

  • Regulatory Compliance Specialist

    4 weeks ago

    Reston, Virginia, United States Rare Beauty Full time

    About Rare BeautyRare Beauty is a company that aims to break down unrealistic standards of perfection. We empower our team and community to challenge beauty norms by shaping positive conversations about self-acceptance and mental health. Our mission is to help everyone celebrate their individuality by redefining what beautiful means.Job SummaryThe Regulatory...

  • Senior Investment Funds Regulatory Specialist

    3 weeks ago

    Reston, Virginia, United States Sonder Consultants Full time

    The ideal candidate for this senior investment funds regulatory associate role will have a strong background in regulatory funds and a deep understanding of the US market.With at least 3 years' experience in regulatory funds at a leading firm in the US, the successful candidate will have strong academics and be qualified to practice in the relevant state.The...

  • Regulatory Compliance Specialist

    2 months ago

    Reston, Virginia, United States EVONA Full time

    Regulatory EngineerAt EVONA, we are seeking a highly skilled Regulatory Engineer to support our client's spectrum coordination efforts with federal and international entities. As a key member of our team, you will represent the company in ITU study groups, Regional Telecommunications Organizations, and other regulatory bodies, driving strategies to secure...

  • Cyber Security Advisor

    1 month ago

    Reston, Virginia, United States Eccalon, LLC Full time

    Eccalon, LLC is seeking a highly skilled Cyber Security Advisor to lead and manage the client organization's efforts to achieve and maintain CMMC certification. This role requires an in-depth understanding of the CMMC framework, including its requirements, processes, and implementation strategies.The ideal candidate will have a strong technical background in...

  • Regulatory Compliance Coordinator

    3 weeks ago

    Reston, Virginia, United States Northwest Asset Management Full time

    Job SummaryThe Compliance Specialist plays a critical role in managing registration and regulatory compliance processes for SEC and state-registered firms. This position involves overseeing RIA registration processing, customizing Form ADV Parts 2A and 2B, and ensuring timely submission of annual renewal fees. This multifaceted role is essential for ensuring...

  • Senior Solutions Consultant

    1 month ago

    Reston, Virginia, United States The Ash Group Full time

    Our Client from the Government Administration space is actively searching for a Senior Solutions Consultant - Technology Expert. Please take a look at the notes below.Setting: Remote in Colorado - opportunity to come into office if desiredDuration: 13-month contractThe Ash Group is seeking an experienced Senior Solutions Consultant to provide strategic...

  • Regulatory Project Manager Senior Specialist

    4 weeks ago

    Reston, Virginia, United States ACE Partners Full time

    We are seeking a Senior Specialist, Regulatory Project Management to lead key initiatives across a global portfolio of medical devices and combination products.This hybrid role is based in Exton, PA, and is ideal for candidates within a 50-mile radius or those open to relocating.About the Role:As a Senior Specialist, you will be at the forefront of...

  • Regulatory Compliance Specialist

    3 weeks ago

    Reston, Virginia, United States I3 INFOTEK INC Full time

    Job Summary:The Quality Assurance Specialist will play a vital role in ensuring the compliance of manufacturing operations with regulatory and industry standards. This position involves on-floor oversight to guarantee that processes adhere to quality standards.Main Responsibilities:• Conduct real-time documentation reviews of batch records, cleaning logs,...

  • Senior Quality Assurance Compliance Specialist

    4 weeks ago

    Reston, Virginia, United States Metric Bio Full time

    Metric Bio is seeking a Senior Quality Assurance Compliance Specialist to join their team in Wisconsin, specializing in GMP intermediates, APIs, and excipients.This permanent role offers a competitive compensation package and an innovative work environment.Role Overview: The Senior QA Compliance Specialist ensures adherence to cGMP compliance and regulatory...

  • Senior QA Lead

    4 weeks ago

    Reston, Virginia, United States Cigniti Technologies Full time

    About Cigniti Technologies: We're a leading force in the quality engineering space, shaping the future of innovation in quality engineering and defining it. If you're ready to elevate your career and make a significant impact on global enterprises, this is your opportunity.About the Role: We're seeking a highly skilled and experienced Senior QA Lead with...

  • Senior Compliance Manager

    4 weeks ago

    Reston, Virginia, United States Larson Maddox Full time

    A top Global Investment Management firm in Los Angeles is seeking a Senior Compliance Manager to oversee client services operations and onboarding for institutional clients, providing compliance support on investment offerings across multiple business lines, while managing a small team of direct reports.This role will be primarily responsible for overseeing...

  • Regulatory Affairs Specialist

    3 weeks ago

    Reston, Virginia, United States GForce Life Sciences Full time

    Job Title: Regulatory Affairs SpecialistJob Summary: We are seeking a highly skilled Regulatory Affairs Specialist to join our team at GForce Life Sciences. The ideal candidate will have a strong background in regulatory compliance and quality systems.Key Responsibilities:Implement and maintain quality systems to ensure compliance with regulatory...

  • Senior Financial Planning Expert

    4 weeks ago

    Reston, Virginia, United States Baystate Financial Full time

    Company OverviewBaystate Financial is a leading financial services firm with a rich history dating back to 1901. Headquartered in Boston, MA, we have 16 office locations throughout New England, providing a wide range of financial solutions to our clients.Role SummaryThis is a full-time hybrid role for a Senior Financial Advisor at our Bedford, NH location....

  • Regulatory Affairs Director

    4 weeks ago

    Reston, Virginia, United States HireNetworks Full time

    The Director of Regulatory Affairs will play a key role in providing technical and managerial leadership to resources through both direct and indirect reporting structures. This role will be responsible for leading regulatory service projects by providing robust regulatory strategies, leading interactions with regulatory agencies, and preparing regulatory...

  • Compliance Lead

    3 weeks ago

    Reston, Virginia, United States Plannery Full time

    About Plannery:We're transforming personal finance for 18M U.S. healthcare professionals by automating debt repayment, expense management, and wealth-building. Our leadership team brings deep expertise in scaling startups—our CEO has led ventures acquired by SoFi and FedEx, and our CTO raised $125M from top VCs at his previous company. Backed by investors...

  • Senior Technical Expert

    4 weeks ago

    Reston, Virginia, United States Black Bear Technology Solutions, LLC Full time

    Job Title: Senior Subject Matter Expert III Location: Fairfax, VA Clearance: Minimum of a Secret Clearance is required Provides expert advice and insight concerning strategic direction and applicability of up to date, industry standard solutions.Responsible for providing high level vision to program/project manager and/or senior client leadership to...