Talent.com
serp_jobs.error_messages.no_longer_accepting
Executive Director / VP Quality and Regulatory

Executive Director / VP Quality and Regulatory

GTS ScientificPrinceton, NJ, US
job_description.job_card.variable_days_ago
serp_jobs.job_preview.job_type
  • serp_jobs.job_card.full_time
job_description.job_card.job_description

Job Description

Executive Director / VP Quality and Regulatory

Location : On-site (with flexibility for hybrid work)

Travel : ~15–20% domestic / international

Position Summary

A growing, global contract services provider in the pharmaceutical industry is seeking an accomplished Executive Director / VP Quality and Regulatory. This executive leader will oversee the Quality Assurance, Quality Control, and Regulatory Affairs functions for a dynamic organization focused on commercial drug manufacturing and clinical trial supply chain services.

The role requires deep expertise in global regulatory compliance (FDA, EMA, etc.), strong leadership in quality systems, and experience navigating both commercial and clinical operations within a regulated GxP environment.

Strategic Leadership

  • Define and execute the Quality and Regulatory strategy in alignment with enterprise growth goals.
  • Participate in senior leadership forums to guide overall business direction and risk management.
  • Serve as the primary Quality and Regulatory representative in client, regulatory, and external stakeholder engagements.

Quality Assurance & Systems

  • Lead quality oversight across manufacturing, packaging, labeling, and distribution.
  • Ensure compliance with cGMP (21 CFR Parts 210 / 211), EU GMPs, and ICH standards.
  • Maintain audit readiness and drive continuous improvement across all quality operations.
  • Track and enhance quality performance metrics (e.g., deviations, CAPAs, complaint trends).

    • Regulatory Affairs

  • Develop and manage regulatory compliance strategies across all product lifecycle stages.
  • Interpret and implement evolving global regulatory requirements.
  • Direct preparation of regulatory filings including site registrations and amendments.
  • Act as a liaison with regulatory agencies and client representatives.

    • Clinical Supply Chain Compliance

  • Ensure compliance with GCP, GMP, and GDP in clinical packaging, labeling, and distribution.
  • Oversee qualification of depots, shipping lanes, and cold chain systems.
  • Maintain controls over investigational product handling, reconciliation, and destruction.

    • Leadership & Talent Development

  • Lead and develop a high-performing, technically strong Quality & Regulatory team.
  • Ensure team resourcing, capability building, and training keep pace with company growth.
  • Promote cross-functional collaboration with operations, supply chain, and commercial teams.

    • Qualifications

    Education

  • Bachelor’s degree in a scientific or technical field required (Pharmacy, Chemistry, Biology, Engineering, etc.)
  • Advanced degree (MS, PharmD, PhD, MBA) preferred.

    • Experience

  • 15+ years of progressive leadership in pharmaceutical quality and regulatory functions.
  • Minimum 5 years in an executive / senior leadership role.
  • Experience in a contract development and manufacturing or clinical supply environment is strongly preferred.
  • Demonstrated success managing global regulatory inspections and audits.
  • Familiarity with sterile, oral solid dose, or biologic drug manufacturing is a plus.

    • Core Competencies

  • Expert knowledge of cGMP, GDP, GCP, ICH, and global regulatory expectations.
  • Strategic and operational leadership with executive presence.
  • Strong decision-making, analytical thinking, and communication skills.
  • Proven ability to thrive in a fast-paced, client-driven organization.
    • serp_jobs.job_alerts.create_a_job

    Executive Regulatory • Princeton, NJ, US

    Job_description.internal_linking.related_jobs
    • serp_jobs.job_card.promoted
    Director, Enterprise Functional Excellence

    Director, Enterprise Functional Excellence

    Novartis Group CompaniesEast Hanover, NJ, United States
    serp_jobs.job_card.full_time
    The Insights and Decision Science (IDS) team is dedicated to enabling improved decision making at Novartis by leveraging superior data to identify actionable insights that drive enhanced performanc...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Executive Director Drug Safety and Pharmacovigilance

    Executive Director Drug Safety and Pharmacovigilance

    Acadia PharmaceuticalsPrinceton, NJ, US
    serp_jobs.job_card.full_time
    In this role, this individual will be responsible for overseeing all aspects of product safety across clinical development and post-marketing surveillance. They will support the overall strategy and...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Director, Global Medical and Promotional Regulatory Affairs

    Director, Global Medical and Promotional Regulatory Affairs

    Jazz PharmaceuticalsPhiladelphia, PA, United States
    serp_jobs.job_card.full_time
    If you are a current Jazz employee please apply via the Internal Career site.Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Chief of Oncologic Quality

    Chief of Oncologic Quality

    RWJBarnabas HealthLivingston, US
    serp_jobs.job_card.full_time
    RWJBarnabas Health is seeking an experienced and dedicated.This physician leader will oversee, plan, and execute strategies to elevate patient outcomes, safety, and satisfaction while meeting natio...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    • serp_jobs.job_card.new
    Director, Global Customs & Trade Compliance

    Director, Global Customs & Trade Compliance

    Bristol-Myers SquibbPiscataway, NJ, US
    serp_jobs.job_card.full_time +1
    Those aren't words that are usually associated with a job.But working at Bristol Myers Squibb is anything but usual.Here, uniquely interesting work happens every day, in every department.From optim...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_hours
    • serp_jobs.job_card.promoted
    Vice President Surety

    Vice President Surety

    Diedre Moire Corp.Philadelphia, PA, US
    serp_jobs.job_card.full_time
    VP Surety Risk Underwriting - Philadelphia, PA VP Vice President Executive Director Program Manager Product Manager Underwriter Underwriting Manager Team Leader Commercial Contract Surety _.Shall b...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Executive Director, Venture Lab

    Executive Director, Venture Lab

    Wharton SchoolPhiladelphia, PA, US
    serp_jobs.job_card.full_time
    Executive Director, Venture Lab.The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation.This historic, Ivy Le...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Executive Director, Portfolio & Pipeline Strategy

    Executive Director, Portfolio & Pipeline Strategy

    Novartis Group CompaniesEast Hanover, NJ, United States
    serp_jobs.job_card.full_time
    This position will be based in East Hanover, NJ and will not have the ability to be located remotely.Please note that this role would not provide relocation, and only local candidates will be consi...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Associate Director, Content Process Effectiveness

    Associate Director, Content Process Effectiveness

    Novartis Group CompaniesEast Hanover, NJ, United States
    serp_jobs.job_card.full_time
    Join Novartis as the Associate Director, Content Process Effectiveness, and play a pivotal role in optimizing the content supply chain and leading operational reporting platforms to support US busi...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Sr. Director, Site Quality Head

    Sr. Director, Site Quality Head

    Minaris Advanced TherapiesPhiladelphia, PA, US
    serp_jobs.job_card.full_time
    Be part of something bigger at Minaris Advanced Therapies—where every role contributes to creating hope for patients around the world. As a global leader in cell and gene therapy development, ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Executive Director, Regulatory CMC Small Molecule New Products

    Executive Director, Regulatory CMC Small Molecule New Products

    MerckRahway, NJ, US
    serp_jobs.job_card.full_time
    Executive Director, Chemistry, Manufacturing & Controls (Cmc) Pre-Approval Pharm.Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity, and teamwork of an individu...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Quality Director

    Quality Director

    Gilbane Building CompanyPhiladelphia, PA, United States
    serp_jobs.job_card.full_time
    US-RI-Providence | US-VA-Arlington | US-NC-Charlotte | US-GA-Atlanta | US-IL-Chicago | US-MA-Boston | US-PA-Philadelphia. Quality Assurance / Quality Control.This role ensures that construction prac...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Director, Clinical Quality Assurance

    Director, Clinical Quality Assurance

    EisaiPhiladelphia, PA, United States
    serp_jobs.job_card.full_time
    At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission.We're a growing pharm...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Director, Regulatory Affairs Advertising & Promotion

    Director, Regulatory Affairs Advertising & Promotion

    Novartis Group CompaniesEast Hanover, NJ, United States
    serp_jobs.job_card.full_time
    Novartis has an incredible opportunity for a talented individual to join our team as the Director, Regulatory Affairs Advertising & Promotion. You will provide strategic regulatory advice on.US orga...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Executive Director, Integrated Trial Process, PRS

    Executive Director, Integrated Trial Process, PRS

    Novartis Group CompaniesEast Hanover, NJ, United States
    serp_jobs.job_card.full_time
    We work collaboratively to integrate cross-functional expertise into streamlined, end-to-end trial processes underpinned by innovation and risk-based quality management, so Novartis can deliver hig...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Executive Director - Decision Science, Product Lead - Immunology

    Executive Director - Decision Science, Product Lead - Immunology

    Novartis Group CompaniesEast Hanover, NJ, United States
    serp_jobs.job_card.full_time
    The ideal location for this role is East Hanover, NJ but a distant working arrangement may be possible in certain states. Distant workers are responsible.East Hanover, NJ, as determined necessary by...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Chief of Oncologic Quality

    Chief of Oncologic Quality

    HealthEcareers - ClientLivingston, NJ, USA
    serp_jobs.job_card.full_time
    RWJBarnabas Health is seeking an experienced and dedicated.This physician leader will oversee, plan, and execute strategies to elevate patient outcomes, safety, and satisfaction while meeting natio...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Director / Senior Director Biostatistics

    Director / Senior Director Biostatistics

    Novartis Group CompaniesEast Hanover, NJ, United States
    serp_jobs.job_card.full_time
    As the Director / Sr Biostatistics, you will influence and drive statistical strategy / innovation directly taking part in cross-functional collaboration and decision making for program(s) across multi...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Regulatory Specialist

    Regulatory Specialist

    ChubbPhiladelphia, PA, US
    serp_jobs.job_card.full_time
    Chubb’s activities in the United States, and .This role can sit in our Philadelphia, PA or New York, NY offices.Major Duties and Responsibilities : . Assist in the planning and coordination of adminis...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_1_day
    • serp_jobs.job_card.promoted
    Executive Director, Functional AI and Process - General Management

    Executive Director, Functional AI and Process - General Management

    Novartis Group CompaniesEast Hanover, NJ, United States
    serp_jobs.job_card.full_time
    The ideal location for this role is East Hanover, NJ.The Executive Director of Functional AI and Process Excellence, works with a team of other EDs of Functional AI and Process Excellence leads acr...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days