Associate Director/Director – GCP Audits & GLP Quality Assurance

Duration: 06 Months – 12 Months

The Associate Director/Director – GCP Audits & GLP Quality Assurance will be responsible to lead, manage and coordinate all GCP audits and GLP regulated QA activities. This individual is responsible for independently performing domestic and international audits/inspections that ensure compliance to FDA and other worldwide health authority regulations/guidelines, site SOPs, protocols and industry standards, as applicable. This includes applying developed skills to assure management that the facilities and buildings, equipment, personnel, organization, methods, procedures, records, reports and/or controls are in conformance with applicable regulations. The Associate Director/Director develops and oversees quality policies and audit plans for each nonclinical/clinical study. This individual will play a major role in supporting the global inspection readiness strategy.  S/he will act as an SME in support of audits; internal systems, supplier, and of non-clinical/clinical trial sites.

Essential Duties and Responsibilities include the following:

  • Manages quality assurance activities for all in-house GLP regulated studies and manage GCP Quality audit program for internal systems, Investigational sites, CROs and third-party service providers.
  • Applies skills to assure management that nonclinical studies are conducted in accordance with applicable regulations.
  • Provides recommendations for corrective action and tracks corrective action commitments until closure. Communicate critical compliance risks noted to senior management.
  • Schedule, oversee and/or perform routine and non-routine GCP/GLP audits. Manage CAPA follow up and effectiveness
  • Track GCP/GLP commitments from internal audits, regulatory inspection findings, CAPAs and other regulatory commitments.
  • Serves as the GLP/GCP subject matter expert for the audit staff and client areas.
  • Manages qualification and provides quality oversight of service providers contracted to perform any functions in support of GLP/GCP regulated studies.
  • Plans and conducts GLP audits of GLP regulated service providers to assess compliance with all pertinent regulations as well as company SOPs.
  • Plans and conducts GCP and as applicable GPV regulated service providers to assess compliance with all pertinent regulations as well as company SOPs.
  • Collaborates with Research & Development, non-clinical and Clinical Operations staff to identify, evaluate and recommend solutions to issues identified in the performance of GLP/GCP audits.
  • Conducts audits for service providers contracted to perform any functions in support of GCP, GLP and GPV regulated studies.
  • Manages the internal audit program for GCP and GLP; responsible for scheduling, tracking and metrics.
  • Independently conducts audits and prepares clear and concise written reports of audit observations, including an assessment of compliance. Assesses adequacy of action plan. Conducts follow up activities as needed to monitor corrective actions.
  • Works with other Quality functions to assure alignment and compliance with Quality Management System, supports assessment of compliance and defines metrics to determine performance objectives.
  • Supports the maintenance of the Approved Service Provider list and schedules service provider audits. Ensures that service provider audits are issued in a timely manner as required by SOP(s).
  • Assists with GCP/GLP internal and external training of staff and vendors.
  • Manages internal departmental facility audits if required.
  • Performs special projects as needed.
  • Leads or support GCP inspection readiness, conduct and follow-up activities for clinical programs, Assists during FDA inspections.
  • Collaborates with Clinical Operations, Research and Development/Non-clinical and other relevant departments and Quality to determine acceptability of GCP/GLP Service Providers for potential engagement as well ongoing evaluation of overall compliance performance of Service Providers.
  • Perform other related duties as assigned.

Qualifications:

  • Minimum B.S. degree in science or equivalent.  Advanced degree preferred.
  • Minimum 8-10 years of experience in a regulated environment related to pharmaceutical/biotech industry, with minimum of 7 years of experience specific to Quality Assurance GCP and GLP.  Experience in Clinical and non-clinical Quality Oversight required.
  • Strong understanding and knowledge of GLP/GCP/ICH regulations and an ability to apply them to non-clinical/clinical research and/or related processes is required.  Inspection experience in hosting regulatory authority inspections.
  • CAPA Development and Management experience.
  • Strong verbal and written communication skills, including exceptional interpersonal skills and problem-solving capabilities, are essential.
  • Excellent organization and multi-tasking skills.
  • Ability to work independently and prioritize with minimal daily instruction.
  • Ability to think strategically in order to improve current processes.
  • Possible travel required (up to 30%).