Director/Senior Director, Quality Assurance GCP

Our client is a leading specialty biopharmaceutical company. They have asked us to assist them in their search for a Director/Senior Director, Quality Assurance GCP.

Major tasks and responsibilities will include:
  • Participates in the development, implementation, and maintenance of GCP Quality Systems and Standard Operating Procedures.
  • Acts to educate and mentor staff on global GCP rules and guidelines.
  • Conducts audits to ensure that CROs, clinical sites and supporting services are acceptable for performing clinical studies and related services and to ensure they operate in compliance with the company’s quality program, regulations/guidelines and Standard Operating Procedures.
  • Provides Quality Assurance supervision and reviewing of eTMFs.
  • Oversees consultant facilitated audits; follows up on corrective actions.
  • Leads preparations for Clinical Operations inspection-readiness.
  • Leads and manages GCP Inspections.
  • Serves as an SME for areas of responsibility during regulatory inspections, and directly manage inspection Ready -Room activities.
  • Collaborates with other teams to designs and implement a risk-based clinical Quality Assurance management system.
  • Identifies QA and compliance associated issues and implements solutions to ensure timelines are maintained.
  • Establishes metrics.
  • Communicates to senior management the state of GCP Quality and compliance of clinical trials.
  • Ensures Clinical Operations events are compliant with regulations, guidelines and industry standards.
  • Reviews key safety, clinical and regulatory documents, such as DSUR, IB, IND and NDA.
  • Interprets regulations and guidelines, as they apply to GCP, awareness of regional regulatory requirement, and phase of study.
  • Keeps well-informed of industry developments including upcoming regulations, guidance, best practices, etc.

We seek candidates with the following qualifications:
  • Must have a Bachelor's degree in a relevant field.
  • A Master’s degree or PhD in a clinical/medical science is highly preferred.
  • Requires relevant industry experience.
  • Must have experience managing Health Authority GCP Inspections.
  • Requires experience leading document review (Source data verification) initiatives.
  • Requires excellent communication, writing and presentation skills for effectively interfacing with internal and external organizations, collaborators and customers.
  • Must have the demonstrated ability to work independently and in a team environment and seek resources, as necessary.
  • Requires the ability to assess complex issues, break down into components and propose viable solutions.
  • Requires the demonstrated ability to lead and organize team meetings.
  • The ability to foster effective relationships with vendors, investigators and colleagues is required.
  • Must have excellent knowledge of Global GCP regulations and industry standards.
  • Proficiency in study monitoring activities is required.
  • Must have demonstrated effective time management skills.
  • Requires strong professionalism and interpersonal skills.
  • Sound judgment and commitment to ethical conduct is required.
  • Must be willing to travel domestically and internationally up to 25%.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.

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