Director/Senior Director, GCP Clinical Quality Assurance
Our client is a biotechnology company aimed at developing medicines targeting metabolic and age-related disorders. They have asked us to assist them in their search for a Director/Senior Director, GCP Clinical Quality Assurance.
Major tasks and responsibilities include:
We seek candidates with the following qualifications:
- Develops resourcing plans and prepares annual budgets to support product plans and annual goals in partnership with Quality Management team.
- Builds and maintains a GCP organization by hiring, mentoring, and coaching experienced staff.
- Oversees day-to-day activities to partner with all relevant functions within the Development and Medical organizations.
- Creates inspection management program, performs inspection readiness activities, and manages/participates in global regulatory inspections.
- Performs Clinical Quality duties to assist with regulatory dossier preparation, including NDA/MAA.
- Implements regulatory intelligence and analytics tools to champion data-based decision-making and to be current with regulatory guidance.
- Represents Clinical Quality Assurance in cross functional meetings and discussions, as needed.
- Coaches staff to resolve complex problems where analysis of situations or data requires an in-depth multifactorial evaluation.
- Exercises sound and balanced judgment in ensuring that written procedures are followed and in evaluating quality systems, processes, procedures, plans and protocols for applicability and compliance.
- Works closely with cross functional teams and project/program leads.
- Develops and manages a robust and compliant clinical quality system to manage significant Quality Events (SQEs), CAPAs, audits, integrated Quality Risk management (QRM) plans and escalation processes.
- Partners with Development and Medical functions on the execution of study protocols, development of Standard Operating Procedures (SOPs), internal training, and review of electronic Trial Master File (eTMF) to ensure high quality and efficient clinical trial execution.
- Leads routine and for cause audits of investigator sites, vendors, lead, internal audits, etc.
- Reviews key clinical study documents as part of a quality assurance step, including clinical study protocols, informed consent templates, investigators’ brochures, clinical study reports, and regulatory submission modules.
- Escalates significant compliance issues and system deficiencies to senior management, as appropriate.
- A Bachelor’s degree in Life Sciences or related discipline is required. An advanced degree is preferred.
- Requires at least 12 years of progressive pharmaceutical experience in a clinical/nonclinical development arena.
- Must have a minimum of ten years within GCP/GLP or GVP roles, inclusive of developing quality systems and robust organization.
- A minimum of five years of exposure of regulatory authority inspections and inspection readiness is preferred.
- Must be a nimble collaborator with strong interpersonal and exceptional leadership skills with proven ability of building and maintaining a robust GCP QA team within a Global QA organization.
- Must have experience managing/participating in global regulatory inspections.
- Prior experience collaborating with cross functional teams supporting regulatory dossier preparation, including NDA/MAA, is required.
- Requires an excellent working knowledge of GCP/GLP and GVP requirements and ICH guidelines.
- Must have diligence, excellent review skills, and the ability to organize and manage multiple tasks in a challenging environment.
- Broad experience in the pharmaceutical industry with a strong clinical development understanding, including direct experience working on global, late-stage clinical trials, is required.
- Must be meticulous with analytical and critical thinking skills with the ability to work effectively in a demanding environment with initiative and great organization skills.
- The ability to deal with ambiguity enabling creative and pragmatic approach to problem solving is required.
- Requires excellent verbal and written communication with the ability to write clearly and summarize information effectively.
- Must be proficient with computers and typical office software.
- Requires the ability to communicate with staff at all levels including the ability to articulate Clinical QA updates cross functionally.
- Must be able to present complex information to various audiences.
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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