GeneCoda has been engaged to identify and evaluate candidates for a Manager / Senior Manager of GCP Quality to be located in the Research Triangle Park, NC area.
About Our Client:
Our client is an innovative, commercial-stage biopharmaceutical company developing medically important pharmaceutical products in Oncology and other therapeutic areas with unmet needs.
The Manager / Senior Manager of GCP Quality is responsible for leading the independent QA oversight of internal and external Good Clinical Practices (GCP) and assuring compliance of projects with applicable worldwide regulations and guidelines (e.g. FDA, EMA, ICH, national regulators).
- In partnership with internal clinical operations, medical monitors, drug safety, and pharmacovigilance, carry out quality plans for oversight of internal and external clinical activities.
- Facilitate a suite of inspection readiness activities with various stakeholders.
- Preparation and support of regulatory inspections of company and vendors, as necessary.
- Participate in Back Room management of sponsor inspections.
- Facilitate analysis of existing GCP systems and processes for PAI risk and support mitigation plans.
- Recommend sites for enhanced quality oversight (i.e. audits, QA reviews); manage the clinical site audit schedule.
- Support the development of quality metrics and report quality activity status updates to clinical quality management.
- Based on knowledge of regulations, guidelines and relevant SOPs, act as a technical resource for clinical study GCP-related issues.
- Proactively identify and escalate quality issues and discrepancies, as appropriate.
- Ensure clinical development compliance with all applicable regulations and standards.
- Oversee clinical trial systems and processes to ensure alignment with protocol data requirements and promote regulatory compliance for all clinical trials.
- Participate in the development of configuration, testing, or validation activities for GXP Clinical systems such as EDC, IXRS, or eTMF.
- Provide clinical quality review of clinical study documents.
- Participate in clinical study meetings as a clinical quality lead.
- Contribute to the development, implementation, and maintenance of GCP quality SOPs.
- Light travel expected.
Education: Bachelor of Science degree in a scientific discipline, technology, engineering, or related field.
Experience and Qualifications:
- 5 or more years of direct experience in GCP activities, quality systems and oversight of drug development lifecycle, clinical research, or clinical study monitoring.
- Expertise in GCP, health authority regulations, and ICH guidelines.
- Strong collaborative skills. Team player mentality.
- Ability to troubleshoot, identify root causes and systematically resolve problems.
- Ability to prioritize, organize and manage multiple projects simultaneously.
- Excellent interpersonal skills.
- Excellent verbal and written communication skills.
GeneCoda refers qualified applicants for all jobs without regard to race, color, religion, creed, age, sex, disability, marital status, national origin, pregnancy, family medical history or genetic information, sexual orientation or preference, Vietnam Era Veteran status or other protected military status or any other status protected by federal, state, or local law.