Supports QA Leadership in the risk-based Clinical Quality Assurance (CQA) oversight for internal and external process and systems supporting Immunomedics clinical trials. Provides GCP compliance support to Clinical development and operations, including GCP QMS (quality manual, SOPs, WPs, etc.) development/maintenance. Actively contributes to the risk-based GCP audit program, including CAPA, GCP training and inspection readiness. Provides day to day compliance support to Clinical study teams and cross-functionally to other functional areas, e.g., clinical supplies, Regulatory, PV, medical affairs.
Responsibilities: 1. Supports CQA management in the development of goals and objectives for the department in alignment with corporate goals and objectives.
2. Contributes to the strategic planning, assignment, and performs/reports GCP audits of Phase I IV clinical studies, e.g., clinical investigator sites, vendors/CROs, internal system/processes and clinical documents or data, including CAPA evaluation and follow-up.
3. Provides GCP support, compliance direction and coaching to Immunomedics staff involved in clinical trials.
4. Develops and/or updates procedural documents and tools (e.g., SOP, WP, templates, forms) to incorporate into the overall Immunomedics quality management system. Schedules training, as needed.
5. Leads/performs for-cause audits or other high-profile audits, projects and/or special investigations to evaluate noncompliance, root cause identification, and reports results to management.
6. Tracks and evaluates aggregate CAPA and audit observations trends to develop periodic compliance/metric reports, as requested by CQA management.
7. Contributes to the identification and communication of lessons learned from audits and inspections and provides expert advice/information to CQA and Clinical study staff.
8. Evaluates impact of new regulations/guidances, as well as audit results/trends on the business and regulatory risks and provides ongoing guidance.
9. Gives guidance and support to Clinical and other departments on data integrity and Good Documentation Practices.
10. Prepares for FDA and other regulatory agency audits and inspections. Leads, manages and/or coordinates global HA GCP inspectional activities, coaches staff and provides assessment of reports and results from Health Authority Inspections, including the associated risks and recommendations to relevant management.
11. Responsible for training/orientation/mentoring of newly hired CQA auditors and participates in GCP training program of Immunomedics groups.
12. As requested, may perform additional responsibilities as requested by CQA management.
13. Demonstrates and promotes Immunomedics values and behaviors during all CQA activities.
14. Travel approximately 30%, domestic and international.
• Extensive working knowledge of applicable global GCP guidelines/regulations and training, including practical understanding of GCP ICH E6R2 and risk-based Quality approach
• CQA Management and hands-on CQA Operations and CQA Systems experience including auditing and inspection readiness within pharmaceutical or Biotechnology Company
• At least two (2) years supervisory experience
• BS in Life Sciences or equivalent with 5+ years related experience within a pharmaceutical or Biotechnology Company
• Experience in CQA Operations and CQA Systems, including supporting audits and inspections within pharmaceutical or biotechnology company. At least two (2) years supervisory experience
• Additional technical experience in an area allied with global GCP Quality, Quality Systems, 21 CFR Part 11, 50, 54, 56, 312, 314, ICH E6 (R2) guidelines
• Experience with international clinical study compliance preferred
• Experience with GVP compliance preferred
• Must be fluent in English language with strong verbal and written communication skills