Manager / Sr. Manager, Clinical Quality Assurance - GMP

Immunomedics, Inc. Morris Plains , NJ 07950

Posted 2 months ago

Overview

The Manager/Sr. Manager Quality Assurance Clinical GMP will work in all phase of clinical development to provide quality oversight for clinical packaging and supply chain activities.

Actively contributes and supports QA Leadership in the risk-based Clinical Quality Assurance (CQA) oversight for internal and external GMP process and systems supporting Immunomedics clinical trials. Provides GMP compliance support to Clinical development and operations, including QMS development/maintenance. Provides day to day compliance support to Supply Chain, Clinical study teams and cross-functionally to other functional areas, e.g., Regulatory, medical affairs.

Responsibilities
1.Lead clinical GMP quality system (Quality Manual, SOPs, WPs, etc.) development, including process mapping to ensure Clinical quality systems are compliant with regulatory requirements and industry standards, including process for IMP supply disposition, audit program, CAPAs, complaints, investigations, etc.2. Function as the Quality department liaison to other departments including but not limited to Quality Control, Manufacturing operations, vendor/supplier quality and external QPs3. Author, coordinate, negotiate, and maintain quality agreements between Immunomedics and 3rd party vendor/suppliers, QPs, etc.4. Perform the quality review of batch records (master and executed) for IMP lot release and label review/approvals, as well as deviations, investigations, and change controls 5. Assess/review/approve CAPAs, major/critical deviations, investigations and change controls; and evaluate product quality and program impact, escalate as needed to Sr Management6. Coordinate the investigation and closure of deviations with specific emphasis on comprehensive root cause analysis. Ensure appropriate Corrective and Preventive Actions (CAPA) are initiated, implemented, monitored and update internal trackers7. Support quality deliverables for shelf-life extensions, including review and approval of internal document updates and external labeling/relabeling activities8. Conduct audits of internal process or external CMO/Vendor/Supplier/analytical laboratory or participate as member of the audit team and/or subject matter expert; and management of vendor qualification program 9. Ensure tracking of audits, findings and corrective and preventive actions and maintain records on the CQA tracking System10. Conduct quality reviews of regulatory submissions for IND/IMPD/NDAs and periodic updates, as applicable11. Evaluate IMP transport and storage temperature excursions and communicate decision for use to internal Immunomedics clinical teams and/or CRO/Vendors12. Ensure inspection readiness of vendors conducting GMP Clinical activities through metrics review, vendor audit findings, CAPA generation and review13. Maintain high level of knowledge of current GMP global regulations/guidances, as well as audit results/trends on the risks and provide ongoing guidance14. Coordinate, compile and present (as needed) clinical GMP quality metrics and trending15. As requested, may perform additional responsibilities as requested by CQA management16. Demonstrates and promotes Immunomedics values and behaviors during all CQA activities17. Travel approximately 30%, domestic and international

Supervisory Responsibilities:
As assigned, carries out supervisory responsibilities in accordance with the department-set goals. Responsibilities include interviewing potential employees; employee training and development; planning, assigning, and directing work; appraising performance; rewarding and disciplining; corrective action and complaint resolution.

Qualifications

  • BS in Life Sciences or equivalent with 5+ years related experience within a pharmaceutical or Biotechnology Company

  • Thorough understanding of Good Manufacturing Practices (GMP) 21 CFR 210/211, 312, EudraLex Volume 4 (including relevant parts and annexes) and ICH; including Good Documentation Practices (GDP) and Data Integrity Thorough understanding of 21 CFR Part 11 and Annex 11, computerized system validation

  • Ability to work independently and set priorities across multiple projects with little supervision. Exhibits leadership skills that promotes team collaboration, fosters open dialog, maintains an inclusive collaborative environment Must work effectively/collaboratively in a fast-paced team environment and with individuals at all levels within an organization.

    Expert knowledge of FDA and EU legislation and ICH related to role Prior NDA / MAA experience preferred. Strong analytical and problem-solving skills with attention to detail Additional technical experience in an area allied with global GCP and/or PV Quality Must be fluent in English language with strong verbal, written technical communication

  • Thorough understanding of Good Manufacturing Practices (GMP) 21 CFR 210/211, 312, EudraLex Volume 4 (including relevant parts and annexes) and ICH; including Good Documentation Practices (GDP) and Data Integrity Thorough understanding of 21 CFR Part 11 and Annex 11, computerized system validation

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