Senior Quality Assurance Manager

3 weeks ago

Carlsbad, United States Novartis Farmacéutica Full time

Job Summary

This position is responsible for leading the Quality team to ensure compliant processes, team management, and oversight of the Quality compliance and Quality operations in support of EU, FDA, Clinical Trial, CLIA/CAP, state, and ISO compliance requirements.

Key Responsibilities

  • Manage personnel and compliance for assay validation, clinical study development and testing, IVD manufacturing, and overall Quality Systems (change control, CAPA, equipment, computerized systems, etc.).
  • Implement and maintain quality metrics, systems, and documentation associated with clinical trials, including procedures, processes, tests, equipment, materials, regulatory requirements, and staffing proficiency.
  • Develop and conduct GxP, CLIA, IVD Manufacturing, and GCLP training across all lab areas to ensure compliance with regulatory requirements.
  • Manage, create, and ensure the appropriateness of procedures related to Clinical Trials and IVDs. Provide quality and regulatory assessment for laboratory policies and procedures.
  • Serve as quality liaison with regulatory agencies and sponsors.
  • Maintain appropriate state licenses for a CLIA medical laboratory and CAP and ISO accreditations.
  • Manage staff to ensure timely delivery of assigned responsibilities, including product release, IVD design control and manufacturing, and compliance, including that of partner laboratories.
  • Provide quality assessment for assay/product validations.
  • Establish and maintain Quality Systems to meet regulatory requirements, including IVD GMP, GCP, CLIA, and CAP.
  • Oversee, host, and/or lead regulatory, sponsor, external vendor, and/or partner lab inspections/audits, and perform related internal GMP, GCLP, and CLIA Regulatory Compliance Audits. Work with internal departments as needed to identify and resolve/completed corrective actions. Assist with other internal audits as needed.
  • Identify, design, and implement opportunities for improvement across all areas of responsibility.
  • Develop metrics, reports, charts, and/or related documentation as needed for Quality Management Review.
  • Ensure complete and compliant documentation in support of internal auditing, change control, and incident management.

Requirements

  • Minimum of twelve (12) years progressively responsible experience in a related Quality Assurance role in a regulated environment, preferably GCP.
  • Minimum of seven (7) years specifically related experience with clinical trials supporting GCLP.
  • Minimum of five (5) years with leadership and direct supervisory experience.
  • Skills: detail and goal-oriented with ability to manage multiple projects at one time, people leadership across all areas of Quality, ability to contribute to Navigate leadership and partner with other leaders, strong agility, collaboration, and teamwork, clear understanding of Clinical Labs in support of drug development clinical trials (GCP / GCLP / CLIA).

Language: English

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