Major accountabilities:

• Works in a GCP/CLIA/GCLP/IVD GMP regulated environment and is responsible for oversight of all applicable regulations.
• Implement and maintain quality metrics, systems and documentation associated with clinical trials, including, but not limited to 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 to regulatory requirements.
• Manage, create and ensure 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 deliverance 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 / complete 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

Key performance indicators:

• Provide successful strategic and managerial leadership for Navigate in all Quality related matters and ensure that all aspects of the operational business comply with applicable compliance and regulatory requirements.
• Successful oversight of Navigate's Quality Management System; Perform leadership and strategic responsibilities related to company objectives and changing regulatory requirements.
• Successful Quality partnership internally with all stakeholders, and externally with all Sponsors and Regulatory agencies.
• Successful oversight of all inspections/audits, management of deviations and incidents, and maintenance of applicable permits and licenses.

Minimum Requirements:
Work Experience:

• 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
• CLS license desired
• IVD experience desired (Companion Diagnostics)

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)
• Strong experience in managing and hosting Sponsor and Regulatory audits
• Strong experience managing internal auditing for GCP studies (study monitoring)
• Decision making skills understanding risk, operational practices, and compliance
• Team development and leadership

Languages :

• English.

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