Job Description

Job Description Summary

This position is responsible for leading the Quality team, ensuring compliant processes, team management, and oversight of Quality compliance and operations in support of EU, FDA, Clinical Trial, CLIA/CAP, state, and ISO requirements. Responsibilities include managing personnel and compliance for assay validation, clinical study development and testing, IVD manufacturing, and overall Quality Systems (change control, CAPA, equipment, computerized systems, etc.).

Job Description

Major accountabilities:

1. Work in a GCP/CLIA/GCLP/IVD GMP regulated environment, overseeing all applicable regulations.
2. Implement and maintain quality metrics, systems, and documentation related to clinical trials, including procedures, processes, tests, equipment, materials, regulatory requirements, and staffing proficiency.
3. Develop and conduct GxP, CLIA, IVD Manufacturing, and GCLP training across all lab areas to ensure regulatory compliance.
4. Manage, create, and ensure appropriateness of procedures related to Clinical Trials and IVDs; provide quality and regulatory assessments for laboratory policies and procedures.
5. Serve as a quality liaison with regulatory agencies and sponsors.
6. Maintain appropriate state licenses for a CLIA medical laboratory and CAP and ISO accreditations.
7. Manage staff to ensure timely delivery of responsibilities including product release, IVD design control and manufacturing, and compliance of partner laboratories.
8. Provide quality assessment for assay/product validations.
9. Establish and maintain Quality Systems to meet regulatory requirements, including IVD GMP, GCP, CLIA, and CAP.
10. Oversee, host, and lead regulatory inspections/audits, perform internal GMP, GCLP, and CLIA compliance audits, and work with internal departments to resolve/correct issues.
11. Identify, design, and implement opportunities for improvement across all areas of responsibility.
12. Develop metrics, reports, charts, and documentation for Quality Management Review.
13. Ensure complete and compliant documentation supporting internal audits, change control, and incident management.

Key performance indicators:

1. Provide strategic and managerial leadership for Navigate in all Quality matters, ensuring compliance with applicable requirements.
2. Oversee Navigate's Quality Management System, leading company objectives and adapting to regulatory changes.
3. Build strong internal and external quality partnerships with stakeholders, sponsors, and regulatory agencies.
4. Manage inspections, audits, deviations, incidents, and permits/licenses maintenance effectively.

Minimum Requirements:

Work Experience:

• At least 12 years of progressively responsible experience in a regulated Quality Assurance role, preferably GCP.
• At least 7 years of specific experience supporting GCLP in clinical trials.
• At least 5 years of leadership and supervisory experience.
• CLS license preferred.
• Experience with IVD, especially Companion Diagnostics, preferred.

Skills:

• Detail-oriented with the ability to manage multiple projects.
• Strong leadership and people management skills across all Quality areas.
• Ability to collaborate effectively with leadership and partners.
• Strong understanding of Clinical Labs supporting drug development (GCP / GCLP / CLIA).
• Experience managing and hosting regulatory and sponsor audits.
• Decision-making skills with a focus on risk, operations, and compliance.
• Team development and leadership capabilities.

Languages :

• English.

EEO Statement:

The Novartis Group of Companies are Equal Opportunity Employers committed to diversity and inclusion. We do not discriminate based on race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or other protected statuses. We strive to create an inclusive workplace fostering innovation and empowering our employees.

Accessibility and accommodations:

We are committed to providing reasonable accommodations for individuals with disabilities. If needed, contact tas.nacomms@novartis.com or call +1 (877) 395-2339, including the job requisition number in your message.

Salary Range

$192,000.00 - $288,000.00

Skills Desired

Auditing, Compliance, Business Partnerships, Strategies, Communication, Continuous Learning, Decision Making, Employee Performance, Financial Acumen, GMP Procedures, Goal-Oriented, Problem Solving, Health Authorities, Leadership, Logical Thinking, Incident Management, Managing Ambiguity, People Management, Quality Assurance, Speed and Agility, Stakeholder Management, and more.

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