Job Description Summary

This position is responsible for leading the Quality team ensuring compliant process, 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. Responsibilities include the management of 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:

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.

EEO Statement:

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Accessibility and reasonable accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to tas.nacomms@novartis.com call +1 (877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

https://www.novartis.com/careers/careers-research/notice-all-applicants-us-job-openings

Salary Range

$192,000.00 - $288,000.00

Skills Desired

Auditing, Auditing, Audits Compliance, Business Partnerships, Business Strategies, Commercial Acumen, Communication, Continuous Learning, Decision Making, Employee Performance Evaluations, Financial Acumen, Gmp Procedures, Goal-Oriented, Group Problem Solving, Health Authorities, Leadership, Logical Thinking, Major Incident Management, Managing Ambiguity, People Management, Qa (Quality Assurance), Self-Awareness, Smart Risk Taking, Speed and Agility Training, Stakeholder Management {+ 5 more}