Job Description Summary

The Head of Quality Control is responsible for designing and implementing innovative and robust processes for testing activities associated with a viral gene therapy manufacturing site which includes bulk product and sterile fill operations.

Location- Durham, NC #LI- onsite

Job Description

Key Responsibilities:

Develops and executes corporate quality policies, practices, procedures, standards, and systems necessary to ensure adherence to aseptic production and product management in accordance with the cGXP compliance to US and EU regulations.
Oversees the testing and validation strategy, with a concentrated focus on method verification and validation.
Maintains a robust Environmental Monitoring program that meet US/EU and other applicable regulatory requirements.
Organizes and directs cross functional relationships with Manufacturing, Engineering, MS&T, Quality Assurance, and Regulatory.
Hires staff and manages contract vendors for programs related to focus area.
Directs laboratory staff, set goals and expectations, and maintain efficient utilization of resources.
Authors and approve documents required for regulatory submissions.
Develops, implements, and ensures laboratory procedures and policies are followed.
Provides presentations, explain laboratory qualification and operations, and defend testing results during FDA and other inspections.
Other duties for which QC is responsible, as assigned.

Requirements:

BS/MS in Microbiology discipline and 12 years of related experience in cGMP laboratory environment, with strong knowledge of regulatory, USP and Eur. Phr guidelines (Ph.D. in life sciences is preferred).
8 years of laboratory management experience.
Experience starting up lab facilities supporting clinical and/or commercial manufacturing.
Experience with regulatory agency inspections.

Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $138,600 and $257,400 /year; however, while salary ranges are effective from 1/1/25 through 12/31/25, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills, and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

EEO Statement:

The Novartis Group of Companies are Equal Opportunity Employers who are focused on building and advancing a culture of inclusion that values and celebrates individual differences, uniqueness, backgrounds and perspectives. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to fostering a diverse and inclusive workplace that reflects the world around us and connects us to the patients, customers and communities we serve.

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 to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or 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.

Salary Range

$138,600.00 - $257,400.00

Skills Desired

Audit Management, Communication Skills, Continued Learning, Dealing With Ambiguity, Decision Making Skills, Employee Performance Evaluations, Gmp Procedures, Inspection Readiness, Organizational Skills, People Management, People Management and Leadership, Product Release, Qa (Quality Assurance), Self-Awareness, Technological Expertise