394675BR

USA

About the role

The Manager, QC (Quality Control) Technical Support and Compliance, provides technical leadership and guidance to the QC team by ensuring that continuous improvement projects are identified and implemented and that new changes/projects are assessed taking into consideration operating model and impact to cGMPs, SOPs and applicable guidelines and normative.
Leads Quality Control technical support team to support QC and AS&T, and interface with support groups to implement changes and continuous improvement processes.
* Act as Subject Matter Expert (SME) for the product and process results, be highly knowledgeable of trends by providing input for analysis and driving innovations.
* Authors QC investigations and meets all targets for timely closure and CAPA completion.
* Works with the QC team to prioritize/coordinate of updates of SOP, WP, Form, etc. updates.
* Support regulatory inspections.
* Oversees and coordinates change control for method related changes.
* Perform technical review and approval of QC assay results as needed.
* Fosters and supports a team culture that is engaged and empowered.
* Coordinate with Quality to ensure compliance and continuous improvement in the QC labs.

EEO Statement

We 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: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please let us know the nature of your request, your contact information and the job requisition number in your message:

• Novartis: e-mail us.reasonableaccommodations@novartis.com or call 1 (877)395-2339
• Sandoz: e-mail reasonable.accommodations@sandoz.com or call: 1-609-422-4098

Role Requirements

Bachelor's Degree in Biotechnology, Biopharmaceutical, Pharmaceutical Technology, Chemistry, Microbiology, Pharmacy or other Life Science-related scientific degree with 8 years of experience in pharmaceutical industry or equivalent and 2 years of direct supervisory experience.
* Knowledge of a process-oriented organization and a self-directed culture a plus.
* Proven process understanding (Pharma, GMP, Regulatory aspects).
* Project management, Operational Excellence, Product/Process Development or Regulatory experience a plus.
* Role models in accordance with Novartis Values & Behaviors.
The pay range for this position at commencement of employment is expected to be between $112,800 and $169,200 annual; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. 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.
Why Novartis: Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
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.

Division

Operations

Business Unit

QUALITY

Work Location

Durham, NC

Company/Legal Entity

Novartis Gene Therapies

Functional Area

Quality

Job Type

Full Time

Employment Type

Regular

Shift Work

No

Early Talent

No