Manager, QC Technical Support
Company: Novartis Group Companies
Location: Durham
Posted on: April 26, 2024
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Job Description:
394675BR
Manager, QC Technical Support
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:
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
Keywords: Novartis Group Companies, Chapel Hill , Manager, QC Technical Support, Executive , Durham, North Carolina
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