343255BR
Jun 24, 2022
USA

Job Description

766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives. We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!

The Quality Operations GMP and Data Integrity Officer is responsible for first level, hands on, day-to-day cGMP facilitator role for all site related GMP activities.

Your responsibilities include, but are not limited to:

This position will be expected to work a 5 days/8 hour work shift. Weekend support and some evenings are required.
• Provides oversight to operations on the production and QC shop floor, supporting operators and support staff as needed to identify and address product quality and compliance issues as they arise.
• Review and audit production batch records, and/or QC related documentation, to ensure adherence to Novartis policies, SOPs, and cGMP requirements.
• Oversight of aseptic operations including but not limited to ViMOS, APV program, EM program, walkthrough program, etc.
• Triaging of issues, initiate deviation reports into the system and partner with PU, and other areas for issue resolution.
• Actively participate in process improvement initiatives aiming for Right First Time (RFT) on documentation and deviation reduction in collaboration with Process Expert teams.
• Present systems and provide documentation for self-inspections and external audits.
• Interact with FDA, partner, and supplier auditors/inspectors, as needed.
• Drive, monitor and assure delivery of the AAA DI Plan, including DI communication and engagement plan, and periodically report status / progress to AAA leadership through the AAA SQRB, TechOPS Business review and Novartis Group Quality as required. Support Escalation
• Continuously improve data integrity knowledge base and understanding: Identify training needs, and ensure availability of appropriate and functionally relevant training materials; where training does not exist, facilitate creation of material and delivery of training.
• Drive sustainable improvement in detecting and mitigating DI risk by working with SMEs to embed DI focus in existing site programs, for example, self-inspection program, continuous improvement program, Gemba walks, VIMOS, etc.


https://www.youtube.com/watch?v=4A1joFLTfo0

Diversity & Inclusion / EEO

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.

Minimum Requirements

What you'll bring to the role:

Bachelor's Degree in life sciences, Engineering, Chemistry, Pharmaceutical required
• 5 + years of experience in a Pharmaceuticals environment.
• Strong knowledge and understanding of cGMPs, keeping up to date with current industry
issues and changing regulations.

Why Advanced Accelerator Applications (AAA)?
Thousands of people die of cancer around the world every day. At Advanced Accelerator Applications (AAA), a Novartis company, our mission is to transform lives through radioligand therapy in nuclear medicine to fight several leading types of cancer. How will we continue to be on the cutting edge of medicine?
We believe new groundbreaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!

Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity, and inclusion. 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 [email protected] 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.

Join our Novartis Network:
If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
ONCOLOGY
ADVANCED ACCELERATOR APPLICATIONS
USA
Millburn, NJ
Quality
Full Time
Regular
No
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343255BR

GMP and Data Integrity Officer

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