353786BR
Dec 06, 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!

This role will provide quality assurance oversight and be accountable for supporting the Production, Engineering, and Supply Chain operations at AAA Millburn Site. The QA oversight will cover shop floor duties, compliance activity support, and duties related to routine product release. This role may also support QC operations as required, but the primary responsibility will oversee Production, Engineering and Supply Chain Operations. The QA Team Lead is also responsible for supervision of a team of QA personnel.

Your responsibilities include, but are not limited to:

Develop, maintain, and propose continuous improvement of quality systems and policies for production, engineering, and supply chain according to AAA Global Quality Standards, applicable local and global regulatory requirements, and registered Product information.
o Provide QA oversight of production, engineering, and supply chain operations through review/approval of test records for batch release, SOPs, C of As (as applicable), CAPAs, Deviations, change controls, and shop floor oversight. Provides the production, engineering, and supply chain teams with QA/Compliance guidance and decisions.
o Review and approve Standard Operating Procedures (SOPs), Quality Risk Assessments (QRAs), Quality Plans related to manufacturing operations, as needed. Contribute to generation of Annual Product Reviews for production, engineering and supply chain.
o Support training program for QA operations associates which include shop floor programs and training curricula, batch record review and release, and the validation program training curriculum as well as operational quality systems and compliance.
o Build collaborative interfaces with all stakeholders to ensure quality systems such as deviation management, investigations, corrective and preventive actions, and change controls are in place and followed.
o Drive continuous quality improvement program for manufacturing operations and partner with the production, engineering, and supply chain teams to implement/optimizes to improve efficiency (right the first time) and monitor/escalate as needed.
o Serve as SME for QA operations to support all regulatory inspections. Provide leadership during any periodic internal production, engineering, and supply chain self-inspections. Provide leadership and guidance during the preparation and participation of health authorities’ inspections Support and regulatory filings.
o Provide cGMP and associated OJT training to any other quality members and other operational areas as needed.
o Perform or support any other tasks necessary to maintain the product quality and site cGMP compliance, as needed.
o Act as a Deputy to Quality Assurance Head of Operation

Shop floor oversight is the focus of this role!
o Lead in establishing/implementing QA Operations programs related to shop floor programs which includes OVERSIGHT of ASEPTIC OPERATIONS, GEMBA walkthrough program, equipment/area/utility out of service program, QA area release of classified and unclassified areas, QA media fill oversight programs, event triage and support of routine operations.

Manages QA Shop Floor Team

Batch Record Review and Release:
o Lead in establishing/Implementing QA Operations programs related to batch record review and release activities which standardizes the review and release process to ensure efficient and timely product release for clinical and commercial products

Manages QA Product Release Team

Work schedule: Sunday - Thursday

Vaccine Policy: While Novartis does not require vaccination at this time, for certain Novartis sites in the US all associates and candidates may be required to either upload an image of their COVID-19 vaccine card demonstrating proof of full vaccination for COVID-19 (or other similar evidence of vaccination) or proof of a negative COVID-19 test taken by the associate or candidate within the past seven days to enter any of our sites and/or customer office or healthcare facility, as well as prior to participating in other work related off-site meetings. Employees working in customer-facing roles must adhere to and comply with customers’ (such as hospitals, physician offices, etc.) credentialing guidelines, which may require vaccination. As required by applicable law, Novartis will consider requests for reasonable accommodation for those unable to be vaccinated. This requirement is subject to applicable state and local laws and may not be applicable to employees working in certain jurisdictions. Please send accommodation requests to [email protected].

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:

Bachelors degree in Life Sciences. Masters degree a plus.
5-7 years of experience in GMP Pharmaceutical Manufacturing, at least 3 years combined of relevant experience in ASEPTIC GMP Manufacturing Operations and/or Quality Assurance covering GMP manufacturing operations with a proven track record of leadership in these roles
• Proven track record and practical experience in supporting a GMP Manufacturing Operations unit and operating in full compliance with global cGMP requirements. Successfully managed inspections by
major Health Authorities (e.g. US FDA, EMA)
• In-depth knowledge of cGMP, FDA regulations (21 CFR Parts 211, 212), and ICH regulations. In depth knowledge of QC regulations.
• Proven ability to manage multiple projects with moderate resource requirements, risk and/or complexity

**Prior supervisory experience preferred

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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353786BR

Manager, Quality Operations

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