347411BR
Aug 16, 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!

Responsible for oversight of the local quality systems governing manufacturing, testing, and supply chain operations to ensure compliance with current GMP regulations, Novartis and AAA processes, procedures, and quality systems, and all applicable health authority regulations and guidelines.

Your responsibilities include, but are not limited to:
Work closely with the production, quality control and supply chain departments to ensure their practice fully adheres to cGMP, including data integrity & eCompliance.
•Lead the creation, maintenance, and implementation of local Standard Operating Procedures(SOPs), leading gap assessments, and maintaining alignment with the Novartis quality manual, Novartis and AAA global/corporate procedures, and health authority regulations and guidance.
•Champion AAA’s Good Documentation Practices and Data Integrity programs for the site, ensuring all employees working with controlled documentation are trained and compliant with all related requirements
•Provide leadership to site implementations of document control initiatives, including: oNovartis’ DocStore CONDOR (Controlled Document Repository) system and migrating as relevant from AAA’s DMS (Ennov); Novartis CIRF (Controlled Issuance & Reconciliation of Forms) system; Novartis SubWay (Regulatory submission document repository) system, including data migration as relevant from Ennov; Novartis Electronic SOPs (ESOPs), including migrations from Ennov
•Lead the programs for issuance, maintenance, review, and archival of logbooks and other controlled records for the site
•Proceduralize and manage a quality system for the logging, scanning, and on-site archival of AAA Millburn’s controlled documents (e.g. batch records, change control, deviations, CAPA,validation records, et al.) as well as off-site archival and retrieval (e.g. Iron Mountain)
•Provide support for change control, deviations, CAPA, Annual Product Review (APR) activities,and maintain a state of audit/inspection readiness
•Ensure timely closure of logbooks, QS records, and investigations, and escalate issues to management when required
•Conducting self-inspections and spot-auditing of records and logbooks as needed to ensure compliance is maintained
•Provide backup support for other QA Compliance Management members, as needed
•Collaborate with the AAA Indianapolis site to ensure meaningfully consistent deployment of systems and local/regional processes

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 a scientific or health related field
6+ years of relevant GMP work experience, or relevant comparable background of which •4+ years are preferably in Quality Assurance/Compliance and documentation control •Experience conducting quality investigations, root cause analyses, and quality risk assessments
•Thorough knowledge of GMP and Good Documentation Practices. •Strong personal ethics and responsibility
•Digital & technology savviness

Preferred:
•QA, QC, and/or Production experience in biotech/pharmaceutical industry with environmental monitoring &cleanliness zones. Experience with radiopharmaceuticals is a +. •Practical experience in establishing and maintaining quality systems, as well as successfully supporting Health Authority inspections from e.g.: USA, EMEA, Canada, Japan, Brazil. •Excellent and effective interpersonal and communication skills •Track record of fostering collaboration and alliance across internal departments. Proven ability to assess quality needs and gaps and propose compliant solutions.
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.

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]
ONCOLOGY
ADVANCED ACCELERATOR APPLICATIONS
USA
Millburn, NJ
Quality
Full Time
Regular
No
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347411BR

Manager, QA Compliance-Document Control

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