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Manager, QA Compliance-Document Control (347411BR)

Management

Manager

Yearly

No

Millburn, New Jersey, United States

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. <br>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!<br>Imagine what you could do here at Novartis! <br><br>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.<br> <br>Your responsibilities include, but are not limited to:<br>Work closely with the production, quality control and supply chain departments to ensure their practice fully adheres to cGMP, including data integrity & eCompliance.<br>•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.<br>•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<br>•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<br>•Lead the programs for issuance, maintenance, review, and archival of logbooks and other controlled records for the site<br>•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)<br>•Provide support for change control, deviations, CAPA, Annual Product Review (APR) activities,and maintain a state of audit/inspection readiness<br>•Ensure timely closure of logbooks, QS records, and investigations, and escalate issues to management when required<br>•Conducting self-inspections and spot-auditing of records and logbooks as needed to ensure compliance is maintained<br>•Provide backup support for other QA Compliance Management members, as needed<br>•Collaborate with the AAA Indianapolis site to ensure meaningfully consistent deployment of systems and local/regional processes