750 million. That's how many lives our products touch. And while we're proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people's lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you're given opportunities to explore the power of digital and data. Where you're empowered to risk failure by taking smart risks, and where you're surrounded by people who share your determination to tackle the world's toughest medical challenges.
The Novartis Cell & Gene Technical Development and Manufacturing team is seeking a QA Compliance Specialist in Morris Plains, NJ.
What you'll be doing
QA Compliance Specialist is responsible for establishing and maintaining robust oversight and governance of Deviations and CAPA Management Processes at Morris Plains Site. Investigators certification process management, responsible for ensure proper training and certify the deviations investigators at Morris Plains Site, ensuring the certified status maintenance through periodical evaluations.
Responsible for CAPA System Management (Oversight and Governance), and perform follow-up activities to ensure a continuous quality improvement lifecycle of the CAPA System is being maintained. Facilitate and provide guidance to cross functional Departments around CAPA development, in order to continually improve the health of the Quality System; Primary lead of CAPA Governance Board and Key Leader in Compliance Sustainability Program (CAPA Board); Deviation/CAPA Quality Systems Owner (QSO) and Business Process Owner, responsible Responsible to enhance the Deviation/CAPA Process and Training/Onboarding Associates in Deviation and CAPA process/handling as a key GMP building block; Perform weekly and monthly KPIs metrics, reporting it to Quality Review Board and Site Quality Committee Elaborate deviation trending reports on quarterly basis and recommend corrective actions based on the outcome of the trending reports; Deviation, CAPA and Quality Events SOPs ownership and governance.
Key member contributing to CGTDM platform GOPs Implementation; APQR contributor for the CAPA review session; Investigator certification process management, providing training and certifying the investigators at Morris Plains Site, and ensure the certified status maintenance thought periodical evaluations. Back-up for Complaint and escalations Oversight/governance.
Number of Overdue CAPA's/Quality Events; Training Monthly Reports/Verification/Trend Reports;
Bachelor's Degree or equivalent 4year degree required in Pharmacy, Biochemistry, Chemistry, Biology, Engineering or other related life science degree. Advanced degree preferred Fluent in English 3 years experience in the pharmaceutical industry with direct experience with Compliance and Quality Systems; Aseptic experience preferred. Experience in drug development, clinical, manufacturing, outsourcing and/or other relevant operational areas; Deep experience in deviation investigations; root cause analysis tools and Deviations & CAPA management; Thorough knowledge GMP requirements;