Morris Plains, NJ, USA
Posted by: Matthew Masterson
09 Oct

Cell and Gene Therapy Compliance Lead

Morris Plains, NJ, USA
Job Description

3! The number of global Health Authority Inspections successfully hosted by the Cell and Gene Compliance group in Morris Plains so far in 2018! As part of the Cell and Gene Compliance team this role is critical for establishing and maintaining robust processes, oversight, and governance to ensure that all aspects of Morris Plains' cGxPs are in compliance with Novartis Quality Manual as well as Country specific Cell and Gene Therapy and Advanced Therapy Medicinal Product (ATMP) regulations.

Your Responsibilities:

Your responsibilities include, but not limited to:

• You will be the Primary Delegate for the Cell and Gene Therapy Compliance and Quality Management Systems Head. 

• You will lead your team by providing coaching and feedback to optimize performance. You will provide growth and development for your team using robust development plans. You will ensure your team is appropriately trained and has sufficient resources to be proficient in their roles.

• You will be responsible for management of all Health Authority inspections, Novartis Corporate Audits, and subsequent CAPA plans and management of personnel responsible for these activities. You will oversee/manage inspection readiness preparation and provide general inspection management oversight (e.g. front room and back room operations). You will also provide corporate audit support for East Hanover TRD/Pilot plant related operations. 

• You will ensure an annual Morris Plains self-inspection program is established, maintained and executed and management of the personnel responsible for this program; and provide support of East Hanover's self-inspection program as needed. 

• You will provide management and oversight of all escalations and personnel responsible for supporting and administrating escalation activities. You will manage and prepare any market action related documents, such as, Biological Product Deviation Reports (BPDR), Clinical Withdrawals, recalls, quality assessments, Drug Shortage notifications, support of Marketing Authorization Holder responsibilities and in alignment with the respective Country Organizations' process. 

• You will provide oversight and governance to personnel managing the Deviation, CAPA and complaint management Quality Systems. You will ensure a compliant and robust Deviation and CAPA management program exists. 

• You will ensure the compliance team has robust business processes and tools to manage the effectiveness of CAPAs, deviation trending, Root Cause Analysis all aimed at driving continuous improvement. • You will be responsible for the Deviation and CAPA training programs and ensuring your colleague effectively trains all new Morris Plains, East Hanover, and Apheresis associates on the use of the AQWA-Q Trackwise system and the use of the AQWA-A Trackwise system for management of all Health Authority, GCA and SI inspections and audits. 

• You will provide oversight to the associate responsible for completing of all Annual Product Quality Reports (APQRs) on time. 

• You will own the Site Master File and ensure it is accurate and current. 

• You will initiate corrective and preventative actions when necessary and perform follow-up activities to ensure a continuous quality improvement lifecycle is being maintained. Where relevant, ensure Recall & Returned product/materials are appropriately managed in accordance with GMP compliant practices and related Novartis QMs. Ensure mock recall is conducted as appropriate. 

• You will design and compile Key Performance Indicators (KPIs) and trend analysis for quality systems, Deviations, CAPAs, Overdue, complaint, Biological Product Deviation Reports (BPDR), GCA Audit Commitments, Health Authority Commitments, Self-Inspection. These are maintained and monitored to demonstrate the health of the related quality system. 

• You will provide support and information to the CPO/CGT QA Quality Committee/Quality Review Board, to the monthly MP Site Quality Committee and to the CGT Quarterly Review Board. 

You'll receive:

Competitive salary, annual bonus, robust benefits package including medical, dental, vision, and life insurance, a 401(K) and pension plan, and paid time off.

Why consider Novartis?

927 million. That's how many lives our products touched in 2017. And while we're proud of that, 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 empowered to ask new questions, make bolder decisions and take smarter risks. 

We are Novartis. Join us and help reimagine medicine.

Job ID Reference
Desired Skills & Experience

What you'll bring to the role: 

• A Bachelor's Degree or equivalent 4-year degree in Pharmacy, Biochemistry, Chemistry, Biology, Engineering or other related life science degree. An advanced degree is preferred. Fluent English (oral and written).

• 15 years of experience in the pharmaceutical industry with direct experience with Compliance and Quality Systems; 4 years of demonstrated success managing others; Aseptic experience preferred.

• Experience in drug development, clinical, manufacturing, outsourcing and/or other relevant operational areas, must include at least 8 years in Quality Assurance.

• Thorough knowledge GMP requirements and a strong understanding of regulatory requirements for Quality Systems. A proven track record with FDA, EMA, and other Health Authorities. Strong understanding of risk assessment and risk management fundamentals and tools.

• Team building and process harmonization skills.

  Morris Plains, NJ, USA
 Morris Plains, NJ, USA