Head of Compliance and QMS (Quality Management Systems)
Job Description 365 days a year, we aspire to be the best manufacturer of Cell & Gene therapies to ensure our patients have the treatments they need to live longer, healthier lives.
Purpose:
Ensure compliance to GxP standards for Cell and Gene Therapy Products, including product manufacturing. Proactively drives establishment of compliance culture through implementation of harmonized standards, monitoring and reporting status. Manage projects and/or processes and allocated resources to support departmental projects and objectives according to agreed timelines and standards
Ensure CGT networks operate in alignment with Novartis QMs/QDs and BTDM GOPs. Act as the point of contact in CGT for Global QMS to ensure alignment and successful QM/QD/GOP implementation
Ensure adequate roll out and tracking of the DI initiates within the CGT organization in alignment with the CGT Data Integrity Lead
Major Accountabilities
* Act as Deputy to the site Quality Head on all aspects of site quality inclusive of signing/approving GMP and other documents on behalf of the Quality Head as needed.
* Lead a group of associates (5+) and manage resources allocation to ensure timelines and key milestones are met
* Lead the development of the Quality Management Systems for Cell and Gene Therapy at Novartis, ensuring that the Systems including policies, standards, processes and governance developed are "fit for purpose" to provide a robust framework from the development to future commercialization of safe and efficacious products which comply with Novartis GMP/GDP Quality Standards, emerging regulatory standards and global GMP/GDP guidance.
* Evaluate impact and anticipate implication of important emerging regulatory requirements in collaboration with QA and Regulatory business partners Integrate the external expectations into the Novartis Standards for Cell and Gene Therapies through adapting existing or writing new Standards, Directives, or QMs. Collaboration through effective relationships and partnership with External Relations for the ongoing monitoring of emerging regulations
* Establish and execute the Quality Management Systems strategy for CGT including standards, processes and governance required to encompass all aspects of GMP, GDP, and determine the appropriate interfaces and seamless continuity with GLP and GCP requirements
* Manage the integration of CGT QMS into global Novartis QMS
* Provide QS oversight for Data Integrity Program for the CGTU. Ensuring that NVS and Pharma DI requirements and expectations are embedded into CGTU processes and programs
* Facilitate and manage the Quality Review Board (Management Review) for the CGTU
* Manage the implementation and maintenance of Training system to ensure personnel are adequately trained
* Manage complaints, recalls, returns, according to the Novartis corporate quality manual and support / participate in NEM cases as required
* Develop and implement the strategies, processes and plans for the inspection readiness and response planning, in line with the policies established by Group Quality and Pharma Quality Compliance and Auditing
* Develop and strengthen the Quality Culture within the Quality Unit and at Site level ensuring GMP compliance and continuous quality management improvement by facilitating and promoting empowerment and accountability
* Ensure adequate management of product critical quality issues (deviations, out of specifications). Ensure investigations are correctly executed and adequate CAPAs are defined, and proper follow up of CAPAs effectiveness. Review, provide guidance for, escalate where appropriate, and approve HA notifications (compliance related such as BPDRs recalls, other).
* Governance process: Lead the Quality Governance Board for site. Communicate GxP related compliance issues, provide on-going status reports, and provide clear and actionable reports to the Management Team on KPIs, Issues, trends and results of benchmarking efforts.
* Leads or participates in Quality projects
* Define, implement, monitor, consolidate and analyze Site Quality KPIs. Prepare and lead Site Quality Committee, ensure relevant corrective and preventive actions are endorsed and implemented. Drive for Site management team accountability. Coordinate the generation and monitor the execution of the Site Quality Plans, Site Quality Risk Assessments and other relevant gap assessments
* Monitors the compliance to file status through initial filing data verification and on-going registration compliance checks: Facilitates gap assessment and oversees re-mediation activities.
* Collect, analyze and report result of compliance surveys (such as data integrity) and provide summary reports and status to key stakeholders.
* Participate to the preparation and consolidation of the budget of the Quality Unit
* Ensure health & safety procedures are followed
https://www.youtube-nocookie.com/embed/ggbnzRY9z8w EEO Statement 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 will bring to the role:
Education:
-Degree in Natural Sciences or related experience
Experience:
-5+ years' experience in an operational GxP area, in Manufacturing/Development or QA
-Knowledge in chemistry, pharmacy, biotechnology, or Cell & Gene Therapy preferred
-Experience in Compliance a plus!
Highly Desirable:
Cell & Gene Therapy experience
Audit Management
People Leadership
Knowledge of QMS system
Why Novartis?
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!
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team's representative of the patients and communities we serve.
Accessibility and reasonable accommodation
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 tas.nacomms@novartis.com 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.
The pay range for this position at commencement of employment is expected to be between $144,000 and $216,000/year; however, while salary ranges are effective from 1/1/22 through 12/31/22, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network Division Novartis Technical Operations Work Location Morris Plains, NJ Company/Legal Entity Novartis Pharmaceuticals
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Novartis Group Companies
December 07, 2022