Head, Quality Assurance Operations

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.
The Head, QA Operations role is responsible for the final release of product and overall end to end quality management of operational units at the manufacturing site which is considered the Center of Excellence for Cell and Gene. This role ensures that the quality strategy is implemented and that there is a continuous drive to improve product and process quality within the operational units.
Your responsibilities include, but are not limited to:

• Ensures consistency of quality standards and their implementation throughout the operations units for the site, including championing a culture valuing data integrity.
• Develop and strengthen the Quality Culture at the Site level ensuring GMP compliance and continuous quality management improvement by facilitating and promoting empowerment and accountability.
• Partners with other CGT production facilities to facilitate platform discussions and enhancements.
• Provides the review and quality decision of all batch related documentation (batch records, Labels, Leaflets, etc)
• Provides quality in-put into product- or process-related deviations, change control, audits/inspections. Ensures proper escalation and remediation of all critical issues. Participates in Site and Global Quality Assessment processes.
• 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.
• Responsible for the batch disposition for all patient lots manufactured at the site, ensuring every lot meets high standard of quality, safety, regulatory and client expectations.
• Provides QA resources “on the floor” in each of the areas to perform the QA function and provide real-time and direct review, approval, or feedback for the operations at the manufacturing site.
• Leads and develop the Operations Quality Team and key talent ensuring GMP compliance and continuous quality improvement in all operational aspects for the manufacturing site. Responsible for managing the QA Operations team which includes Batch Release and Value stream operations support.
• Ensure quality systems such as complaints, deviation management and change control are in place and consistent for the Center of Excellence and all products manufactured there.
• Act as a role model in accordance with the Novartis Values and Behaviors and the leadership standards.
• Ensures that critical materials used in the manufacture of products, are received and tested according to approved standards, and provides the disposition of these materials.
• Provides QA oversight of shipping and receipt of patient product as starting material or final product for the entire manufacturing site
• Verifies data integrity across the operations units in the manufacturing site.
• Drive and support the business demand of CGT QA Operational function in support of the production demand.
• Ensures the monitoring of process and product related KQIs and report to Site and Global Management. Ensure robust CAPA management for all unacceptable conditions at the site.
• Ensure consistency of quality related processes and procedures within the Operations Units for the manufacturing site and Center of Excellence.
• Ensures appropriate quality oversight, end to end, for the GMP site and COE for Production, QC, and facilities, and logistics activities.
• Ensures proper training and qualification of all Operational quality assurance associates in team.
• Act a sponsor for potential talents to develop the talent pipeline.
• Manage the implementation of Novartis Policies (Novartis Quality Manual) within the Operations Units to ensure quality processes are maintained and current to ensure compliance with regulatory standards
• Ensure preparation and delivery of relevant Validation Plans, Site Quality Risk Assessments, and Quality Assessments associated with the operations at the site.
• 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.
• Responsible for the budget in close cooperation with the Quality Head

This position will be located in Morris Plains, NJ and will not have the ability to be located remotely.

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

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.

What you’ll bring to the role:
Education: A minimum of a BA/BS degree is required in the Biotechnology, or Chemistry Life Science degree (Pharmacist, Chemist or equivalent scientific Education) Master degree is preferred.

• Must have an understanding of pharmaceutical industry trends and practices
• Related experience in supporting an operational quality assurance team
• Must have a strong working knowledge of regulatory (FDA, EMEA Etc.,,) requirements as well as industry quality management tools, standard, project management , and quality systems is
• Minimum of 5 years People Management experience
• Related experience should be in GMP-regulated industries in quality assurance and/or compliance or equivalent experience
• Minimum of 7 years experience in the pharmaceutical or relevant industry experience

Desirables:

• Familiar with Lab equipment Validation/Qualification Master Plan &Protocols is desired
• Knowledge and understanding of manufacturing, quality control, and validation requirements and activities during project, product launch scale out phase for a QA operational unit is desired
• Experience in leading site audits provides SME where necessary to support QA operational topics during audits is desired

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 teams representative of the patients and communities we serve.
Accessibility and Reasonable Accommodations: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or 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 $151,200 and $226,800 per year per year; however, while salary ranges are effective from 1/1/23 through 12/31/23, 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.

Operations

QUALITY

USA

Morris Plains, NJ

Novartis Pharmaceuticals

Quality

Full Time

Regular

No

No