Job Description Summary

Location: Morris Plains, NJ #LI-Onsite

About this role:
The department Facilitator plays a critical role in driving continuous improvement, ensuring compliance with industry standards, and enabling teams to achieve high-quality operational outcomes. Collaborating closely with production/quality, facilities and engineering, and management, they proactively identify and address issues while implementing best practices.

Additionally, the facilitator provides leadership and strategic guidance to the PU/QC teams, ensuring the effective execution of the operational plan in compliance with regulatory requirements (Health Authorities, SOX, OSHA, etc). This includes optimizing efficiency and cost-effectiveness by focusing on process improvements through OPEX initiatives, ramp-up activities, change control management, and document updates.

Job Description

Key Responsibilities:

Continuous Improvement & Operational Excellence: Lead and manage continuous improvement initiatives and Operational Excellence (OPEX) projects to optimize processes, reduce waste, and enhance operational efficiency. Leverage Lean and Six Sigma methodologies, along with project management techniques, to drive cost-effective improvements and reduce controllable expenses within the department.
Ramp-Up Support: Provide critical support during production ramp-up phases, ensuring smooth transitions and scaling of processes to meet operational demands, while maintaining quality and efficiency.
Change Control Management: Assist in overseeing change control processes, ensuring all modifications are thoroughly documented, reviewed, and approved in full compliance with regulatory and quality standards.
Documentation Accuracy: Maintain and update department-specific documentation, ensuring all records meet internal and external regulatory standards and are up to date and accurate.
Cross-Functional Collaboration: Collaborate closely with the Production Unit (PU) and Quality Control (QC) leadership teams to support and execute initiatives, ensuring alignment with overall business objectives.
Strategic Planning: Translate organizational goals into actionable strategic plans, enabling the PU/QC teams to effectively plan and execute future activities to meet or exceed targets.
Performance Delivery: Drive continuous improvement in quality, productivity, and cost-effectiveness to ensure the organization remains compliant and competitive in the marketplace.
Team Communication & Engagement: Foster a high-performance, collaborative team environment. Ensure that team members are regularly informed and aligned through effective communication, including team meetings and other updates.
Leadership Support: Act as a trusted partner to area leaders by supporting various leadership activities, including delegation of authority when needed, ensuring smooth and efficient operations.
Quality Culture: Champion a culture of quality throughout the organization, ensuring all team members understand and prioritize adherence to quality standards and regulatory requirements.

Essential Requirements:

Bachelor's degree, advanced degree or specialization certifications is preferred.
Minimum of 5 years' experience in the pharmaceutical/Biotechnology industries with Quality Assurance, Operations, and Management Experience.
Direct experience in applying quality assurance methodologies and ensuring product and process integrity, with attention to detail in defect identification and resolution.
Proven ability to lead and manage projects, from inception to completion, using modern project management methodologies (Agile, Lean, Six Sigma, etc.) and tools like MS Project or similar.
Strong analytical skills with the ability to identify root causes and implement effective solutions using structured methodologies.

Commitment to Diversity and Inclusion:

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

EEO Statement:

The Novartis Group of Companies are Equal Opportunity Employers who are focused on building and advancing a culture of inclusion that values and celebrates individual differences, uniqueness, backgrounds and perspectives. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to fostering a diverse and inclusive workplace that reflects the world around us and connects us to the patients, customers and communities we serve.

Accessibility and reasonable accommodations

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 to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com 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.

Salary Range

$112,800.00 - $169,200.00

Skills Desired

Assembly Language, Change Control, Chemical Engineering, Chemistry, Continual Improvement Process, Efficiency, General Hse Knowledge , Good Documentation Practice, Knowledge Of Capa, Knowledge Of Gmp, Lean Manufacturing, Manufacturing Process, Manufacturing Production, Process Control, Productivity, Risk Management, Root Cause Analysis (RCA), Scheduler, Six Sigma, Sop (Standard Operating Procedure), Team Work, Technology Transfer, Web Methods Flow