Site Quality Head, Millburn

Job Description Summary

Job Description

Key responsibilities:

• Provide leadership, direction and support to the people within the Quality Assurance department and ensure that they are qualified, achieve a high level of competence, are motivated and carry out their duties in a safe manner.
• Timely escalation of risks in meeting timelines and / or budget incorporating site master planning and the long-term strategic plan.
• Provide leadership for strategic site initiatives and represent site SLT quality in local cross-functional and global projects teams as team member or team leader that represent site quality. Establish Quality as a valued business partner.
• Define, implement, monitor, consolidate and analyze Site Quality KPIs. Ensure Site Quality Committee is established, 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, DI Plan, Site Quality Risk Assessments and other relevant gap assessments.
• Ensure proper preparation and consolidation of the budget for the Quality Unit.
• 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 Health Authority notifications.

Essential Requirements:

• BS in Life Sciences and/or related experience in lieu of degree. 10 years of experience in GMP Pharmaceutical Manufacturing (including laboratory operations and Aseptic experience), at least 3 years combined of relevant experience in Quality Control and/or Quality Assurance.

• Proven track record and practical experience in supporting a Quality Control operations unit and operating in full compliance with global cGMP requirements. Successfully managed inspections from major Health Authorities (e.g. US FDA, EMA)

• In-depth knowledge of cGMP, FDA regulations (21 CFR Parts 211, 212), and ICH regulations. Understanding of United States Pharmacopoeia (USP), European Pharmacopoeia (EP), American Chemical Society (ACS).

• Proven ability to manage multiple projects with moderate resource requirements, risk and/or complexity. Highly developed management and communication skills, with experience in working in a matrix organization.

• Experience in process improvement approaches (Lean Six Sigma, Total Quality Management, 5S, etc.) Understands economic business impacts of decisions. Defining and implementing productivity improvement measures.

The salary for this position is expected to range between $168,000 and $312,000 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.

EEO Statement:

The Novartis Group of Companies are Equal Opportunity Employers. 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.

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

Skills Desired