Site Quality Head, Morrisville (Director)

Job Description Summary

Location: Morrisville North Carolina

Please note: Novartis is unable to provide visa or immigration support for this position. Applicants must have authorization to work in the United States without requiring current or future sponsorship.

As Site Quality Head you will lead the Quality organization for our new Small Molecule site in Morrisville North Carolina with a unique opportunity to build and guide the site Quality organization through ramp-up and commercialization. You will provide strategic leadership to ensure regulatory compliance product quality and operational excellence across manufacturing operations. You will be accountable for maintaining compliance with cGMP requirements regulatory expectations ISO standards and Novartis Quality policies while providing leadership and oversight across all site quality matters. You will develop a high-performing Quality organization foster a strong culture of quality and continuous improvement and partner with site leadership to support the sites strategic and operational priorities.

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Job Description

Key Responsibilities

Lead the independent site Quality organization providing strategic and operational Quality leadership as the new Small Molecule site progresses through ramp-up and commercialization.

Establish maintain and continuously improve the site Quality Management System (QMS) ensuring effective Quality governance and oversight across site operations.

Ensure compliance with cGMP regulatory requirements Novartis Quality Standards and applicable ISO requirements while driving site inspection readiness and Quality governance processes.

Ensure product quality and effective Quality Risk Management including appropriate management and escalation of quality issues and maintenance of data integrity and compliant quality records.

Provide GxP oversight across Manufacturing Quality Control distribution change management validation and qualification equipment utilities and facilities supplier quality stability programs eCompliance and data integrity.

Lead Health Authority interactions and regulatory inspections ensure timely responses to inspection observations maintain compliance with local and global regulatory requirements and appropriately escalate critical Quality issues.

Recruit develop and retain a high-performing Quality organization including coaching and developing managers and Quality professionals driving succession planning and talent development and fostering employee engagement and a strong Quality culture.

Serve as a key member of the Site Leadership Team promoting Safety and Quality culture supporting business continuity planning contributing to site strategy and operational excellence initiatives and acting as Site Head delegate when required.

Essential Requirements

University degree in Pharmacy Chemistry Biotechnology or a related scientific discipline.

10 years of pharmaceutical Quality and/or Manufacturing experience. Experience must include at least 5 years of recent experience with small molecules.

Strong Quality Assurance and Quality Control background with demonstrated knowledge of pharmaceutical quality and cGMP requirements.

Demonstrated experience leading regulatory inspections and interactions with Health Authorities.

Proven people leadership experience with multiple direct reports. Experience serving as a senior Quality leader within a site leadership team or similarly complex manufacturing environment is preferred.

Experience working within multinational pharmaceutical environments with the ability to operate effectively across site and organizational stakeholders.

Desirable Requirements

Experience advancing operational excellence and continuous improvement within a pharmaceutical Quality organization.

Experience supporting the ramp-up of new pharmaceutical manufacturing facilities.

The salary for this position is expected to range between $168000 and $312000 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 -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 addition employees are eligible for a generous time off package including vacation personal days holidays and other leaves.

To learn more about the culture rewards and benefits we offer our people click here.

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 or call 1 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Salary Range

$168000.00 - $312000.00

Skills Desired

Business Acumen Change Management Collaboration Communication Continuous Improvement Financial Acumen Leadership People Management Quality Assurance (QA) Quality Compliance Quality Management Quality Management Systems (QMS) Risk-Based Decision Making Risk Management Stakeholder Management Storytelling Strategic Thinking