Site Quality Head, Morrisville (Director)

Novartis•Morrisville, VT

4d•$168,000 - $312,000•Onsite

About The Position

The Site Quality Head will lead the independent Quality organization for Novartis’s new Small Molecule site in Morrisville, North Carolina, guiding the organization through ramp-up and commercialization. The role provides strategic leadership to ensure regulatory compliance, product quality, and operational excellence across manufacturing operations, maintaining compliance with cGMP requirements, regulatory expectations, ISO standards, and Novartis Quality policies. The position is accountable for site-wide Quality matters, including establishing and continuously improving the Quality Management System, ensuring inspection readiness, and providing GxP oversight across site functions. The Site Quality Head will build and develop a high-performing Quality organization, foster a strong culture of quality and continuous improvement, and partner with site leadership on strategic and operational priorities.

Requirements

University degree in Pharmacy, Chemistry, Biotechnology, or a related scientific discipline.
10 or more years of pharmaceutical Quality and/or Manufacturing experience, including at least 5 years of recent small-molecule experience.
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 working in multinational pharmaceutical environments and ability to operate effectively across site and organizational stakeholders.
Applicants must be authorized to work in the United States without current or future visa or immigration sponsorship.

Nice To Haves

Experience serving as a senior Quality leader within a site leadership team or similarly complex manufacturing environment.
Experience advancing operational excellence and continuous improvement within a pharmaceutical Quality organization.
Experience supporting the ramp-up of new pharmaceutical manufacturing facilities.

Responsibilities

Lead the independent site Quality organization through site ramp-up and commercialization, providing strategic and operational Quality leadership.
Establish, maintain, and continuously improve the site Quality Management System and ensure effective Quality governance and oversight across site operations.
Ensure compliance with cGMP, regulatory requirements, Novartis Quality Standards, and applicable ISO requirements; drive inspection readiness and Quality governance processes.
Ensure product quality and effective Quality Risk Management, including managing and escalating quality issues and maintaining 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 escalate critical Quality issues appropriately.
Recruit, develop, and retain a high-performing Quality organization; coach and develop managers and Quality professionals; drive succession planning and talent development; and foster employee engagement and a strong Quality culture.
Serve as a key member of the Site Leadership Team, promote Safety and Quality culture, support business continuity planning, contribute to site strategy and operational excellence initiatives, and act as Site Head delegate when required.