Site Quality Head, Morrisville (Director)

Novartis•Morrisville, NC

2d•Onsite

About The Position

The Site Quality Head will lead the 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. The Site Quality Head is accountable for compliance with cGMP requirements, regulatory expectations, ISO standards, and Novartis Quality policies, and provides leadership and oversight across site quality matters. The position develops a high-performing Quality organization, fosters a strong culture of quality and continuous improvement, and partners with site leadership to support strategic and operational priorities. The position is onsite. Novartis cannot provide visa or immigration support; applicants must be authorized to work in the United States without current or future sponsorship.

Requirements

University degree in Pharmacy, Chemistry, Biotechnology, or a related scientific discipline.
10+ years of pharmaceutical Quality and/or Manufacturing experience, including 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 working within multinational pharmaceutical environments and ability to operate effectively across site and organizational stakeholders.
Authorization 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 and provide 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; drive 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; 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.