Site Quality Head, Morrisville (Director)
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. It is accountable for maintaining compliance with cGMP requirements, regulatory expectations, ISO standards, and Novartis Quality policies, and for providing leadership and oversight across site quality matters. The role will develop a high-performing Quality organization, foster a strong culture of quality and continuous improvement, and partner with site leadership to support strategic and operational priorities. The position serves as a key member of the Site Leadership Team and may act as Site Head delegate when required. Applicants must be authorized to work in the United States without current or future visa or immigration 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, with the ability to operate effectively across site and organizational stakeholders.
- Authorization to work in the United States without requiring 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, 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.
Benefits
- Performance-based cash incentive.
- Depending on the level of the role, eligibility to be considered for annual equity awards.
- Comprehensive benefits package for eligible US-based employees, including health, life, and disability benefits.
- 401(k) with company contribution and match.
- Generous time off package including vacation, personal days, holidays, and other leaves.
- A variety of other benefits.
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What This Job Offers
Job Type
Full-time
Career Level
Director
