Site Quality Head, Morrisville (Director)

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 site’s strategic and operational priorities.

#LI-Onsite

About the Role

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 $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.

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