Site Quality Head, Morrisville (Director)

U473 (FCRS = US473) Novartis Innovative Technologies Inc; Morrisville (NC); Presencial; USD 168.000 - 312.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health benefits

401(k) with company match

Generous time off

Descripción de la vacante

Novartis Innovative Technologies Inc in Morrisville, North Carolina, is seeking a Site Quality Head to lead the Quality organization at the new Small Molecule site. The role guides ramp-up and commercialization, ensuring regulatory compliance, product quality and operational excellence across manufacturing operations.

You will establish a comprehensive QMS, drive inspection readiness, oversee Health Authority interactions, and develop a high-performing team while partnering with site leadership

Formación

• University degree in Pharmacy, Chemistry, Biotechnology, or a related scientific discipline.
• 10+ years of pharmaceutical Quality and/or Manufacturing experience with at least 5 years in small molecules.
• Strong QA and QC background with knowledge of cGMP requirements.
• Experience leading regulatory inspections and interactions with Health Authorities.

Responsabilidades

• Lead the independent site Quality organization, providing strategic and operational Quality leadership through ramp-up and commercialization.
• Establish, maintain, and continuously improve the site Quality Management System (QMS).
• Ensure compliance with cGMP, regulatory requirements, Novartis Quality Standards, and ISO requirements; drive inspection readiness and governance.
• Provide GxP oversight across Manufacturing, QC, distribution, validation, and supplier quality.
• Lead Health Authority interactions and regulatory inspections; manage inspection observations and escalations.
• Recruit, develop, and retain a high-performing Quality organization and foster a strong quality culture.
• Serve as Site Head delegate and member of Site Leadership Team, supporting safety and strategic priorities.

Conocimientos

Business Acumen

Change Management

Collaboration

Communication

Continuous Improvement

Financial Acumen

Leadership

People Management

Quality Assurance

Quality Compliance

Quality Management

Quality Management Systems

Risk-Based Decision Making

Risk Management

Stakeholder Management

Storytelling

Strategic Thinking

Educación

Pharmacy/Related scientific discipline

Descripción del empleo

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 site’s strategic and operational priorities.

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 escalating 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.

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

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.

Salary Range $168,000.00 - $312,000.00

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.

Improving the lives of people living with disease takes more than innovative science. It takes a focus on the needs of people and a community committed to meeting them. It takes a team of people like you. Working together. Learning together. Thriving together. Discover how you can join us in changing people’s lives.

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 [e-mail] or call [phone] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.