Site Quality Head, Texas (AD level)

Band

Job Description Summary

Job Description

Key Responsibilities

• Lead site quality strategy and governance to meet Novartis standards and current Good Manufacturing Practice.
• Build coach and develop the Quality team strengthening capability engagement and safe working practices.
• Drive plant startup expansions and technology transfer ensuring compliant planning commissioning qualification and validation activities.
• Lead inspection readiness and represent the site during health authority corporate and internal audits.
• Oversee deviations investigations out-of-specification events and corrective and preventive actions through effective closure.
• Partner with Manufacturing and cross-functional leaders to enable compliant efficient operations and risk-based decision making.
• Define and monitor site quality performance indicators driving continuous improvement and timely escalation of risks.

Essential Requirements

• Bachelors degree in life sciences or a related scientific discipline.
• Ten years of experience in a GMP pharmaceutical manufacturing environment including laboratory operations and Aseptic experience and at least three years of combined relevant experience in Quality Assurance and/or Quality Control roles.
• In-depth knowledge of cGMP and United States Food and Drug Administration regulations and International Council for Harmonization regulations. Understanding of US Pharmacopeia European Pharmacopeia and American Chemical Society standards.
• Proven success leading health authority inspections and delivering robust remediation and sustained compliance improvements.
• Demonstrated leadership in matrix organizations with excellent communication organizational and stakeholder management skills.
• Experience applying continuous improvement methods such as Lean Six Sigma Total Quality Management and 5S workplace organization.

Desirable Requirements

• Prior experience with site start-up or rapid site expansion
• Experience or training in Radioligand Therapies radiopharmaceuticals and/or radiation safety.

The salary for this position is expected to range between $ 138600 and $257400 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 -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 addition employees are eligible for a generous time off package including vacation personal days holidays and other leaves.

To learn more about the culture rewards and benefits we offer our people click here.

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 gender national origin age sexual orientation gender identity or expression marital or veteran status disability or any other legally protected status. We strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

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 in order to perform the essential functions of a position please send an e-mail to call 1 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Range

Skills Desired