Site Quality Head, Indianapolis

Band

Job Description Summary

Job Description

Key Responsibilities:

• Lead strategic Quality initiatives and represent the site Quality organization in global and crossfunctional projects.
• Provide direction coaching and development for the Quality team ensuring competence and engagement.
• Oversee compliance for equipment processes and facilities during design installation and validation phases. Support plant expansions and product transfers.
• Drive innovation and challenge stakeholders to implement new technologies and best practices.
• Manage critical Quality issues; ensure timely investigations corrective and preventive actions and regulatory notifications.
• Define and monitor site Quality key performance indicators risk assessments and corrective actions for continuous improvement.
• Represent the Quality Unit at global level contributing to multisite initiatives and business cases.
• Ensure effective budget planning and resource allocation for the Quality Unit.

Essential Requirements:

• Bachelors Degree in Life Sciences or equivalent relevant experience.
• 10 years of experience in GMP (Good Manufacturing Practice) pharmaceutical manufacturing including laboratory operations and aseptic experience; at least 3 years combined relevant experience in Quality Assurance and Quality Control.
• Proven track record supporting Quality Control operations and managing inspections by major Health Authorities such as the United States Food and Drug Administration and the European Medicines Agency.
• Indepth knowledge of cGMP FDA regulations (21 CFR Parts 211 and 212) International Council for Harmonization (ICH) guidelines and global quality standards.
• Familiarity with United States Pharmacopeia (USP) European Pharmacopoeia (EP) and American Chemical Society (ACS) standards for pharmaceutical compliance.
• Demonstrated ability to manage multiple complex projects with moderate resource requirements and risk.
• Strong leadership organizational and communication skills; experience working in a matrix environment.
• Expertise in process improvement methodologies (Lean Six Sigma Total Quality Management and the 5S workplaceorganization methodology) and understanding of the business impact of decisions.

The salary for this position is expected to range between $168000 and $312000 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 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 Thrive Together.

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