Incoming Quality Supervisor

U469 (FCRS = US469) AAA USA Inc.; Indianapolis (IN); On-site; USD 90,000 - 166,000; Full time

Benefits offered by this job

Health, life and disability benefits

401(k) with company contribution and a

Generous time off (vacation, personal,

Job summary

Novartis in Indianapolis seeks an Incoming Quality Supervisor to lead QA for incoming materials, ensuring timely release for GMP drug product and radioligand therapy operations. You will manage a team, drive testing schedules, and uphold regulatory readiness.

You will collaborate with cross-functional teams, lead investigations and CAPA efforts, and contribute to continuous improvement in a high-visibility role.

Qualifications

• Bachelor degree in related science or engineering with 5+ years quality control experience.
• Experience in aseptic pharmaceutical manufacturing.
• Leadership potential to guide teams in a collaborative environment.
• Strong GMP knowledge and material sampling/analytical expertise.

Responsibilities

• Lead incoming quality inspection for Drug Product and Isotopes manufacturing.
• Provide daily leadership, coaching, and development for Raw Material and IQI teams.
• Schedule and oversee testing of all incoming raw materials for GMP release.
• Review GMP documentation and SOPs for material disposition.
• Lead investigations and root cause analyses related to materials testing.
• Interface with third-party labs to support testing schedules and release timelines.
• Serve as quality SME during regulatory inspections and audits.

Skills

Analytical Testing

Collaboration

Communication

Data Integrity

Decision Making

GMP

Managing Ambiguity

Quality Assurance

Quality Compliance

Quality Control

Quality Management Systems

Regulatory Compliance

SOP

SPC

Validation Activities

Education

Bachelor of Science in Chemistry/Biology/Pharmacy/Engineering

Job description

Band Level 3 Job Description Summary #LI-Onsite Location: Indianapolis, Indiana Relocation Support: This role is based in Indianapolis, Indiana. Novartis is unable to offer relocation support: please only apply if accessible.

Ready to expand your impact across multiple manufacturing operations? As the Incoming Quality Supervisor, you will provide quality oversight and leadership for incoming material inspection and release activities supporting both the Radioligand Therapy Drug Product and Isotopes manufacturing sites in Indianapolis. In this highly visible role, you will lead a team of quality professionals, ensure the timely availability of materials for Good Manufacturing Practice operations, drive continuous improvement initiatives, and support regulatory inspection readiness. This is an excellent opportunity for an internal associate to broaden leadership experience, strengthen cross-functional partnerships, and play a key role in delivering high-quality therapies to patients.

Job Description Key Responsibilities

• Lead incoming quality inspection activities to support Drug Product and Isotopes manufacturing operations.
• Provide daily leadership, coaching, and development for the Raw Material and Incoming Quality Inspection teams.
• Schedule and oversee testing of all incoming raw materials used in GMP manufacturing, including consumables and primary packing materials, to ensure timely release for manufacturing.
• Review and approve GMP documentation associated with materials control, and review, approve and revise standard operating procedures pertaining to the disposition of raw materials.
• Lead investigations, root cause analyses, and corrective actions related to raw martials testing.
• Interface with third party laboratories to support testing schedules and material release timelines.
• Serve as a quality subject matter expert during regulatory inspections and audits.

Essential Requirements

• Bachelor of Science degree in Chemistry, Biology, Pharmacy, Biochemistry, Engineering, or related experience.
• Minimum five years of quality control experience, including experience in an aseptic pharmaceutical manufacturing environment.
• 0-1 years of Leadership experience
• Strong knowledge of material sampling, analytical techniques, manufacturing operations, GMP requirements, and the principles behind them.
• Direct experience with investigations and root cause analysis in pharmaceutical or medical device environments.
• Demonstrated ability to lead, coach, and develop teams in a collaborative environment.

Desirable Requirements

• Experience supporting advanced therapies, including Radioligand Therapy manufacturing environments.
• Experience successfully leading Health Authority Audits and Inspections, including, front and/or back room, readiness, strategy and response to findings and observations.
• Knowledge of process improvement methodologies such as Lean, Six Sigma, or Five S principles.

The salary for this position is expected to range between $89,600 and $166,400 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.

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

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 [e-mail] call [phone] and let us know the nature of your request and your contact information. Please include the job requisition number in your message. https://www.novartis.com/careers/careers-research/notice-all-applicants-us-job-openings

Salary Range

$89,600.00 - $166,400.00

Skills Desired

• Analytical Testing
• Collaboration
• Communication
• Data Integrity
• Decision Making
• Good Manufacturing Practices (GMP)
• Managing Ambiguity
• Quality Assurance (QA)
• Quality Compliance
• Quality Control (QC)
• Quality Management Systems (QMS)
• Regulatory Compliance
• Standard Operating Procedure (SOP)
• Statistical Process Control (SPC)
• Validation Activities

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.

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