Lead, QA Operations

Band

Level 4

Job Description Summary

The role is responsible for the quality oversight of Production and Quality Control testing at Indianapolis Isotopes including final disposition of product. This role ensures that the quality strategy is implemented and that there is a continuous drive to improve product and process quality within the Production Unit. The role is responsible of supporting the site construction qualification validation and operational readiness from an operational quality perspective.

Location: Indianapolis #LI- Onsite
Position will initially be an AM shift however the work schedule will be defined through site start up and commercialization readiness.

Job Description

Key Responsibilities:

• QA oversight of technical activities related to commissioning qualification and process validation (Current ongoing expansion) As the project progresses this role will transition to providing leadership daily support and oversight of GMP operations.
• Support the development of the overall site operational readiness plan including implementation of Quality Systems and Processes to ensure product quality adherence to GMP and compliance with Novartis standards.
• Support initial recruiting and build capability for a quality assurance staff to support qualification validation and routine production.
• Responsible for quality oversight on overall laboratory readiness activities including equipment qualification test method validation/co-validation/transfer test method qualification/verification.
• Lead cross functional groups and build collaborative interfaces with stakeholders to ensure quality systems such as deviation management investigations corrective and preventive actions change control and complaint management are in place and followed.
• Support Isotopes/API FDA/Regulatory interactions for the Indianapolis site activities and products to ensure successful regulatory submissions and any commercial field actions.
• Ensure preparation and delivery of relevant Validation Plans.
• Act as Responsible Person for the final disposition and release of products. Ensure timely and compliant final product disposition of the Product.
• Ensures that deviations OOx CAPAs or any other record is reviewed and approved in a timely manner
• Ensure the coaching and training of the quality team and other site functions associates.
• Actively support audits/inspection management as well as the setup/maintenance of inspection readiness program.
• QA and/or QC experience in pharmaceutical industry with environmental monitoring & cleanliness zones

Essential Requirements

• Minimum of a bachelors degree or higher in Pharmacy Biochemistry Chemistry Biology Engineering or other related life science degree.
• 7 years experience in the pharmaceutical industry with direct experience with Compliance Quality Systems and sterile manufacturing.
• Previous Managerial experience in Quality Assurance
• Experience in Starting materials and API clinical manufacturing outsourcing and/or other relevant operational areas which must include Quality Assurance
• Thorough knowledge of GMP requirements
• Strong understanding of regulatory Quality Systems requirements
• Proven track record with FDA EMEA and other Health Authorities
• Strong understanding of risk assessment and risk management fundamentals/tools
• Team building and process harmonization skills.
• Proven leadership skills to drive quality improvement and guide changes.

Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $93800 and $174200/year; however while salary ranges are effective from 1/1/25 through 12/31/25 fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further final pay determinations will depend on various factors including but not limited to geographical location experience level knowledge skills and abilities. The total compensation package for this position may also include other elements including a sign-on bonus restricted stock units and discretionary awards in addition to a full range of medical financial and/or other benefits (including 401(k) eligibility and various paid time off benefits such as vacation sick time and parental leave) dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired employee will be in an at-will position and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time including for reasons related to individual performance Company or individual department/team performance and market factors.

EEO Statement:

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. 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 are committed to building diverse teams representative of the patients and communities we serve and 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

$93800.00 - $174200.00

Skills Desired

Continued Learning Dealing With Ambiguity Employee Performance Evaluations Gmp Procedures People Management Qa (Quality Assurance) Quality Control (Qc) Testing Quality Standards Self-Awareness Technological Expertise Technological Intelligence