Senior Quality Assurance Engineer Lead

Major accountabilities:

First phase: Greenfield project for the construction, qualification and validation of the lutetium isotope manufacturing site

• Acts as QA contact point and subject matter expert for the design, construction, commissioning, qualification and validation activities for manufacturing and QC areas

• Represents the quality function in cross-functional project teams and in commissioning activities such as FAT and SAT

• In collaboration with the Site’s Manufacturing Science and Technology department (MS&T) reviews and approves the establishment, review and approval of the expansion project qualification and validation master plans

• Acts as a subject matter expert and point of contact for the inclusion of Novartis and regulatory requirements into the commissioning, qualification and validation master plans and protocols

• Supports the creation and review of source documentation intended to be used for regulatory submission. Supports the preparation and execution of pre-approval inspection by FDA or any other health authority

Second phase: Commercial manufacturing

• Supports further expansion of the site with additional manufacturing lines including establishment, review and approval of maintenance and calibration strategy, validation and maintenance protocols, reports and records for the production, warehouse/supply chain and QC departments

• Acts as single point of contact for QA validation/calibration and maintenance during audits and inspections. Primary subject matter expert for GMP regulatory inspections, specifically for qualification. Performs QA oversight for validation and qualification activities for specific manufacturing and QC studies

• Acts as QA investigator to review deviations or OOx related to validation, maintenance, calibration, and technical production related issues. Ensures the root cause is determined, evaluates the impact on product quality and disposition of the batches. Defines corrective and preventive actions linked to the records in scope of the functions and ensures timely implementation

• Reviews and approves changes related to the facility, computerized systems and production/QC equipment. Supports the GAP assessments between the site’s practices/local procedures and Corporate procedures. Acts as main contact for the inclusion of new validation/maintenance/calibration/engineering Corporate/Global procedures in Novartis RLT Indianapolis isotope manufacturing ’s quality systems documentation system.

• Contributes to the generation of the Annual product review

Essential Requirements:

• Bachelor’s degree in a scientific area. Advanced degree preferred.

• 5 years of experience in validation, maintenance, engineering or technical quality in a pharmaceutical cGMP or medical device environment

• Knowledge of cGMP for the defined area

• Open and clear collaboration and communication skills

• Very good administrative skills and working knowledge of MS365 and Adobe Acrobat

The pay range for this position at commencement of employment is expected to be between $112,800   and $169,200 per year; however, while salary ranges are effective from 1/1/24 through 12/31/24 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.

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Commitment to Diversity and Inclusion: 
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