Job Description Summary

At Advanced Accelerator Applications, a Novartis company, we are committed to leading innovation in nuclear medicine and delivering the next generation of targeted radioligand therapy (RLT) to cancer patients. We are looking for an experienced pharmaceutical industry professional with validation, maintenance, engineering or quality experience to join the team at our new Lutetium isotope manufacturing site in Indianapolis.

As the Senior Quality Assurance Engineer Lead, your main focus will be providing support to the QA Operations organization for the review and approval of technical QA records. Initially the focus will be support for the design, construction, commissioning, qualification and validation of the new facility. Once the site has been qualified and approved, you will act as the main contact for technical QA related support for the site including acting as SME for change controls, reviewing technical QA documents, supporting deviation investigations and CAPA's from a quality perspective, etc. In this second phase, you will also be a key player for future site expansions.

Job Description

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.

Benefits and rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: Thrive Together (novartis.com).

Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

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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 tas.nacomms@novartis.com call +1 (877)395-2339 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

$112,800.00 - $169,200.00

Skills Desired

Continuous 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