QA Compliance Specialist

Band

Level 3

Job Description Summary

Location: Indianapolis United States

Play a pivotal role in ensuring the highest standards of quality and compliance in a cutting-edge radioligand therapy environment. As a QA Compliance Specialist you will help shape and sustain robust quality systems that enable safe reliable and inspection-ready operations. Partnering across site functions youll drive compliance excellence support regulatory readiness and contribute to continuous improvementmaking a direct impact on delivering innovative therapies to patients.

Relocation Support: This role is based in Indianapolis United States. Novartis is unable to offer relocation support: please only apply if accessible.

Job Description

Key Responsibilities

• Support implementation and oversight of site quality systems aligned with regulatory and Novartis standards
• Lead Quality Management Review activities including KPI monitoring reporting and continuous improvement actions
• Drive inspection readiness programs for internal audits and global health authority inspections
• Facilitate and deliver training on quality assurance compliance programs and requirements
• Support execution of compliance programs including training product quality reviews and compliance alerts
• Provide guidance on audit planning preparation and interactions with regulatory authorities
• Partner cross-functionally to ensure adherence to good manufacturing practices data integrity and compliance standards

Essential Requirements

• Bachelors degree in a scientific or health-related field and at least 5 years of experience in a GMP regulated environment including at least 3 years of experience in quality compliance in the biopharmaceutical industry with environmental monitoring and cleanliness zones.
• Experience in establishing and maintaining quality systems as well as successfully managing inspections from major Health Authorities including USA EMEA Canada Japan Brazil
• Previous Quality Assurance experience must include Data Integrity (ALCOA) compliance and technical writing.
• Strong knowledge of global regulatory standards including United States European Union and International Council for Harmonization requirements
• Strong communication and organizational skills with ability to manage complex compliance activities across teams

Desirable Requirements

• Experience supporting radioligand or radiopharmaceutical manufacturing operations and associated quality requirements

The salary for this position is expected to range between $89600 and $166400 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 -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.

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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

$89600.00 - $166400.00

Skills Desired

Collaboration Communication Skills (Inactive) Data Integrity Digital saviness (Inactive) Leadership Managing Ambiguity Problem Solving Skills (Inactive) Regulatory Requirements knowledge (Inactive)