Senior QA Compliance Specialist

Sep 27, 2021

Job Description

769 million. That’s how many lives are touched by Novartis products globally. And, while we’re proud of that fact, in this world of digital and technological transformation, we must ask ourselves this: how can we continue to improve and extend even more people’s lives?

The Senior QA Compliance Specialist is responsible for compliance oversight of manufacturing, testing and supply chain operations with current GMP regulations, procedures, and quality systems.

Your responsibilities include, but are not limited to:

• Work closely with the production, quality control and supply chain departments to ensure their practice fully adheres to cGMP, including data integrity & eCompliance.
• Lead and support commercial product FDA/Regulatory interactions for the Indianapolis site activities and products to ensure successful regulatory submissions and audits.
• Provide guidance to the site functions on audit planning, preparation and interactions.
• Develop, maintain and propose continuous improvement of quality systems such as deviation management, investigations, corrective and preventive actions, change control, complaint management, procedures and training. Ensure these systems are in place and followed efficiently and compliantly. Act as system owner for Quality electronic systems.
• Own and manage the escalation process including timely coordination of communications, meetings, documentation and action follow up. Support related communications to Health Authorities when necessary.
• Coordinate and perform KPI reporting, APR/PQR reports and customer/third party complaints.
• Support oversight and perform supplier qualification processes including onboarding, assessments, auditing an• Provide support to peers within the QA Operations team.
• Provide support to peers within the QA Operations team.
• Support QA Operations as a valued business partner, with a culture of safety, quality, delivery to patients, cost, compliance, and data integrity.

Diversity & Inclusion / EEO

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.

Minimum Requirements

What you'll bring to the role:

Bachelor’s Degree in a scientific or health related field
5+ years of experience in a GMP environment
3+ years of experience in a GMP compliance environment

• Experience directly interacting with the FDA; experience with other Health Authorities a plus
• QA and QC experience in cGMP pharmaceutical industry; Environmental monitoring & cleanliness zones experience a plus
• Practical experience in establishing and maintaining quality systems
• Excellent IT and communication skills

Why Advanced Accelerator Applications (AAA)?

Thousands of people die of cancer around the world every day. At Advanced Accelerator Applications (AAA), a Novartis company, our mission is to transform lives through radioligand therapy in nuclear medicine to fight several leading types of cancer. How will we continue to be on the cutting edge of medicine?
We believe new groundbreaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity, and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!

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

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here:
Indianapolis, IN
Full Time
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Senior QA Compliance Specialist

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