Novartis Hiring for Quality Systems Senior Lead job in Indianapolis Full Time

About the role
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 to cancer patients. We are looking for experienced Quality professionals to help us reach our ambitious goals.

The Quality System Senior Lead is responsible for overseeing and supporting the site Quality Management Systems which include but are not limited to: Deviation Reporting, CAPA Program, Change Control Management, Training Program, and Document Control Management.

Responsibilities include but not limited to:

• Contributes, significantly, to the architecture of QMS, will author or contribute to the procedures governing these systems and will work towards timely implementation, providing expertise and participating fully in the management of health authority inspections.
• Provides quality input on the design and architecture of Quality Systems.
• Responsible for contributing to the development of robust quality systems, including both implementation and operation.
• Participates in global projects to optimize QMS workflow.
• Act as liaison between functional areas to ensure compliance and harmonization for QMS deployment.
• Reviews and approves global change controls, deviations, CAPAs and performs effectiveness checks.
• Ensures the effectiveness of the Quality Systems by developing and implementing effective processes and tools for assessing and controlling risks that potentially impact patient safety, product quality, and product supply.
• Assists functional area representative with training and QMS related issues and attend at monthly meetings in support of QMS implementation.
• Leads the site Quality Management Review (QMRs) meeting to review plant metrics, ensure as state of control and drive actions where appropriate along with reporting on a specific set of quality metrics.
• Develops, track, trend, and report QMS key performance indicators (KPI) to ensure continuous quality improvements.

Commitment to Diversity & Inclusion:
We 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: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please let us know the nature of your request, your contact information and the job requisition number in your message:

• Novartis: e-mail [email protected] or call +1 (877)395-2339
• Sandoz: e-mail [email protected] or call: +1-609-422-4098

Role Requirements
What you bring to the role:

• Bachelor of Science in Biology or other relevant scientific field with 8+ years of experience within a regulatory or pharmaceutical environment. Scientific or Regulatory graduate degree a plus
• Comprehensive knowledge and understanding of FDA, ICH, EU, and Health Canada regulatory compliance requirements, guidelines, standards, and expectations.
• Experience with Quality Management Systems (QMS)
• Demonstrated leadership experience that includes the ability to inspire, foster teamwork, and champion change as well as quality decision making.

Why Novartis: Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here:
https://www.novartis.com/about/strategy/people-and-culture

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 1/1/23 through 12/31/23 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.

You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook: https://www.novartis.com/careers/benefits-rewards

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 [email protected] 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.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network