388162BR
Apr 04, 2024
USA
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 Compliance Lead will provide regulatory compliance awareness, education, and guidance to the different functional areas on how to interpret, understand and comply with the regulation requirements and expectations including GMP and industry practices. In this role you will be responsible for overseeing and supporting the Inspection Audit Program, Customer Complaint Reporting, Supplier Qualification Program, Annual Product Quality Review, Health Authority Notifications & Market Actions, and Escalation Management.
Your responsibilities include, but are not limited to:
• Contributes to the design architecture of Quality Compliance by authoring or providing robust compliance feedback to the procedures governing the site compliance programs and working with other functional departments towards their timely implementation.
• Supports the site level Quality Management Review program including monitoring and reporting key performance indicators, as appropriate.
• Works with the management team to implement and execute the Inspection Readiness program, including Novartis Corporate Inspections and Global Health Authority Inspections.
• Supports quality inspections at the site level.
• Monitors industry observations and trends as a preventive tool to ensure compliance.
• Develops internal audit schedule and lead internal audit performance, follow up, and escalation of significant observations.
• Supports management to implement and maintain the following programs: Annual Product Quality Review (APQR), Compliance Alerts, Market Actions and Novartis Global document assessments
• Leads and prioritize on-going continuous improvement projects directly related to Quality Compliance to support business needs.
• Reviews and approve global change controls, deviations and CAPA and perform effectiveness checks.
• Acts as representative in monthly Quality Management Review meeting (QMR) to review plant metrics, ensure a state of control and drive action where appropriate along with reporting on a specific set of quality and compliance metrics.
The Quality Compliance Lead will provide regulatory compliance awareness, education, and guidance to the different functional areas on how to interpret, understand and comply with the regulation requirements and expectations including GMP and industry practices. In this role you will be responsible for overseeing and supporting the Inspection Audit Program, Customer Complaint Reporting, Supplier Qualification Program, Annual Product Quality Review, Health Authority Notifications & Market Actions, and Escalation Management.
Your responsibilities include, but are not limited to:
• Contributes to the design architecture of Quality Compliance by authoring or providing robust compliance feedback to the procedures governing the site compliance programs and working with other functional departments towards their timely implementation.
• Supports the site level Quality Management Review program including monitoring and reporting key performance indicators, as appropriate.
• Works with the management team to implement and execute the Inspection Readiness program, including Novartis Corporate Inspections and Global Health Authority Inspections.
• Supports quality inspections at the site level.
• Monitors industry observations and trends as a preventive tool to ensure compliance.
• Develops internal audit schedule and lead internal audit performance, follow up, and escalation of significant observations.
• Supports management to implement and maintain the following programs: Annual Product Quality Review (APQR), Compliance Alerts, Market Actions and Novartis Global document assessments
• Leads and prioritize on-going continuous improvement projects directly related to Quality Compliance to support business needs.
• Reviews and approve global change controls, deviations and CAPA and perform effectiveness checks.
• Acts as representative in monthly Quality Management Review meeting (QMR) to review plant metrics, ensure a state of control and drive action where appropriate along with reporting on a specific set of quality and compliance metrics.
Diversity & Inclusion / EEO
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:
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
• BS in Life Sciences or other relevant scientific field with minimum of 6 years' experience within a regulatory or pharmaceutical environment. Master's a plus.
• Comprehensive knowledge and understanding of FDA, ICH, EU, and Health Canada regulatory compliance requirements, guidelines, standards, and expectations.
• Direct experience reviewing and/or authoring global policies and standard operating procedures.
• Experience with system selection and/or global implementation of QMS
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 $112,800.00 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
• Comprehensive knowledge and understanding of FDA, ICH, EU, and Health Canada regulatory compliance requirements, guidelines, standards, and expectations.
• Direct experience reviewing and/or authoring global policies and standard operating procedures.
• Experience with system selection and/or global implementation of QMS
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 $112,800.00 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
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Operations
QUALITY
USA
Indianapolis, IN
AAA USA Inc.
Quality
Full Time
Regular
No
