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Form of workAbout 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 Site Quality Head will provide quality assurance oversight and be accountable for supporting site start up and Quality operations at the US Millburn, NJ Site. Provide technical and strategic leadership for the Manufacturing site for all quality-related matters. Accountable to ensure compliance to GxP standards for Therapy Products, including product manufacturing and testing. Ensures Compliance with cGMP requirements and with the Novartis Quality Manual and policies.
Your responsibilities include, but are not limited to:
• Provide leadership, direction and support to the people within the Quality Assurance department and ensure that they are qualified, achieve a high level of competence, are motivated and carry out their duties in a safe manner.
• Timely escalation of risks in meeting timelines and / or budget incorporating site master planning and the long-term strategic plan.
• Ensure adequate management of product critical quality issues (deviations, out of specifications). Ensure investigations are correctly executed and adequate CAPAs are defined, and proper follow up of CAPAs effectiveness. Review, provide guidance for, escalate where appropriate, and approve HA notifications (compliance related such as Exception requests, other).
• Define, implement, monitor, consolidate and analyze Site Quality KPIs. Ensure Site Quality Committee is established, ensure relevant corrective and preventive actions are endorsed and implemented.
• Drive for Site management team accountability. Coordinate the generation and monitor the execution of the Site Quality Plans, DI Plan, Site Quality Risk Assessments and other relevant gap assessments.
• Ensures proper preparation and consolidation of the budget for the Quality Unit.
• Ensure health & safety procedures are followed
• Hiring people, team building, people development and talent retention.
• Establish Quality as a valued business partner.
Role Requirements
What you'll bring to the role:
Bachelor's degree in Life Sciences required.
• 10years of experience in GMP Pharmaceutical Manufacturing (including laboratory operations and Aseptic experience), at least 3 years combined of relevant experience in Quality Control and/or Quality Assurance covering quality areas.
• Proven track record and practical experience in supporting a Quality Control operations unit and operating in full compliance with global cGMP requirements. Successfully managed inspections from major Health Authorities (e.g. US FDA, EMA)
• In-depth knowledge of cGMP, FDA regulations (21 CFR Parts 211, 212), and ICH regulations.
• Understanding of United States Pharmacopoeia (USP), European Pharmacopoeia (EP), American Chemical Society (ACS)
• Proven ability to manage multiple projects with moderate resource requirements, risk and/or complexity
• Highly developed management and communication skills, with experience in working in a matrix organization.
• Strong organizational and time management skills.
• Quality oriented with attention to details.
• Highly proactive, self-motivated, professional, and dedicated.
• Experience in process improvement approaches (Lean Six Sigma, Total Quality Management, 5S, etc.)
• Understands economic business impacts of his/her decisions. Defining and implementing productivity improvement measures.
• Pragmatic approach with good scientific and quality thinking.
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 $183200. and $274800 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 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.
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 opportun
EEO Statement
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:
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 Site Quality Head will provide quality assurance oversight and be accountable for supporting site start up and Quality operations at the US Millburn, NJ Site. Provide technical and strategic leadership for the Manufacturing site for all quality-related matters. Accountable to ensure compliance to GxP standards for Therapy Products, including product manufacturing and testing. Ensures Compliance with cGMP requirements and with the Novartis Quality Manual and policies.
Your responsibilities include, but are not limited to:
• Provide leadership, direction and support to the people within the Quality Assurance department and ensure that they are qualified, achieve a high level of competence, are motivated and carry out their duties in a safe manner.
• Timely escalation of risks in meeting timelines and / or budget incorporating site master planning and the long-term strategic plan.
• Ensure adequate management of product critical quality issues (deviations, out of specifications). Ensure investigations are correctly executed and adequate CAPAs are defined, and proper follow up of CAPAs effectiveness. Review, provide guidance for, escalate where appropriate, and approve HA notifications (compliance related such as Exception requests, other).
• Define, implement, monitor, consolidate and analyze Site Quality KPIs. Ensure Site Quality Committee is established, ensure relevant corrective and preventive actions are endorsed and implemented.
• Drive for Site management team accountability. Coordinate the generation and monitor the execution of the Site Quality Plans, DI Plan, Site Quality Risk Assessments and other relevant gap assessments.
• Ensures proper preparation and consolidation of the budget for the Quality Unit.
• Ensure health & safety procedures are followed
• Hiring people, team building, people development and talent retention.
• Establish Quality as a valued business partner.
Role Requirements
What you'll bring to the role:
Bachelor's degree in Life Sciences required.
• 10years of experience in GMP Pharmaceutical Manufacturing (including laboratory operations and Aseptic experience), at least 3 years combined of relevant experience in Quality Control and/or Quality Assurance covering quality areas.
• Proven track record and practical experience in supporting a Quality Control operations unit and operating in full compliance with global cGMP requirements. Successfully managed inspections from major Health Authorities (e.g. US FDA, EMA)
• In-depth knowledge of cGMP, FDA regulations (21 CFR Parts 211, 212), and ICH regulations.
• Understanding of United States Pharmacopoeia (USP), European Pharmacopoeia (EP), American Chemical Society (ACS)
• Proven ability to manage multiple projects with moderate resource requirements, risk and/or complexity
• Highly developed management and communication skills, with experience in working in a matrix organization.
• Strong organizational and time management skills.
• Quality oriented with attention to details.
• Highly proactive, self-motivated, professional, and dedicated.
• Experience in process improvement approaches (Lean Six Sigma, Total Quality Management, 5S, etc.)
• Understands economic business impacts of his/her decisions. Defining and implementing productivity improvement measures.
• Pragmatic approach with good scientific and quality thinking.
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 $183200. and $274800 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 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.
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 opportun
EEO Statement
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 us.reasonableaccommodations@novartis.com or call +1 (877)395-2339
- Sandoz: e-mail reasonable.accommodations@sandoz.com or call: +1-609-422-4098
