Address
Form of workAbout the role
Location: Onsite - Millburn, NJ.
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 Compliance professionals to help us reach our ambitious goals.
As a Sr. QA Compliance Specialist, you are responsible for supporting all functions and activities within scope of the QA Compliance department. This role is accountable for the oversight and implementation of the change control system at the site, including RegCMC input and delivery for regulatory-relevant changes.
Key Responsibilities:
•Serve as primary liaison with Global and Country Quality/Regulatory teams (i.e., CMC and Labeling) for assessing the regulatory relevance, submission strategies, and source documents required for Change Controls owned by the site.
•Evolve Change Control practices and be an innovator of compliance best practices across the RLT platform.
•Maintain knowledge of the global regulatory dossiers for the site's products and facilitate the site's contributions, review, or edits to such documents in support of regulatory filings.
•Enhance site understanding of relevant regulatory issues and topics through training and collaboration on projects; coach and support Change Owners as necessary.
•Routinely monitor and report to site leadership key metrics regarding site compliance in executing Change Controls.
•Work closely with the Data Integrity (DI) officer and site departments to ensure site adherence to cGMP and regulatory filings, as applicable.
•Ensure compliance with the legal requirements of the applicable Health Authorities (GMP Certificates, Import Certificates, Export Certificates, Manufacturing Authorizations, etc.).
•Support Global Compliance initiatives, departmental projects and objectives according to agreed timelines and standards in the given area of competency and support adherence to compliance with GMP.
•Influence a culture of compliance and lead innovative compliance initiatives/projects across the site.
•Mentor other QA Compliance personnel or contractors as needed.
Additional Notes:
•This role is Monday-Friday, 1st shift on-site at our Millburn, NJ location.
Role Requirements
•Bachelor's degree preferably in a STEM (Science, Technology, Engineering & Math) field or related relevant degree.
•7+ years' experience in Quality Assurance/QA Compliance within the pharmaceutical and cGMP regulated industry required.
•Demonstrated ability with leading, executing, and documenting both complex change controls and regulatory strategies (e.g. launches, divestments, PAS, and CBE filings (US) as well as foreign equivalents).
•Demonstrated ability to create and cultivate strong relationships across site departments as well as other site & global function personnel.
•Excellent organization, communication, and collaboration skills.
Desirable Requirements:
•Radiopharmaceutical and/or aseptic manufacturing experience is a plus.
•Demonstrated experience managing and/or mentoring of team members is a plus.
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: People and CultureNovartis.
Pay transparency statement: The pay range for this position at commencement of employment is expected to be between $112,800 and $169,200 a 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 hear more about Novartis and our career opportunities, join the Novartis Network here: Novartis Talent Pool.
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:
Location: Onsite - Millburn, NJ.
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 Compliance professionals to help us reach our ambitious goals.
As a Sr. QA Compliance Specialist, you are responsible for supporting all functions and activities within scope of the QA Compliance department. This role is accountable for the oversight and implementation of the change control system at the site, including RegCMC input and delivery for regulatory-relevant changes.
Key Responsibilities:
•Serve as primary liaison with Global and Country Quality/Regulatory teams (i.e., CMC and Labeling) for assessing the regulatory relevance, submission strategies, and source documents required for Change Controls owned by the site.
•Evolve Change Control practices and be an innovator of compliance best practices across the RLT platform.
•Maintain knowledge of the global regulatory dossiers for the site's products and facilitate the site's contributions, review, or edits to such documents in support of regulatory filings.
•Enhance site understanding of relevant regulatory issues and topics through training and collaboration on projects; coach and support Change Owners as necessary.
•Routinely monitor and report to site leadership key metrics regarding site compliance in executing Change Controls.
•Work closely with the Data Integrity (DI) officer and site departments to ensure site adherence to cGMP and regulatory filings, as applicable.
•Ensure compliance with the legal requirements of the applicable Health Authorities (GMP Certificates, Import Certificates, Export Certificates, Manufacturing Authorizations, etc.).
•Support Global Compliance initiatives, departmental projects and objectives according to agreed timelines and standards in the given area of competency and support adherence to compliance with GMP.
•Influence a culture of compliance and lead innovative compliance initiatives/projects across the site.
•Mentor other QA Compliance personnel or contractors as needed.
Additional Notes:
•This role is Monday-Friday, 1st shift on-site at our Millburn, NJ location.
Role Requirements
•Bachelor's degree preferably in a STEM (Science, Technology, Engineering & Math) field or related relevant degree.
•7+ years' experience in Quality Assurance/QA Compliance within the pharmaceutical and cGMP regulated industry required.
•Demonstrated ability with leading, executing, and documenting both complex change controls and regulatory strategies (e.g. launches, divestments, PAS, and CBE filings (US) as well as foreign equivalents).
•Demonstrated ability to create and cultivate strong relationships across site departments as well as other site & global function personnel.
•Excellent organization, communication, and collaboration skills.
Desirable Requirements:
•Radiopharmaceutical and/or aseptic manufacturing experience is a plus.
•Demonstrated experience managing and/or mentoring of team members is a plus.
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: People and CultureNovartis.
Pay transparency statement: The pay range for this position at commencement of employment is expected to be between $112,800 and $169,200 a 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 hear more about Novartis and our career opportunities, join the Novartis Network here: Novartis Talent Pool.
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
