Novartis Hiring for QA Compliance Specialist job in Millburn Full Time

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 QA Compliance Specialist, you are responsible for supporting all functions and activities within scope of the QA Compliance department.

Key Responsibilities:

• Support the Compliance department leads in all functional areas as directed (quality management systems (QMS) and exceptions management, audits/inspections management, document control, and change control).
• Work collaboratively with all departments to support, maintain, and improve compliance, operational, and quality standards.
• Assist with internal and external audits to ensure that the manufacturing facilities, equipment, and procedures meet regulatory requirements.
• Assist in the development and review of SOPs and other documentation to support the Compliance department.
• Ensure that the document control systems are maintained in compliance with cGMP regulations and company policies.
• Contribute to investigations of deviations as necessary to identify the root causes and recommend corrective actions.
• Participate in continuous improvement initiatives to enhance the quality and efficiency of the site’s quality systems.
• Support Global Compliance initiatives, departmental projects and objectives according to agreed timelines and standards.

Additional Notes:
• This role is Monday-Friday days, on-site at our Millburn, NJ location.

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
• Bachelor’s degree preferably in a STEM (Science, Technology, Engineering & Math) field or related relevant degree.
• 3+ years’ experience in Quality Compliance, Quality Assurance, Auditing, and/or Regulatory roles within the pharmaceutical industry.
• Knowledge of cGMP regulations, industry standards, and quality compliance/assurance principles.
• Demonstrated ability to create and cultivate strong relationships across site departments as well as other site & global function personnel.
• Strong analytical skills and attention to detail.
• Excellent organization, communication, and collaboration skills.
• Ability to work both independently and as part of a team.

Desirable Requirements:
• Radiopharmaceutical and/or aseptic manufacturing experience 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 Culture | Novartis.

Pay transparency statement: The pay range for this position at commencement of employment is expected to be between $88,000 and $132,000 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 [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 hear more about Novartis and our career opportunities, join the Novartis Network here: Novartis Talent Pool.