摘要
This role is required to be on-site in Morris Plains, NJ. Novartis is unable to offer relocations support for this role: please only apply if this locations is accessible for you.
365 days a year, we aspire to be the best manufacturer of Cell & Gene therapies to ensure our patients have the treatments they need to live longer, healthier lives
About the Role
Key Responsibilities:
- Responsible for management of Technical Compliance Investigations and Signal Review
- Perform complaint investigations and facilitate escalation as needed
- Complete and maintain certification through the Investigation Certification Program (ICP) to supporting compliant investigations and site investigations as needed
- Manage, monitor and coordinate records in1QEM System relating to complaints
- Contributing and providing report for APQRs for Complaints, BPDR, Recall and FARs
- Function as Complaint liaison for CGT between Customer Complaint group, CPO QA and Country CPO
- Support Inspection and Audit Management and Self-inspection program
- Quality System Ownership for QMR reporting and Support as onsite SME for eDoc Systems
- Site Master Validation Plan and Sub-Plan Governance and Site Master Files Management
- QMS Functional Representation Role
Essential Requirements:
- BA/BS in Chemistry, Microbiology or Biological Sciences or related degree.
- 4+ years of related pharmaceutical experience, preferably to include cell gene therapies
- Experience with Global systems
- Experience in Quality Control, Quality Assurance, Documentation Control, Compliance
- Knowledge of GMPs/Regulatory
- Knowledge of deviation, CAPA, Compliant, BPDR, Recall, Change Control, manufacturing processes, Packaging process, Regulatory inspection, technical writing
- Demonstrate Excellent leadership
The pay range for this position at commencement of employment is expected to be between $92,800 and $139,200 per year; however, base pay offered may vary depending on multiple individualized factors, including market locations, job-related knowledge, skills, and experience. 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.
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
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Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers who are focused on building and advancing a culture of inclusion that values and celebrates individual differences, uniqueness, backgrounds and perspectives. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to fostering a diverse and inclusive workplace that reflects the world around us and connects us to the patients, customers and communities we serve.
Accessibility & 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 to perform the essential functions of a position, please send an e-mail to [email protected] or 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.
