Sr. Compliance Specialist

Job Description Summary

The Senior Compliance Specialist is responsible for maintaining the Morris Plains QMS and Inspection Management.

This role is required to be on-site in Morris Plains, NJ. Novartis is unable to offer relocation support for this role: please only apply if this location 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.

LI- #onsite

 

Job Description

Key Responsibilities:

• Responsible for Trending of Deviations Quarterly and ICP (Investigator Certification Program)
• Maintaining ICP Certification to support Quality records within the QMS system
• Maintaining Novartis Auditor Certification
• QMS Functional Representation Role
• Market Notifications (BPDR, PDR, Recall)
• APQR Governance- author and/or review the PQR/APQR data contributions aligned with compliance activities.
• Quality Plan Management
• Risk Assessment Approval and oversite of Governance
• Monthly KPI/KQI Reporting
• QMR Management (Monthly, Quarterly)
• Compliance Alert Management
• Audit/Inspection Management (Logistics, Response, CAPA Governance)
• Aseptic Team Member
• Data Integrity Point of contact and support the DI Plan
• Change Control Management Support to Sr Reg CMC Facilitator

Essential Requirements:

• BA/BS in Chemistry, Microbiology or Biological Sciences or related degree.
• 8+ years of related pharmaceutical experience, preferred to include cell gene therapies
• At least 3 years of experience with Change Control and Risk Assessment is a must
• 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
• Demonstrate a proven track record with Health Authorities and Customer Audits

The pay range for this position at commencement of employment is expected to be between $118,400 and $177,600 per year; however, base pay offered may vary depending on multiple individualized factors, including market location, 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.

 Commitment to Diversity and Inclusion:

The Novartis Group of Companies 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.

 

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 and reasonable accommodations

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