R&D / Tech Dev Quality Lead, Compliance
R&D / Tech Dev Quality Lead, Compliance
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$ 138600 - 257400
1 Vacancy
Job Description
Band
Level 5Job Description Summary
The TRD Quality Lead Compliance is responsible to oversee GMP compliance in local TRD Site Operations (Pilot Plants and GMP laboratories). Leads conversations and alignments on compliance matters between the QP/RP the global TRD QA compliance team and TechOps Compliance and is in contact with local health authorities. Is part of the TRD QA Compliance network. Continuously monitors GMP performance & status against internal and external regulations and develops improvement strategies in close collaboration with business partners as deemed necessary.Location: East Hanover NJ LIOnsite
Job Description
Key Responsibilities:
- Overseas and ensures GMP compliance at the Site supporting the Pilot Plants and GMP laboratories with local regulations and Novartis standards.
- Responsible for the local inspection management including communication with internal audit teams partners and health authorities.
- Drives preparation activities in close alignment with business partners and is acting as moderator for audits inspections and selfinspections.
- Ensures successful and continued maintenance of GMP certifications at the local Site.
- Supports the QP/RP or local Quality Head in the communications with internal and external authorities and inspectors.
- Provides leadership and support in the development of corrective and preventive action plans (CAPA) in collaboration with the business partner.
- Oversee the monitoring for progress of corrective and preventive actions to ensure the issues are adequately addressed completed and appropriately documented.
- Ensures oversight and compliance with the Novartis Quality Management system ensures that the Quality Management System is implemented and maintained in a suitable adequate and effective manner in alignment with the business partner.
- Ensures harmonization and continuous improvement of the Quality Management System in alignment with global TRD QA and the local business partner.
- Is responsible for Quality reporting KQIs at the local Site supports incident management activities.
- Oversees and organizes the local Quality review board in close collaboration with Global TRD QA.
- Ensure continuous learning and GMP improvements at the local Site based on insights from inspections deviation trending and reported incidents.
- Closely collaborates with internal and external partners providing benchmarks.
- Reports back to the business partner and TRD QA Management.
Essential Requirements:
- Bachelors Degree and at least 10 years pharma quality or pharma operations
- Fundamental broad understanding and knowledge of quality standards and policies in Drug Substance/Drug Product/manufacturing and control.
- Experience with Health Authority Inspections (FDA and EMA in particular) and knowledge of RegCMC requirements for Health Authority submissions (INDs IMPDs NDAs ANDAs MAAs).
- Good experience in technical drug development as well as in Quality Assurance and Quality compliance departments.
- Experience in Technical Operations or equivalent experience from external company is preferred.
- Ability to contribute to matrix teams with the necessary strategic thinking quality awareness and implementation skills.
- Computer literacy demonstrated along with readiness to learn new systems and associated processes.
- Excellent organizational and project management as well digitalization skills.
- Ability to influence people negotiate and communicate.
Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $138600 and $257400/year; however while salary ranges are effective from 1/1/25 through 12/31/25 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 signon 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 atwill 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.
EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers. 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 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
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 email to call 1 (877)and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Range
Skills Desired
Agility Auditing Audit Management Business Partnering Continued Learning Drug Development Employee Performance Evaluations Health Authorities Influencing Skills ISO 9001 Leadership Organizational Savvy People Management Qa (Quality Assurance) Quality Management Quality Management Systems (QMS) Risk Management Root Cause Analysis (RCA) SelfAwareness Stakeholder Management Technological Expertise Vendor ManagementEmployment Type
Full-Time
