QA Quality Manager/Senior Manager
QA Quality Manager/Senior Manager
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$ 98700 - 183300
1 Vacancy
Job Description
Job Description Summary
The Quality Manager is responsible for product development for new product supporting IND filing through the BLA filing. Product scope includes cell therapy products gene therapy products vectors and plasmids. Support compliance during development manufacturing analytical testing and tech transfer. Performing batch release activities and managing deviations and escalations related to the product.Location: East Hanover NJ #LI- Hybrid
Job Description
Key Responsibilities:
- Support a discipline and/or provide a service individually or within a team of associates. May provide functional expertise to Line Unit and other QA Units in area of responsibility
- Write review decide on approval and/or release of GMP-relevant deliverables and/or related tools as per area of responsibility in order to ensure compliance with cGMP and project quality deliverables.
- Manage project related activities (e.g. TRD product portfolio development of new tools processes Quality initiatives Quality Manual implementation Quality Plans Quality Risk Assessments training activities qualification and facility upgrade activities IT validation projects) as per area of responsibility.
- Support Project management functions as a project team member.
- Provide support to TRD line functions in GMP related topics as per area of responsibility.
- Comply with internal and external guidelines regarding quality and safety (Quality Manual regulatory cGMP guidelines Health Authority guidance SOPs etc.).
Essential Requirements:
- Bachelors Degree and at least 10 years pharma qualityor pharma operations
- Functional experience with cell banks plasmids adeno-associated vectors and lenti-viral vectors required
- 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 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.
The salary for this position is expected to range between $98700 and $183300/year. The final salary offered is determined based on factors like but not limited to relevant skills and experience and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and depending on the level of the role eligibility to be considered for annual equity awards.
US-based eligible employees will receive a comprehensive benefits package that includes health life and disability benefits a 401(k) with company contribution and match and a variety of other addition employees are eligible for a generous time off package including vacation personal days holidays and other leaves.
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 sex national origin age sexual orientation gender identity or expression marital or veteran status disability or any other legally protected status.
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 to perform the essential functions of a position please send an e-mail to or call 1 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Salary Range
$98700.00 - $183300.00Skills Desired
Agility Analytical Development Auditing Audit Management Business Partnering Change Control Continued Learning Health Authorities Influencing Skills Knowledge Of Capa Qa (Quality Assurance) Quality Management Risk Management Root Cause Analysis (RCA) Self-Awareness Six Sigma Sop (Standard Operating Procedure) Technological ExpertiseRequired Experience:
Senior Manager
Employment Type
Full-Time
