Senior Manager Facilities and Equipment Qualification
Senior Manager Facilities and Equipment Qualification
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$ 108500 - 201500
1 Vacancy
Job Description
Band
Level 4Job Description Summary
#LIOnsiteThis position is based on the East Hanover NJ campus and cannot be located remotely.
About the role:
The Senior Manager Qualification is responsible for ensuring compliance to the regulatory requirements of the facilities utilities equipment and analytical instruments qualification processes and activities performed in the Engineering department of the Novartis Cell and Gene Therapy East Hanover NJ facility. Recommends and implements improvements of the qualification process. Performs a variety of routine and nonroutine tasks related to facilities utilities equipment and analytical instruments qualification as managing and overlooking qualification program projects and changes. Reviews and approves qualification documents such as installation operational performance qualification (IOPQ) and computer software validation (CSV) protocols reports traceability matrix (TM). Prepares and/or approves risk and impact assessments validation master plans (VMP) and other evaluations. Supports Production Unit (PU) Technical Development (TD) Operations (OPS) Quality Control (QC) and Quality Assurance (QA) departments. Plans and manages qualification activities of manufacturing equipment laboratory instruments facilities and utilities. Ensures efficient timely GMP and compliant of qualification activities. Manages internal Qualification Engineers and provides oversight of 3rd party qualification service provider contracts.
Job Description
Key Responsibilities:
Manages qualification program:
- Manage qualification activities in compliance with corporate policy local procedures and regulatory expectations.
- Determines qualification requirements based on a worstcase matrix approach for the site.
- Manage and develop in alignment with Production Analytical Operations (QC) Quality Assurance (QA) and Analytical / Process Development teams qualification projects and plans and identifies the critical to quality parameters impacting qualification activities.
Prepares and/or approves Qualification Master Plans risk and impact assessments protocols and summary reports and coordinates review and approvals of the documents.
Reviews/approves/manages executed installation operational performance qualification (IOPQ) and computer system validation (CSV) protocols Periodic Reviews and Requalification.
Authors/reviews/updates/assists in developing departmental standard operating procedures (SOPs) Work Procedures (WP) and qualification programs.
Ensures that all activities are in compliance with cGMP Health Authority regulations and the Novartis Policies.
Supports and provides oversight of 3rd party/ vendor qualification activities if applicable.
Assists in investigation of Out of Specification (OOS) Out of Expectations (OOE) product deviations. or rejects related to equipment laboratory instruments facilities and utilities in area of responsibility.
Trains colleagues and external employees on qualification and validation practices.
Essential Requirements:
- Education: BS degree in scientific discipline or engineering or equivalent experience.
- 7years of Pharmaceutical Industry facility utility and cell/gene production equipment & laboratory instrument qualification and CSV experience or applicable experience in a related area in the pharmaceutical industry.
- Knowledge of cGMPs and understanding of the concepts of GLP FDA and Health Authority guidelines applicable regulations and standards routinely used in the industry (ANSI ISO GAMP ATMP).
- Thorough understanding of environmental control programs and aseptic manufacturing areas.
- Supervisory or management experience: may include leading teams or projects.
- GMP Qualification & Validation Project Management and Computer system Validation (CSV)12. Highly knowledgeable in cGMP and regulatory requirements including CSV requirements and 21 CFR Part 11 compliance. 8. Detailed understanding of quality assurance standards principles theories and technique.
Skills required:
- Technical skills in the understanding of pharmaceutical facilities utilities manufacturing and laboratory equipment/instruments operation.
- Team Building / People Challenges / Collaborating across boundaries
- Interpersonal and operational savvy / Good communication and negotiations skills.
- Strong technical writing skills for generating high quality protocols & technical reports
- Good project management skills decisionmaking ability.
- Stakeholder Engagement.
- Must be able to work independently.
- Root Cause Analysis (RCA).
Desirable Requirements:
- Direct people management experience highly desirable
Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between: $108500 and $201500/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)
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 calland let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Range
Skills Desired
Api (Application Programming Interface) Api (Application Programming Interface) Automation BackEnd Development Business Continuity Change Control Chemistry Design Development Electronic Components General Hse Knowledge Including Gdp Java (Programming Language) Knowledge Of Capa Knowledge Of Gmp Kubernetes Managing Performance Improvement Manufacturing Production Mathematical Optimization Project Commissioning Project Engineering Project Reactjs Risk Management Root Cause Analysis (RCA) Scheduler 2 moreRequired Experience:
Senior Manager
Employment Type
Full-Time
