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Job ID

394828BR

About the role

Location: On-site/Hybrid #LI-Hybrid

The Good Clinical Practice Compliance (GCP) Manager (Program & Study) is accountable for the compliance oversight and control of regulated Global Clinical Operations (GCO)activities focusing on program/trial level delivery as per program(s)/trial(s) assignment. This role contributes to all compliance activities supporting the three pillars of GCP Compliance, issue management, audits & inspections as per program/trials’ selection and GCO self-strategy delivery.

The GCP Compliance Manager (Program & Study) is the single point of contact for Clinical Trial Teams for GCP Compliance, providing day-to-day support and ongoing quality oversight. This role promotes a product quality culture within GCO supporting the GCP Compliance Head (Program & Study), focusing on quality and compliance being increased and sustained and on active risk management.

Your Key Responsibilities:

  • Accountable for the compliance oversight and control of regulated GCO activities focusing on program/trial level delivery as per program(s)/trial(s) assignment.
  • Single point of contact for Clinical Trial Teams for GCP Compliance.
  • As per focus area and assignment, management and day-to-day support provided in program/trial level quality issues, deviations and quality events management.
  • Coordination and support to Clinical Trial Teams for audits and inspections based on program/trial/country’ selection and scope.
  • Delivery of the GCO self-assessment strategy related checks and controls.
  • Support cross-functions risk assessments if programs or trials identified and contribute to the monitoring of relevant indicators/metrics/thresholds.
  • Contribute to the execution of the GCO GCP Compliance strategy under the leadership of the GCP Compliance Head (Program & Study).
  • Drive the compliance oversight and control of regulated GCO activities focusing on program/trial level delivery as per program(s)/trial(s) assignment, working closely with the Clinical Trial Teams and the relevant functions across GCO, involving and collaborating as required with GDD and the wider organization, such as Quality Assurance.
  • Be the single point of contact for Clinical Trial Teams per program(s)/trial(s) assignment for GCP Compliance.
  • Manage and provide day-to-day support to the Clinical Trial Teams in program/trial level quality issues, deviations and quality events management, providing expertise in investigation, Root Cause Analysis (RCA) and CAPA development. Involve and collaborate as needed with the relevant functions across GCO, Development and the wider organization, such as Quality Assurance.

Position Title

GCP Compliance Manager (Program & Study)

Role Requirements

Key Requirements:

  • Advanced degree in science, engineering or relevant field.
  • 8+ years industry experience specifically in clinical operations and trial management with a strong understanding of clinical research international standards and regulatory requirements from Health Authorities. Audits and inspections experience highly desirable.
  • Organizational and analytical skills associated with a proficiency in quality management and continuous improvement.
  • Critical thinking ability and risk management and risk-based knowledge and approach.
  • Ability in partnering with a proactive and solution-oriented approach.
  • Strong skills to facilitate/optimize contribution of team members as individuals and members of a cohesive team.
  • Ability to work effectively in a matrix cross-functional environment.

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

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

Commitment to Diversity & 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 to unleash their full potential.

Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $158,400 - $237,600/year; however, while salary ranges are effective from 1/1/24 through 12/31/24, 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 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.

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

Job Type

Full Time

Country

USA

Work Location

East Hanover, NJ

Functional Area

Research & Development

Division

Development

Business Unit

GCO GDD

Employment Type

Regular

Company/Legal Entity

Novartis Pharmaceuticals

Commitment to Diversity & Inclusion:

We 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 to unleash their full potential.

Accessibility and Reasonable Accommodations: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please let us know the nature of your request, your contact information and the job requisition number in your message:

  • Novartis: e-mail us.reasonableaccommodations@novartis.com or call +1 (877)395-2339
  • Sandoz: e-mail reasonable.accommodations@sandoz.com or call: +1-609-422-4098

Shift Work

No

Early Talent

No

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Confirmed 12 hours ago. Posted 7 days ago.

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