GCP Compliance Manager (Global Clinical Operations)

GCP Compliance Manager (Global Clinical Operations)

Job ID

Mar 19, 2024

USA

About the Role

Location: On-site/Hybrid #LI-Hybrid

The GCP Compliance Manager (Global Clinical Operations) is accountable for the compliance oversight and control of regulated GCO activities focusing on GCO wide activities potentially having a high impact on GCO ability to deliver as per objectives, as per assignment. This role contributes to all compliance activities supporting the three pillars of GCP Compliance as per focus above, issue management, audits & inspections particularly system/process audits and global inspections supporting authorizations and GCO self-strategy delivery.

The GCP Compliance Manager (GCO) provides GxP expertise and may be referred in providing GCP Compliance support to other functions, compliance, process, training and risk groups. This role promotes a product quality culture within GCO supporting the GCP Compliance Head (GCO) focusing on quality and compliance being increased and sustained and on active risk management.

Key Responsibilities:

• Accountability for the compliance oversight and control of regulated GCO activities focusing on GCO wide activities potentially having a high impact on GCO ability to deliver as per objectives, as per assignment.

• Provide GxP expertise and may be referred in providing GCP Compliance support to other functions, compliance, process, training and risk groups.

• As per focus area and assignment, management of GCO wide systemic quality issues, deviations and quality events management.

• Management of the GCO audits and inspections landscape and coordination of system/process audits & global inspections supporting authorizations including inspection readiness.

• Delivery of the GCO self-assessment strategy related checks and controls.

• Coordination of GCO cross-functions risk assessments as per scope and as assigned.

• Contribute to the execution of the GCO GCP Compliance strategy under the leadership of the GCP Compliance Head (GCO).

• Drive the compliance oversight and control of regulated GCO activities focusing on GCO wide activities potentially having a high impact on GCO ability to deliver as per objectives, as per assignment, working closely with the relevant functions across GCO, involving and collaborating as required with GDD and the wider organization, such as Quality Assurance.

• Provide GxP expertise and may be referred in providing GCP Compliance support to other functions, compliance, process, training and risk groups.

Diversity & Inclusion / EEO

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 [email protected] or call +1 [Register to View]
• Sandoz: e-mail [email protected] or call: +1-[Register to View]

Role Requirements

• Advanced degree in science, engineering or relevant field.

• 8+ years industry experience specifically in clinical operations with an advanced knowledge 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 mindset.

• 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.

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

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

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

Division

Development

Business Unit

GCO GDD

Location

USA

Site

East Hanover, NJ

Company / Legal Entity

Novartis Pharmaceuticals

Functional Area

Research & Development

Job Type

Full Time

Employment Type

Regular

Shift Work

No