Senior Global Process Control Manager, Trial Monitoring (Remote)

325285BR
Aug 10, 2021
USA

Job Description

Leading global quality process improvement and providing oversight and control of quality and compliance activities for 3,000+ global Trial Monitoring associates

The Sr. PCM is accountable for leading global quality process improvement and compliance activities and for oversight and control of quality in Trial Monitoring Operations. The role works collaboratively across TMO and with CQA to ensure improvement of quality and completion of risk management activities.

Your responsibilities include, but not limited to:

o Serves as Trial Monitoring subject matter expert and inputs into the development of new processes and SOPs that contribute to sustainable quality.
o Leads the development and implementation of quality improvement initiatives within Trial Monitoring, ensuring process changes are adequately communicated and managed
o Leads the tracking and reporting of compliance to the established clinical trial processes, regulations and training requirements.
o Ensures audits and inspections are supported, tracked and outcomes requiring corrective action are managed.
o Leads inspection preparation and execution for the Trial Monitoring Organization.
o Conducts and reports reviews of audit and inspection findings to identify trends and systematic gaps in processes.
o Ensures CAPA commitments are adequate, submitted and completed in a timely manner.
o Assists the Head of TMO and the Head of Monitoring Excellence to drive the quality and compliance mindset within TMO.

*Multiple positions available

Diversity & Inclusion / EEO

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.

Minimum Requirements

What you’ll bring to the role:
o College or University degree is required with significant life science experience; Advanced degree in life sciences is preferred
o A minimum of 5 years in a R&D regulated environment in a relevant pharmaceutical or health care company is required
o Extensive knowledge and experience in clinical operations, including ICH-GCP Process Control or ICH-GCP Quality Assurance systems and Health Authority regulations is required
o Demonstrated ability for leading initiatives with cross-functional teams and implementation of recommendations
o Preferable experience with Health Authority Inspection activities, including preparation and inspection support

** This position can be based remotely anywhere in the U.S. (there may be some exceptions based on legal entity registration). Please note that this role would not provide relocation as a result.

*** The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager. This position will require 25% travel.

WHY CONSIDER NOVARTIS?

799 million. That’s how many lives our products touched in 2019. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.

Imagine what you could do at Novartis!

Commitment to Diversity & Inclusion:

Novartis embraces diversity, equal opportunity and inclusion. 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.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.Novartis.com/network
Global Drug Development
GDO GDD
USA
East Hanover, NJ
Quality
Full Time
Regular
No
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325285BR

Senior Global Process Control Manager, Trial Monitoring (Remote)

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