GCP Laboratory Compliance Lead

Your key responsibilities:
• Support start-up and operation of our newly created clinical Bioanalytics group which undertakes method validations and the analysis of clinical trial samples applying Good Laboratory Practices (GLP) while assuring Good Clinical Practice (GCP) compliance (GCLP: "Good Clinical Laboratory Practice").
• Accountable for leading global quality implementation and compliance activities including management of controlled processes and laboratory instruments and systems, mandatory training, deviation reporting, and quality metrics.
• Drive operational excellence and efficiency through departmental document templates, process oversight, optimization, and training.
• Provide direction to various groups and functions to achieve a high level of compliance with established standards, best practices, and regulatory requirements.
• Support identification, overview, and prioritization of compliance improvement activities to enhance regulatory compliance within global Bioanalytics.
• Identify areas of concerns / deficiencies and propose improvement or training.
• Collaborate with Quality Assurance and Bioanalytics Leadership Team to support preparation, conduct and follow up of audits and/or health authority inspections. Oversee preparation and completion of deviation reports and Corrective Action Plans, if any.
• Maintain expertise in regulatory guidelines for ICH, FDA, and other Health Authorities (HA). Point of contact providing consolidated feedback to HA on behalf of global Bioanalytics.

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 (877)395-2339
• Sandoz: e-mail [email protected] or call: +1-609-422-4098

Role Requirements

Essential Requirements:
• MS equivalent in a relevant discipline with 10+ years of experience in the pharmaceutical / CRO / regulated industry
• 5 years of GCP (for laboratories) and GLP regulations experience
• Strong scientific, process, and operational background
• Fundamental understanding of Bioanalytics (preferably in the area of biologics, cell- and gene therapies) and quality management systems and concepts

Why Novartis: Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture

You'll receive:
You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.
https://www.novartis.com/careers/benefits-rewards

Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

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 e-mail to [email protected] call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $136,800 - 205,200/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: 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

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
Biomedical Research

Business Unit
Translational Medicine

Location
USA

Site
Cambridge, MA

Company / Legal Entity
NIBRI

Functional Area
Research & Development

Job Type
Full Time

Employment Type
Regular

Shift Work
No