344923BR
May 09, 2022
USA

Job Description

766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.

JOB PURPOSE & IMPACT:
This position is responsible for managing the Navigate BioPharma CAPA program and assuring compliance with sponsor requirements, internal procedures and state and federal regulations as applicable for a bioanalytical laboratory supporting clinical trial/in vitro diagnostic development/nonclinical testing. The focus of this position includes but is not limited to managing the CAPA program, including issues and audit findings in compliance with applicable Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) regulations and Good Clinical Laboratory Practice (GCLP), College of American Pathologists (CAP), ISO 15189 guidances, as applicable.

ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Manage CAPA/Issue program to ensure compliance with internal procedures and applicable regulations. Evaluate and provide guidance on risk assessment and impact for quality events (deviations, CAPAs, complaints, audit findings)
• Participate in internal audits and support sponsor and regulatory audits
• Analyze quality-related data, identify issues or trends, and make recommendations to management
• Support Quality activities and provide Quality oversight within CLIA/biopharma laboratory to ensure compliance for specimen testing to applicable GCLP/GCP/GLP requirements and applicable regulations
• Develop and monitor quality improvement initiatives and quality metrics in the laboratory
• Perform quality review and approval of laboratory procedures, technical protocols/reports and testing records
• As a member of the Quality Department, support other departmental activities as assigned with the main responsibility of oversight of the CAPA program


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

Education:
o Minimum, BS/BA degree. Degree in medical technology, chemistry or life science preferred.
o Years of Experience Required: 7-10 years’ experience in a Quality role with a combination of experience in:
 GCLP/GCP/GLP and CLIA/CAP environments supporting all phases of clinical and nonclinical trials
 FDA regulated environment supporting companion diagnostics or molecular diagnostics


Required Skill Sets & Knowledge:
o Strong communication and collaboration skills
o Ability to give clear guidance to internal customers
o Strong working knowledge of the principles and practices of laboratory QA and QC
o Strong working knowledge of CLIA/CAP, GCLP, GCP, GLP
o Understanding of risk-based practices in a GCP/clinical trial, GLP/nonclinical testing laboratory environment
o Basic understanding of molecular biology, immunohistochemistry, flow cytometry, ligand binding a plus
o Good computer skills; WORD, EXCEL

Note: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

PHYSICAL DEMANDS
Note: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions

While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, and ability to adjust focus.

WORK ENVIRONMENT
Note: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Ability to sit for extended periods of time reviewing and generating electronic and written data. Use a computer keyboard. Ability to distinguish between colors (e.g. warning lights on equipment). Ability to view and interpret computer screens and hear audible equipment alarms. Ability to work in an open office work environment and in manufacturing and lab areas.

While performing the duties of this job, the employee is occasionally exposed to laboratory instruments.

The laboratory work environment involves moderate exposure to unusual elements including: extreme temperatures, fumes, smoke, unpleasant odors, and/or loud noises. The work environment involves exposure to potentially dangerous materials and situations that require following extensive safety precautions and includes the use of protective equipment. The noise level in the work environment is usually moderate. Interaction with laboratory equipment, samples, supplies, and laboratory personnel may be required whereby appropriate precautions are to be taken per the Company’s Safety and Injury, Illness and Prevention Plans.

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. Our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
ONCOLOGY
NAVIGATE BIOPHARMA SERVICES
USA
Carlsbad, CA
Quality
Full Time
Regular
No
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344923BR

Quality Manager, CAPA

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