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Sr. GCP QA Auditor - Remote
Raleigh | careers.medpace.com |
Job Summary:
Due to our rapid growth we need experienced industry professionals to join our Quality Assurance (QA) team. This position will support and audit global trials in a variety of therapeutic areas, maintaining organizational and regulatory standards throughout our company.
This is a vital role in our Quality Assurance department, whose success relies upon on the finely tuned skills and background of our QA Auditors.
Responsibilities :
• Act as a Quality Program Lead on clinical trials by supporting national and international regulatory standards and guidance for pharmaceuticals, biologics and medical devices.
• Develop audit management plans and audit strategy with clients for ongoing clinical trials.
• Coordinate and conduct internal system audits and external investigative site/vendor audits in accordance with Good Clinical Practice (GCP) guidelines;
• Participate in the development of departmental standard operating procedures, work instructions, forms, and templates;
• Assess validated state and security of proprietary and cloud based software.
• Develop training materials and applicable interactive tests and proficiency training including company-wide regulatory training (ICH/GCP);
Qualifications :
• Bachelor’s degree in life sciences or related field;
• 5+ years of experience in a QA department in a related industry;
• Experience conducting audits of vendors and investigative sites;
• Experience hosting regulatory authorities and interacting with sponsor/client representatives;
• Independent thinking and planning ability;
• Knowledge and application of Good Clinical Practice (GCP) is required;
• Medical Device and or Phase 1 experience is a plus;
• Ability to travel up to 30%-40% of time;
• Excellent written and verbal communication skills;
• Exceptional teamwork skills; and
• Ability to work independently.
Medpace Overview :
Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach.
We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries.
Why Medpace?:
People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.
The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.
Medpace Perks
• Hybrid work-from-home options (dependent upon position and level)
• Competitive PTO packages – starting at 20+ days
• Company-sponsored employee appreciation events
• Employee health and wellness initiatives
• Flexible work schedule
• Competitive compensation and benefits package
• Structured career paths with opportunities for professional growth
• Discounts for local businesses
Awards
• Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024
• Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility
What to Expect Next
A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.
EO/AA Employer M/F/Disability/Vets
Due to our rapid growth we need experienced industry professionals to join our Quality Assurance (QA) team. This position will support and audit global trials in a variety of therapeutic areas, maintaining organizational and regulatory standards throughout our company.
This is a vital role in our Quality Assurance department, whose success relies upon on the finely tuned skills and background of our QA Auditors.
Responsibilities :
• Act as a Quality Program Lead on clinical trials by supporting national and international regulatory standards and guidance for pharmaceuticals, biologics and medical devices.
• Develop audit management plans and audit strategy with clients for ongoing clinical trials.
• Coordinate and conduct internal system audits and external investigative site/vendor audits in accordance with Good Clinical Practice (GCP) guidelines;
• Participate in the development of departmental standard operating procedures, work instructions, forms, and templates;
• Assess validated state and security of proprietary and cloud based software.
• Develop training materials and applicable interactive tests and proficiency training including company-wide regulatory training (ICH/GCP);
Qualifications :
• Bachelor’s degree in life sciences or related field;
• 5+ years of experience in a QA department in a related industry;
• Experience conducting audits of vendors and investigative sites;
• Experience hosting regulatory authorities and interacting with sponsor/client representatives;
• Independent thinking and planning ability;
• Knowledge and application of Good Clinical Practice (GCP) is required;
• Medical Device and or Phase 1 experience is a plus;
• Ability to travel up to 30%-40% of time;
• Excellent written and verbal communication skills;
• Exceptional teamwork skills; and
• Ability to work independently.
Medpace Overview :
Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach.
We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries.
Why Medpace?:
People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.
The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.
Medpace Perks
• Hybrid work-from-home options (dependent upon position and level)
• Competitive PTO packages – starting at 20+ days
• Company-sponsored employee appreciation events
• Employee health and wellness initiatives
• Flexible work schedule
• Competitive compensation and benefits package
• Structured career paths with opportunities for professional growth
• Discounts for local businesses
Awards
• Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024
• Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility
What to Expect Next
A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.
EO/AA Employer M/F/Disability/Vets