REMOTE Quality Assurance GCP/GLP Manager - long term contract, possible contract to hire
Can work remotely
The Quality Assurance GCP Manager is responsible for arranging, conducting and reporting on GCP audits of clinical research organizations, vendors, and systems as well as oversight of the Clinical Operations and Clinical Trials. Participates in cross-functional teams providing guidance and risk-based options. Reviews study documents and checks for consistency and appropriate standards and practices. Assists in the creation and maintenance of audit tools. When appropriate, prepares and/or revises GCP SOPs and Work Instructions. Works with cross-functional teams to provide GCP advice. Maintains good working relationships and communication with GCP customers and staff.
Essential duties include:
• Performs Quality Control (QC) of clinical and non-clinical data as well as clinical documents (protocol, IB, etc.).
• Ensures Clinical Operations and Clinical Trials are complaint with FDA and ROW regulatory expectations;
• Arranges, conducts and reports on GCP audits of clinical research organizations, investigators, vendors, and systems
• Develops and maintain quality procedures aligned with GCP concepts
• Works within cross-functional teams, ensuring compliance to regulatory guidance and internal document standards;
• Works directly with CRO’s and other external contractors and collaborators, managing the chain of communication related to GCP compliance;
• Approximately 5-10% travel per year - US travel
Suitable candidates will possess a Bachelor’s degree in a Life Science or Engineering, and 8+ years of Quality Assurance experience in the Biotechnology and/or Pharmaceutical industry. Extensive knowledge of clinical trials in the US and EU and regulatory standards at all phases of drug development is preferred.
• Clear record of success as a QA Manager in a biopharma or pharmaceutical environment;
• Clear understanding of FDA and international regulatory requirements;
• Adept at prioritizing and completing tasks in a high-pressure environment;
• Proven leadership within a cross-functional project team;
• Ability to persuasively and effectively interact with partners, collaborators and CRO’s;
• Demonstrated ability to anticipate and address issues;
• Exceptional oral and written communication skills including excellent technical writing abilities.
With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—
providing you with opportunities to work on today’s most challenging, research-intensive, and relevant
projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help
advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000
scientific professionals last year.
You pursued a career in science to fuel your quest for knowledge and your desire to make the world
a better place. Let Kelly fuel your career—connect with us today.
As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit URL blocked - click to apply and connect
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Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,
Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is
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Product Quality Assurance
Good Clinical Practices (Gcp)