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Remote Quality Assurance Manager - GCP

  • CyberCoders
  • Colorado, USA
  • Aug 14, 2019

Job Description

Minimum Required Skills:
Quality Assurance, GCP, QMS, CAPAs, ICH, FDA, EMEA, Clinical Research Organizations (CROs), CRO and clinical site audits

We are a clinical stage biopharm company founded in 2013. We are focused on developing and commercializing therapies to treat targeted patient populations suffering from serious diseases with a high unmet medical need.

We are looking for experienced individuals to join our team for a variety of roles. These roles are remote with excellent compensation packages.

Top Reasons to Work with Us

- REMOTE opportunity
- Breakthrough therapies
- Great time to join the company

What You Will Be Doing

- Provide GCP compliance oversight of internal systems and processes as well as those of CROs, vendors, and clinical investigator sites.
- Plans and conducts internal GCP audits. Manages all audit findings and resulting CAPAs.
- Completes clinical site audits and vendor audits and manages all resulting CAPAs
- Develops QA procedures for the GCP Quality Management System and educates staff on its function and importance.
- Establishes metrics for the Quality Management System to identify trends.
- Provide input on all procedures to ensure compliance with applicable GCP and ICH regulations.
- Provide GCP training to staff, as required.
- Lead all departments internally/CRO/clinical sites to ensure inspection readiness.
- Completes required SOP training as identified by in training matrix.

What You Need for this Position

- BS Degree
- Extensive QA experience within the pharmaceutical field
- Good Clinical Practices (GCP) experience
- Supervisory/Management experience
- Knowledge of International guidance's and requirements.
- Ability/Willingness to travel 20% of the time.

What's In It for You

- Competitive Compensation and Bonus
- REMOTESo, if you are a QA Manager with GCP experience, please apply today!

Applicants must be authorized to work in the U.S.

Security Clearance will be needed - therefore, only US citizens can be considered.Please apply directly to by clicking 'Click Here to Apply' with your Word resume!

Looking forward to receiving your resume and going over the position in more detail with you.

- Not a fit for this position? Click the link at the bottom of this email to search all of our open positions.

Looking forward to receiving your resume!


CyberCoders, Inc is proud to be an Equal Opportunity Employer

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, or any other characteristic protected by law.

Your Right to Work - In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire.

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