What are the responsibilities and job description for the GCP Quality Consultant position at Redbock - an NES Fircroft company?
QUALITY CONSULTANT (12-month, Potential for Extension)
SUMMARY:
GCP Quality Assurance professional needed to support Early Access Program compliance and quality oversight for a biopharmaceutical innovator.
DUTIES & RESPONSIBILITIES:
* Vendor oversight
* Lead compliance activities for GCP, ICH, Regulatory, SOP, and systems adherence
* Lead risk assessment, root cause analysis, CAPAs and audit and regulatory filing support
* Quality reviews of relevant documents and records
* Other related duties, as required
QUALIFICATIONS & REQUIREMENTS:
* 10 or more years of relevant life sciences quality experience, including extensive pharmaceutical/biopharmaceutical Quality and Quality Systems compliance experience and EAP GCP expertise
* Deep understanding of GxP regulations and standards
* Proven experience with Early Access Programs and related quality and quality systems compliance
* Excellent written, verbal, interpersonal, and teamwork communication skills, and outstanding attention to detail
* Relevant bachelor's degree
LOCATION:
Work can be performed remotely from home, during U.S. Eastern Time Zone business hours. Contenders should be willing to travel, if necessary