GCP Quality Manager
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Accentuate Staffing is partnering with an established therapeutics company who is hiring for a Clinical Quality Manager. This is a direct hire opportunity, offering highly competitive pay and benefits, while working onsite. The ideal candidate has the will have experience in all aspects of clinical quality assurance and the demonstrated ability to perform clinical CAPAs, audits and trending analysis.
Responsibilities:
- Implement and maintain a comprehensive and GCP compliant quality program.
- Supports regulatory, audits and inspections of both company locations and their clinical sites.
- Develops SOPs and systems needed to comply with regulatory requirements.
- Performs all quality assurance and document record reviews of study files (site specific, clinical and pharmacological), study documentation and clinical study reports.
Requirements:
- Bachelors degree in a Scientific or Clinical related field.
- 8+ years of relevant pharmaceutical industry experience and direct GCP experience.
- Ability to execute clinical CAPAs, trending analysis and audits.
- Highly knowledgeable of ICH, GCP and EU guidelines.
