Clinical Quality Assurance Manager
|Job Title:||Clinical Quality Assurance Manager|
|Contact Name:||Pavlina Bullaj|
|Job Published:||April 11, 2017 16:16|
Clinical QA Specialist/Manager
SciPro Global are currently looking for a Clinical Quality Assurance Manager. We are working with one of our key clients - a Seattle based Biopharmaceutical Company committed to discovering, developing, and commercializing small-molecule and protein therapeutics for disorders of the CNS.
Working on a number of clinical-stage development programs across different CNS disorders, the client is currently looking for a Clinical Quality Assurance Manager to come in and provide support and proactive strategic planning for QA oversight of clinical development activities. As the Clinical QA Manager, you will be responsible for domestic and international clinical and vendor audits and will work with internal stakeholders, participate cross functionally, and use your creative problem solving skills on complex compliance issues.
As part of your role, you will conduct audits, facilitate and support regulatory authority GCP inspections, both at clinical sites and at the client site. Additionally, you'll develop and/or review CQA SOPs and associated documents.
- Participating in the evaluation and qualification of CRO's and other service providers
- Conducting external and internal audits to assess compliance with GCP requirements, investigational plans and company standards for clinical trial-related activities
- Communicating audit findings to audit stakeholders ensuring understanding as well as collaborating with auditees to ensure appropriate implementation of Corrective and Preventive Action Plans (CAPAs), addressing root causes
- Tracking, reviewing, approving, and assessing the adequacy of CAPAs
- Assisting with the preparation, coordination, and management of regulatory agency inspections
- Reviewing and updating CQA SOPs, identifying the need for new CQA SOPs, and developing new CQA SOPs, as needed
- Must have a Bachelor's Degree in a Life Science related field
- Minimum 5 Years relevant pharmaceutical experience (GCP/clinical quality assurance)
- Minimum of 2 years of GCP auditing experience
If you think this is something you would be interested in, please apply directly & I will be in contact shortly, alternately please call me on 415 621 9281 for more information.
I look forward to hearing from you!
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