Clinical QA Manager
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Location
San Francisco, California
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Sector:
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Job type:
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Salary:
Competitive
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Contact:
Cortland Hotz
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Contact email:
c.hotz@hamlynwilliams.com
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Salary high:
0
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Salary low:
0
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Published:
about 1 year ago
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Expiry date:
2020-03-01
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Startdate:
ASAP
A fast growing and innovative biopharmaceutical company is looking to hire an experienced Clinical Quality Assurance Manager to join their team.
Position Summary:
This person with work cross functionally with the Clinical Quality and Corporate Quality team. Some of the main responsibilities include:
- Plans and transforms policies, systems and procedures associated with clinical quality
- Contributions in external audits
- Completes internal audits
- Provides knowledge and leadership to various departments to assure clinical trials are conducted in compliance with Good Clinical Practices (GCP)
- Assitis Contract Research Organization staff in the proper execution of GCP
- Works with internal stakeholders in complying with and developing new SOPs
- Demonstrates the highest level of detail within clinical quality compliance
Key Responsibilities:
Position specific requirements
- Familiarity in conducting clinical trials
- Knowledge with internal audits of clinical quality systems
- Involvement in working with CAPA closure and audit finding remediation
- Capable of maintaining databases
Other valuable capabilities
- Familiarity with electronics solutions supporting clinical trials
- Extensive knowledge of MS Word, Excel, Access, Visio and PowerPoint
- Proven ability to work cross functionally
Knowledge, Skills and Experience:
- Minimum 5 years’ experience in Biopharma industry with 5 years’ experience in clinical quality assurance or clinical operations.
- Bachelor’s degree required, science related field preferred