Clinical Quality Manager
Advanced Clinical
- Abbott Park, IL
- Contract
- Full-time
- SOP Strategy and Development: Lead revision and development of standard processes for the Clinical Development Team to ensure that all clinical research activities are conducted consistently and in compliance with applicable regulations and standards. Provide GCP guidance for clinical research activities and drive continuous improvement in all processes associated with the clinical compliance function. Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Assure SOPs appropriately reflect Corporate and Divisional policies.
- GCP Clinical Trial Audit Support: Key lead player in the preparation and overall support for internal/external audits as liaison with QA including responding to audit findings on behalf of the organization and performs pro-active internal compliance assessments. Oversee audit plans, audit reports and implement any necessary corrective or preventative actions to meet procedural or regulatory compliance requirements. Support project teams should investigational sites need support in preparing for an internal or external audit or an authority inspection. Conducts annual internal monitoring for scientific research funding.
- Vendor Qualification/Audits: Lead and conduct all clinical supplier/vendor qualifications and maintenance on the approved supplier list per corporate and divisional expectations.
- Education: Bachelor’s Degree (± 16 years) preferably in Life Sciences or an equivalent combination of education and work experience
- Minimum 5 years preferably in medical devices, clinical research experience, or related industry. At least 3 years of related work experience in a Quality role in pharma, medical device area and/or related clinical trial environment. GCP audit and CAPA experience required. Experience with Nutrition Research preferred.
- Fluent in English, any additional major language is a preferred asset; Excellent Communicator; Computer Literate. Ability to travel domestically or internationally as needed for the job responsibilities.
- Bachelor’s Degree (± 16 years) preferably in Life Sciences or an equivalent combination of education and work experience