Description
A biopharmaceutical company located in Santa Clara is urgently seeking a Senior QA Specialist, reporting to the Senior Manager QA.Essential duties & responsibilities:
- Assist with development of the audit strategy and programs
- Provide oversight and direct training of CQA staff in all aspects of the quality management function; especially as it relates to conducting and hosting auditing
- Identify/monitor GCP compliance risks; provide guidance on mitigation/management of such risks
- Lead and/or support GCP inspection readiness and inspection management activities
- Represent CQA in Study Management Team, GCP Compliance Committee, and Clinical Quality System review and improvement teams
- Ensure timely development of audit schedule, assist in the preparation and conduct audits in support of all GCP activities as directed
- In collaboration with the Director, CQA, ensure that appropriate Standard Operating Procedures are in place
- Interpret policies, standards, and regulations, and applies to evaluation of potentially critical problems Exercises sound and balanced judgment in evaluating compliance of quality systems, processes, procedures, and protocols
- Travel required up to 35% as needed (travel may be domestic and international)
Requirements:
- Minimum of 10 to 12+ years experience in the pharmaceutical/biotechnology industry
- Minimum of 8+ years auditing in one of the following areas: GCP, GLP
- Expert knowledge of technical concepts required for all aspects of GCP Auditing
- Extensive experience supporting regulatory authority inspections of clinical research activities
- Experience managing quality and compliance projects and programs
- Strong working knowledge of clinical development and operations
- Strong communicator with strong verbal, written communication and presentation skills
- Experience in providing training on key quality and regulatory compliance information
- Strong Partnering and collaboration skills
- Balance approach to issue management and mitigation planning
- Accomplished knowledge of global and local GCP regulations
Education:
- Bachelor of Science Degree or higher
- RQAP-GCP or other certifications are highly desirable
To find out more about Real please visit www.realstaffing.com