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SME of Regulatory Affairs and Quality
4 months ago
Immediate need for a talented SME of Regulatory Affairs and Quality. This is a 12+ Months Contract opportunity with long-term potential and is located in Pleasanton, CA (Onsite). Please review the job description below and contact me ASAP if you are interested.
Job ID:23-53817
Pay Range: $60 -$65/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).
Key Responsibilities:
- Providing regulatory and quality consultation as a subject matter expert
- Submitting reports and communicating with IRB and regulatory agencies
- Staying abreast of developments in GCP and federal regulations regarding clinical research.
- Develops, reviews, strengthens, and approves all CTP-controlled documents including policies, SOPs, validation documents, change control, deviations and CAPAs.
- Develops, plans, and leads readiness for inspections and audits at CTP by GCP and GxP regulatory authorities, clinical investigator sites, and contract organizations.
- Ensures completion of all corrective actions associated with the quality system and ensures that the CAPA process is compliant with regulatory requirements.
- Leads in developing CTP staff with a set of tools and training to conduct effective root cause analysis.
- Assists with the regulatory submissions made to FDA and all other regulatory agencies to obtain clinical approvals and respond to inquiries.
Key Requirements and Technology Experience:
- Bachelor's degree with additional 10 years of progressively responsible experience managing quality compliance/assurance functions. Masters’ degree may substitute for two years of experience.
- Comprehensive knowledge of FDA, ICH, EMEA regulations and guidelines
- Minimum five years in a quality management role with direct reports
- In-depth knowledge of 21 Code of Federal Regulation Parts 11, 312 and 820, and experience with Quality Management Systems
- Experience conducting training for quality assurance and/or regulatory affairs.
- Proficiency in Microsoft Word, Outlook, Excel and PowerPoint
- Travel may be required.
Our client is a leading Healthcare Industry, and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.
Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
