What are the responsibilities and job description for the Senior Compliance Specialist position at Kelly Science, Engineering, Technology & Telecom?
Lead Compliance Officer- Permanent Position
Position Overview
The Lead Compliance Officer is responsible for ensuring that all operations align with regulatory frameworks set forth by the FDA and other applicable authorities.
Compliance Program Development & Oversight
- Develop, implement, and maintain compliance programs focused on cGMP operations.
- Conduct regular assessments and audits of internal departments and 3rd-party providers (e.g., suppliers, manufacturers, contract laboratories) to ensure regulatory adherence.
- Analyze regulatory developments and industry trends, providing actionable recommendations to enhance compliance strategy.
- Provide companywide notifications of updates to regulations or guidance affecting 503B outsourcing facility operations.
Regulatory Liaison & Reporting
- Assist with responses to regulatory agencies, inspections, and inquiries.
- Ensure timely and accurate documentation, reporting, and information transfer.
- Maintain accurate records of manufacturing processes to demonstrate compliance.
Training & Risk Management
- Lead the development and delivery of compliance training programs for employees.
- Collaborate with departments such as Legal, Quality, and R&D to address compliance issues and implement risk mitigation strategies.
- Perform internal audits of the Quality Management System (QMS) to ensure adherence to regulations and company policies.
- Drive corrective and preventive actions (CAPA) to address compliance-related issues.
Quality System Enhancement
- Collaborate with Quality Assurance and other departments to enhance the overall QMS. Lead initiatives to improve compliance, product quality, and operational efficiency.
Required Education and Experience
- Minimum of 8 years of experience in pharmaceutical, analytical testing, or related scientific fields.
- Minimum of 3 years of experience in pharmaceutical compliance or quality assurance.
- Bachelor’s degree in Biological Science, Chemistry, Biomedical Engineering, or a related field preferred.
- Familiarity with GxP, FDA, ICH, OSHA requirements, and 21 CFR Part 11.
- Proficiency in Microsoft Office (Word, Excel, etc.).
Salary : $80,000 - $95,000