What are the responsibilities and job description for the Site Quality Director position at Element Staffing Services?
Job Title : Site Quality Director
Job Description : Element Staffing is recruiting for a Site Quality Director for a pharmaceutical company in Houston, TX. The Site Quality Directory will serve as the site’s quality head and will ensure regulatory compliance for 21 CFR 210 and 211 Current Good Manufacturing Practice in Manufacturing, Processing, Packaging of Drugs, 21 CFR 4 Regulation of Combined Products. They will also oversee Quality Compliance, Quality Operations and Quality Control functions. This individual will perform job functions in accordance with all applicable Standard Operating Procedures (SOP), federal and state laws, Occupational Safety and Health Administration (OSHA) guidelines, health authority regulations, and departmental processes.
Duties / Responsibilities / Qualifications :
- Serve as the site’s Management Representative to authorize quality system and quality management changes.
- Ensures the quality system requirements are effectively established and maintained, reports the performance of the quality system to execute Quality Management.
- Provides organizational leadership and management oversight to the Quality department.
- Serve as the site’s Quality representative host for health authority / regulatory agency audits and inspections.
- Ensure the compliance to Global Quality policies.
- Coach, develop and identify staffing needs for the quality department.
- Oversee the sites cGMP training, stability and validation programs.
- Manage off-site contract manufactured products and CDMO quality business relations.
- Prepare and administer department budget.
- Must possess compliance auditing experience.
- Experience in the pharmaceutical industry within a cGMP environment is required.
- Perform other duties as assigned.
Additional Information :
