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Job Summary |
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Director, Quality
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POSTED: Nov 03
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| Salary: |
Open |
Location: |
W. Los Angeles |
| Employer: |
California Cryobank, Inc. |
Type: |
Full Time - Experienced |
| Category: |
Biomedical - Quality |
Required Education: |
4 Year Degree
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Job Description |
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This position will develop, implement and maintain a comprehensive quality assurance/ quality control program in compliance with all standard operating procedures and regulatory/accrediting requirements.
The candidate should be a seasoned QA/QC professional with experience managing multiple locations, including at the Corporate level. The ideal candidate will have the proven ability to successfully tackle unique challenges that require superior interpersonal, problem-solving, and relevant technical skills within an atypical business environment. In addition, experience mapping business processes and using process mapping tools to ensure that all regulatory requirements are met is a plus.
Primary responsibilities include the following: • Oversees Company's Quality Program • Ensures compliance with regulatory/accrediting agency standards and current cGMP • Training, including identifying training needs and assuring quality control of training files • Responsible for ensuring compliance with regulations and standards set forth by federal, state, local, regulatory and accreditation agencies • Ensures that processes comply with all relevant quality standards and regulations; continually reviews all relevant policies/procedures and implements change as necessary • Conducts internal and external audits to document compliance; recommends and implements corrective action when necessary • Acts as the Company's liaison to regulatory/accrediting agencies; develops and coordinates the necessary regulatory responses and agency interaction • Corrective and Preventive Action (CAPA), Nonconformance Report (NCR) and Complaint Management Report (CMR) Systems: • Maintains and coordinates investigations • Assists in resolving quality concerns and issues • Provides constructive and relentless guidance in finding solutions for improvement • Provides ongoing communication of CAPA, NCR and CMR status • Develops process improvement measures to ensure continuous quality and business improvement • Establishes an effective system for ensuring that all production records are in compliance and authorizes cells for release that have met the established criteria • Maintain active role with all regulatory societies (including AATB, FDA, ASRM, etc) • Other duties and projects as required
| NOTES: |
Local Residents Preferred (No Relo)
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Requirements |
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• Bachelor of Science degree • Experience in managing regulatory affairs and/or quality control; experience with cGMP, FDA and AATB standards desired • Experience with process mapping and business process re-design (preferred, not mandatory) • Experience with FDA auditors (preferred, not mandatory) • Proven ability to manage internal teams • Experience in integrating regulatory requirements into ERP/MIS systems (preferred, not mandatory) • MS Office proficiency - Strong computer skills, including but not limited to, Windows environment (Word, Excel, Access, Power Point – Intermediate to Advanced skills) required. • Excellent written/verbal communication and interpersonal skills • Outstanding problem-solving and organizational skills • Strong attention to detail • Ability to work independently • Ability to concurrently manage multiple projects
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