FierceBiotech and FiercePharma Jobs
Director of Clinical - Core Logic, Inc.
Jan 09
Location: US/UK/Ireland, Categories: Clinical
Website: http://corelogicinc.com
Position Description
Director of Quality
Confidential mid-sized pharmaceutical company is looking for an experienced Director of Quality.
Responsibilities:
1. Develop, implement, manage, audit and maintain GXP quality systems to support commercial and development activities.
2. Coordinate and perform all vendor qualification and compliance audits.
3. Perform lot release activities, including lot file compliance review.
4. Provide oversight for Quality Control activities performed by contract testing laboratories.
5. Develop, manage and maintain a GXP compliant document control system
6. Ensures that cGMP requirements and quality standards are recognized, understood and maintained across the Company.
7. Ensures in-process and finished products and processes conform to in-house policies and procedures as well as other applicable regulations and guidelines.
8. Budgetary and managerial responsibility for Quality Assurance and Quality Control
9. Works across all disciplines (e.g. manufacturing, clinical, R&D, etc.) to ensure that the Company maintains a state of readiness for inspection by regulatory agencies.
10. Keeps abreast of changes to quality regulations and guidelines, advising the management team of any business implications of these changes. Leads, manages and ensures proper training to any relevant change management programs throughout the company.
11. Participates in corporate development of methods, techniques, and evaluation criteria for projects, programs, and people.
12. Represents QA at management, project, and review meetings.
Requirements:
• Degree (advanced degree preferred) in biochemistry or relevant scientific discipline.
• Quality professional with 10+ years of hands on experience with increasing responsibility in a QA function.Prior responsibility for Quality Control.
• Significant hands on experience in an early stage (pre-IND to Phase 1/2) biopharmaceutical company.
• Hands on experience implementing quality systems in a GXP environment, and direct experience with FDA and other health authority inspections.
• Extensive knowledge of US GXP compliance regulations and industry practices, as well as EU GMP requirements.
• Ability to critically evaluate and troubleshoot complex problems is essential.
• Strong hands on leadership and management skills.
• Ability to effectively participate on multi-disciplinary teams.
• Ability to absorb, digest and relate detailed scientific, quality, and regulatory information
• Approximately 25% global travel required.
