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Mgr. QA & Regulatory Compliance
Education and/or Special Training Bachelor's Degree in scientific or other relevant field;
Master's Degree or equivalent additional coursework preferred
Internal or lead auditor certification (CQA/CQE)
Job Description Manage the division's internal and external audit functions to ensure compliance to regulatory and statutory requirements. Coordinate activities of Third Party visits (Notified Body, FDA). Coordinate Management Review Activities. Ensure overall QMS system compliance with applicable regulatory and statutory requirements.
ESSENTIAL DUTIES & RESPONSIBILITIES:
Manage the internal and external audit functions to ensure compliance to regulatory and statutory requirements
Coordinate activities of Third Party visits (Notified Body, FDA) and associated corrective action activities
Coordinate Management Review activities
Perform annual performance reviews and recommend appropriate salary action
Ensure overall QMS system compliance with applicable regulatory and statutory requirements
Perform internal quality assurance audits to 21CFR 820, ISO 9001:2000, ISO 13485:2003, 93/42/EEC and other applicable Standards to ensure corporate and regulatory compliance
Ensure effective closure, by working with auditees to ensure comprehension, development, and execution of corrective/preventive action with regards to any nonconformities cited during audits
Develop and conduct effective training programs on related QA topics
Conduct and support benchmarking activities
Identify areas of opportunity and support continual improvement of the Quality Management System
Identify, develop, and report QMS metrics
Participate in continuous (breakthrough) improvement activity and process re-engineering projects in support of divisions continual improvement initiatives
Qualifications/Work Experience
Demonstrated experience in developing quality management systems; design and development of training programs/courses; lean documentation; and Six Sigma methodology
Demonstrated auditing experience in medical device or other regulated manufacturing environment (biotech, pharma, military/space)
Applied understanding of CGMPs, ISO 9001, ISO 13485, and CMDR
Demonstrated ability to effectively advocate a strategic quality systems approach and lead the organization to compliance
Demonstrated ability to work effectively with various work groups to assure conformance to regulatory requirements, internal processes, and policies
Demonstrated leadership ability and experience
Demonstrated project management experience
Demonstrated PC proficiency
Demonstrated organizational and written/verbal communication skills
Demonstrated ability to self-motivate
Demonstrated ability to effectively work with others in various coordinate disciplines and on multi-national teams
Demonstrated ability to prioritize tasks in a deadline-driven environment
Percent Travel Required 5%
contact
jamie@pharmasearchpartners.com
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Position Type:
Employee
Ref Code: jr006 |
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