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Director of Quality Assurance and Regulatory Compliance

Quality Assurance

The Quality Assurance Manger and Regulatory Compliance Office oversees the quality assurance and regulatory compliance strategies of the organization. The position strives to ensure that the product or service the organization provides is fit for its purpose and meets customer expectations and regulatory standards and compliance.


Develops and implements policies and procedures for quality system requirements including a Quality Management Plan, to ensure that the organization is in compliance with federal (i.e. FDA) and state (i.e. Department of Health) regulatory requirements and standards promulgated by relevant accrediting bodies (i.e. WMDA, FACT, NMDP, AABB)
Keeps abreast of laws and regulations that may affect the organization’s policies, on an ongoing basis through industry bulletins, journals, meetings and seminars and ensures that the organization is in compliance
Works with departmental managers to apply for relevant accreditations in the industry
Maintains existing and future accreditations and certifications
Provides training to all organization staff on applicable quality and regulatory issues
Promotes quality achievement and performance improvement throughout the organization
Sets up QA compliance objectives and ensures that targets are achieved
Sets up and maintains controls and documentation
Other duties as assigned

Knowledge, Skills and Experience:
Background in quality systems, FDA, cGMPs, cGTPs, and cGLPs
At least 5 years’ experience in the field of quality assurance and compliance
Strong leadership ability, mentoring skills, and demonstrated ability to guide, train and provide constructive feedback to staff
Strong commitment to quality practices
Excellent organizational skills, attention to detail, ability to multi-task effectively and customer service

Effective, clear and concise oral and written English communication abilities
Knowledge of business principles relating to goal attainment
Knowledge of measurement / benchmarking techniques for continuous process improvement

Qualified candidates should email CV to