Director, Quality and Compliance

Job Description

Job Description

Education

Bachelor’s degree in biology, biochemistry or related scientific field required

Summary Statement

The Director of Quality and Compliance reports to the Chief Quality and Compliance Officer and provides onsite support to the quality and 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.

Responsibilities: 

• Oversee quality system requirements to ensure the organization complies 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 
• Works with Associate Director, Quality and Compliance to ensure smooth daily operations within the QA department.
• Works with departmental directors to apply for relevant accreditations in the industry
• Maintains organization’s existing and future accreditations and certifications
• Provides training across the organization regarding applicable quality and regulatory issues
• Promotes quality achievement and performance improvement throughout the organization
• Enforces QA compliance objectives and ensures that targets are achieved
• Other duties as assigned

Knowledge, Skills and Experience:

• Certified Quality Auditor or other quality certification required
• Minimum of 10 years’ experience in Biopharmaceutical quality assurance with practical knowledge in quality systems, FDA, cGMPs, cGTPs, cGLPs and ATMP regulations
• At least 5 years’ direct QA experience in cell and gene therapy or biologics manufacturing.
• Prior experience with obtaining and maintaining FACT accreditation required
• Strong leadership ability, mentoring skills, and demonstrated ability to guide, train and provide constructive feedback to staff
• Strong commitment to quality practices
• Prior experience hosting regulatory inspections and providing oversite for cleanroom environments
• Strong background in aseptic processing and environmental monitoring data analysis
• Experience with autologous and allogeneic donor workflows
• Excellent organizational skills, attention to detail, ability to multi-task effectively and customer service skills 
• 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

Physical Demands

This position is basically sedentary with some walking, standing, stooping and lifting required.  Occasional lifting of objects weighing in excess of 20 pounds.  Travel may also be required.

This job description is not intended to be all inclusive.  Duties and/or responsibilities may be added or deleted as management requires to meet the ongoing needs of the organization.