Director of Quality Assurance

In this role, we will rely on you to:

• Assure Quality systems are designed and performing to meet industry, regulatory and executive management requirements
• Initiate employee hire, promotion, discharge, or transfer
• Participate in the selection process for subordinate personnel including determining recruiting criteria, interviewing, and performing reference checks
• Perform annual performance evaluations for direct reports
• Require and monitor training for subordinates to develop them to their potential
• Effectively use delegation to develop subordinates
• Perform career planning for subordinates
• Provide encouragement and positive reinforcement to subordinates; require subordinate leadership staff to do the same
• Participate in the development of short and long-range goals and objectives, implement and attain short and long-range goals and objectives, and assure that year-end goals are attained
• Assure that all departmental management staff are working in concert with each other
• Coordinate activities of the department with related activities of other departments, to ensure efficiency and economy
• Understand, communicate and cascade communication from Executive management
• Be knowledgeable of site departmental budget and will monitor and analyze cost against budget
• Overall responsibility for the Quality Assurance operation, compliance and site department goals including budget management
• Interact with clients relating to quality audits, respond to client audit reports, and understand client needs/expectations
• Complete client QA questionnaires and respective QA-assigned sections of RFIs
• Forecast, recommend and justify strategies to accommodate growth when needed (space, equipment, staffing)
• Establish policies and procedures to ensure that QA operations maintain a high level of QA expertise, remains abreast of current technologies and complies with related regulatory policies, OSHA and company SOPs/policies
• Audit reports, data, internal processes, computer system validations, facility, and procedures to support management to improve data integrity, reduce error rates, efficiency, and maintain compliance
• Manage internal auditing program including planning, conduct and reporting of audits
• Conduct annual management review of the quality system
• Manage digital quality systems, including eQMS administration, archiving, and related scanning
• Ensure appropriate validation of methodology and instrumentation per regulatory requirement/industry expectation
• Oversee CAPA system to ensure effective continuous improvement. Designates a CAPA
• Coordinator and back-up within the department
• Perform and track vendor quality assessments
• Review/update SOPs to reflect current practice and regulatory requirements
• Maintain expert knowledge of bioanalytical scientific trends as well as regulatory requirements
• Perform complex quality assignments with understanding of underlying scientific principles
• Recommend and institute systems and programs to improve safety, work quality, cost saving and productivity
• Effectively interface with various functional units, groups or departments in the company

To qualify specifically for this role, you will have:

• Bachelor’s degree in a related field
• Director-level experience preferred
• 10 years industry-related experience, including 2 years supervisory experience
• Experience in a CRO or pharmaceutical company is preferred
• Broad knowledge of regulatory requirements applicable to areas managed
• Extensive knowledge of processes applicable to subordinate groups
• Awareness of industry trends related to areas managed
• Computer proficiency
• Perform all aspects of the job in a way that supports the company brand and the company mission, vision, and values