Performing critical work that impacts our industry and our world's health while problem solving and innovating in the field - that is what the Director of Quality Assurance at KCAS Bio gets to do every day. If that gets you excited too, then maybe working as the Director of Quality Assurance is the role for you.

When you work as a Director of Quality Assurance at KCAS Bio, you have the opportunity to further our mission at the core by managing one or more QA departments or groups staffed by professional employees performing quality assurance functions and interacting with executive management, clients, and regulatory agencies as needed regarding quality systems, audits, and inspections.

You will be responsible for maintaining a high-level of professional expertise and leading regulatory inspections during FDA and critical client audits, overseeing the quality management system maintained at KCAS Bio, and providing expertise and guidance to all departments for interpreting and implementing health agency regulatory requirements.

While managing these responsibilities, you will also oversee the quality management system currently supported at KCAS Bio, meet department goals and objectives, and serve as a member of the Senior Leadership Team.

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 required
• 3 to 5 years of GLP-regulated experience is preferred. GCP or GCLP is also accepted.
• 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

(Please note this is a representative summary of responsibilities, not a comprehensive or exclusive list of the duties to be performed in any position. Employees must follow instructions and perform additional duties as requested.)