Director of Quality Assurance

About the role

The Director of Quality Assurance at KCAS Bio performs critical work impacting the industry and global health. This role involves managing quality assurance functions, interacting with executives, clients, and regulatory agencies, and ensuring compliance with health agency regulations.

Responsibilities

• 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
• 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
• Afford coordination of 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, remain up-to-date with current technologies, and comply 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
• 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
• 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

Requirements

• 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
• 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

Qualifications

• Experience in a CRO or pharmaceutical company is required
• 3 to 5 years of GLP-regulated experience 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

Skills

• Strong leadership skills
• Excellent communication and interpersonal skills
• Ability to manage multiple priorities and deadlines
• Knowledge of regulatory requirements and industry standards
• Experience with quality management systems
• Ability to lead and mentor a team
• Strong analytical and problem-solving skills

Benefits

At KCAS Bio, you will enjoy a range of benefits including:

• Company-sponsored events like food trucks, family days, and spirit days
• KCAS University for career development
• Stock ownership program
• Access to the latest technology
• Paid time off to volunteer in the community

Pay

Details on pay will be provided upon interview.

Schedule

Details on schedule will be provided upon interview.