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KCAS Bio · 2 days ago

Director of Quality Assurance

Kansas City, MO

Full-time

Onsite

Director/Executive

10+ years exp

KCAS Bio is a fast-growing contract research organization (CRO) headquartered in Kansas City, pioneering the latest drug development in both human and animal health fields. The Director of Quality Assurance will manage QA departments, oversee regulatory inspections, and ensure compliance with health agency regulatory requirements while leading a team to achieve departmental goals.

BiotechnologyPharmaceutical

Growth Opportunities

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

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

Qualification

Quality AssuranceRegulatory ComplianceCRO ExperienceBudget ManagementComputer ProficiencyPerformance EvaluationTrainingDevelopmentAudit ManagementSOP DevelopmentLeadership Skills

Required

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

Benefits

Company sponsored events like food trucks, family days and spirit days

KCAS University

Stock ownership program

Access to the latest technology

Paid time off to volunteer

Company

KCAS Bio

KCAS Bio is a top-tier contract research organization (CRO) that has 45 years of experience with both large pharma and biotech sponsors, providing comprehensive bioanalytical drug development services from early discovery through registration.

Founded in 1979

Shawnee, Kansas, USA

201-500 employees