🚀 Director, Quality Assurance

Overview

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 excites you, consider this role.

As Director of Quality Assurance, you will manage one or more QA departments or groups, interact with executive management, clients, and regulatory agencies as needed regarding quality systems, audits, and inspections, and lead regulatory inspections during FDA and client audits. You will oversee the quality management system (QMS) and provide expertise to interpret and implement health agency regulatory requirements, while meeting department goals and serving as a member of the Senior Leadership Team.

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 recruiting criteria, interviewing, and reference checks
• Perform annual performance evaluations for direct reports
• Require and monitor subordinates training to develop their potential
• Use delegation to develop subordinates
• Perform career planning for subordinates
• Provide encouragement and positive reinforcement to subordinates; require leadership staff to do the same
• Develop and attain short and long-range goals; ensure year-end goals are met
• Coordinate departmental activities with related departments to ensure efficiency
• Understand, communicate, and cascade information from Executive management
• Monitor site departmental budget and cost against budget
• Oversee Quality Assurance operations, compliance, and site department goals including budget management
• Interact with clients regarding quality audits, respond to audit reports, and understand client needs/expectations
• Complete client QA questionnaires and relevant sections of RFIs
• Forecast and justify strategies to accommodate growth (space, equipment, staffing)
• Establish policies and procedures to maintain high QA expertise and regulatory compliance
• Audit reports, data, processes, computer system validations, facility, and procedures to improve data integrity and compliance
• Manage internal auditing program (planning, conduct, reporting)
• Conduct annual management review of the quality system
• Manage digital quality systems, including eQMS administration and archiving
• Ensure validation of methodology and instrumentation per regulatory requirements
• Oversee CAPA system for continuous improvement
• Coordinate and provide 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 trends and regulatory requirements
• Perform complex quality assignments with scientific understanding
• Recommend and implement systems to improve safety, quality, cost savings, and productivity
• Interface effectively with various functional units and departments

Qualifications

• Bachelor’s degree in a related field
• Director-level experience preferred
• 10 years of 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 mission, vision, and values

(Note: This is a representative summary of responsibilities; not a comprehensive or exclusive list of duties. Employees may be asked to perform additional duties as required.)

WHO YOU ARE

You will thrive at KCAS Bio if you enjoy a relational environment, are purpose- and values-driven, embrace constant development and supportive leadership, and enjoy innovative work.

WHAT YOU’LL GET

Our benefits include, and extend beyond, the traditional package. KCAS Bio offers company-sponsored events, opportunities for career growth, a stock ownership program, access to the latest technology, and paid time off to volunteer. Learn more about Benefits at KCAS Bio.

WHO WE ARE

We are a fast-growing contract research organization (CRO) headquartered in Kansas City, pioneering the latest drug development in human and animal health. We value great science and great people.

KCAS Bio is proud to be an Equal Opportunity Employer. We provide equal employment opportunities without regard to race, color, religion, national origin, ancestry, marital status, veteran status, age, disability, pregnancy, genetic information, sex, sexual orientation, gender identity, or any other legally protected category. We recruit qualified candidates without regard to citizenship status consistent with U.S. Immigration framework and provide reasonable accommodations to individuals with disabilities and for sincerely held religious beliefs, observances, and practices. For accommodations, contact Human Resources at or .

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