Job Description

Performing critical work that impacts our industry and our world’s health while problem solving and innovating in the field – that is what we get to do every day at KCAS Bio. If that gets you excited too, then maybe working at KCAS Bio is for you.

When you work as a Quality Assurance Manager at KCAS, you get to further our mission as the core of KCAS by managing teams in our Quality department that ensure quality and compliance within applicable regulatory requirements. This will include interacting with clients and regulatory agencies as needed, document review, audits, inspections, and consulting on quality and compliance issues.

In this role, we will rely on you to:

• Performs management duties for subordinates, including but not limited to, assigning/scheduling work, assisting in recruiting efforts, development and attainment of goals, annual reviews, training and development, delegation, timesheet, and time off request approvals
• Works in concert with departmental management and leadership
• Understands, communicates, and cascades communication from the department’s Director
• Is knowledgeable of departmental budget and executes performance to meet budget
• Performs quality review and approval of documents, data, protocols, and/or reports
• Completes facility and process audits
• Reviews laboratory deviations and investigations, and ensures respective follow-up occurs to meet expected turn-around times
• Maintains accurate quality assurance files, records, and databases, and may perform analysis and trending
• Provides consultation on quality and compliance topics in areas of expertise as well as quality improvement initiatives as needed
• Ensures audit responses have adequate follow-up to meet expected turn-around times
• Provides training in complex quality and compliance topics
• Maintains open and clear communication with Operations and related support teams to ensure high data and report integrity, including necessary feedback, utilizing all forms of communication modes (face-to-face, phone and email). Expects same of subordinates
• Revises and creates written quality SOPs, documents and/or reports as needed
• Assists with Quality System enhancement activities to drive the initiative forward; ensures team is also engaged with the enhancement to meet expected timelines
• Serves as client quality liaison and/or quality host of client audits; ensures responses to client audits are provided per required timelines
• Domestic and international travel may occasionally be required
• Performs vendor qualification activities, as needed
• Back-up to head of Quality

To qualify specifically for this role, you will have:

• Bachelor’s degree
• CRO (Contract Research Organization), pharmaceutical GMP, FDA or OECD GLP and/or GCLP experience preferred
• 6 years industry related experience in quality assurance
• Broad knowledge of regulatory requirements, applicable to areas managed
• Extensive knowledge of processes applicable to subordinate employees
• Awareness of industry trends related to areas managed
• Previous management experience, with proven effective leadership skills

(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.)

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 being part of innovative work.

WHAT YOU’LL GET

Our benefits include, and extend beyond, the traditional package. At KCAS Bio, you will enjoy company sponsored events like food trucks, family days and spirit days. You will grow in your career with KCAS University. You will be able to connect with like-minded employees to further KCAS Bio's approach to key areas such as wellness, inclusion, and community outreach. You will engage as an owner in our stock ownership program. You will have access to the latest technology. And you will be able to invest in the community with paid time off to volunteer.

WHO WE ARE

We are a fast-growing contract research organization (CRO) headquartered in Kansas City, pioneering the latest drug development in both human and animal health fields. Demand for our expertise is growing and so is our need for great people to work in nimble, empowered teams committed to one another’s growth. At KCAS Bio, we advance both great science AND great people.

KCAS Bio is proud to be an Equal Opportunity Employer. Among other things, 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 based on internal processes that enable us to hire the right candidates consistent with the appropriate U.S. Immigration framework; and (3) we work with and provide reasonable accommodations to individuals with disabilities and for sincerely held religious beliefs, observances, and practices. Anyone who needs reasonable accommodation may send an email to kcasrecruiting@kcasbio.com or call 913-248-3000 (for TTY assistance call 711) and ask for Human Resources.

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