Director of Quality Assurance
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Job Location:
Kansas City, KS - USA
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Performing critical work that impacts our industry and our worlds 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:
- Bachelors 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
(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 YOULL 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 will grow in your career with KCAS will be able to connect with like-minded employees to further KCAS Bios approach to key areas such as wellness inclusion and community 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.
Learn more about the 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 both human and animal health for our expertise is growing and so is our need for great people to work in nimble empowered teams committed to one anothers 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 emailprotectedor call (for TTY assistance call 711) and ask for Human Resources.
IND123
We may use artificial intelligence (AI) tools to support parts of the hiring process such as reviewing applications analyzing resumes or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed please contact us.
Required Experience:
Director
Key Skills
- Quality Assurance
- FDA Regulations
- ISO 9001
- Root cause Analysis
- Biotechnology
- Clinical Trials
- Quality Systems
- Food Processing
- Quality Control
- Quality Management
- cGMP
- HACCP
About Company
As a full-service bioanalytical CRO and biomarker partner, KCAS Bio helps accelerate drug development in the pharma and biopharma industries with large and small molecule bioanalysis.
