Local Contact Person, Pharmacovigilance and Regulatory Affairs
ERGOMED
Director, Quality Assurance
KCAS Bioanalytical & Biomarker Services
full-time
Posted on:
Origin: • 🇺🇸 United States • Kansas
Visit company websiteJob Level
Lead
About the role
- 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
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 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
