Head of Quality Assurance, Clinical Research
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Job Description
Head of Quality Assurance overseeing SOPs, audits, inspections, and regulatory compliance. Supporting Tekton Research’s clinical trials and continuous quality improvement programs.
Responsibilities:
- Review, revise, and manage company SOPs, processes, and policies annually
- Identify process gaps and implement improvements
- Liaise with Corporate Operations on employee training requirements and documentation
- Create, maintain, and enforce Quality Assurance Plans for all company departments
- Lead and/or participate in critical projects supporting continuous quality improvements
- Manage the scheduling, performance, reporting, and follow-up of internal QA audits
- Lead and support sites during regulatory agency inspections and inquiries
- Develop and provide regular QA metrics reporting to leadership
- Assess QA growth and development needs based on company goals
- Provide guidance, interpretation, support, training, and input to development groups regarding regulations, guidelines, corporate standards, and policies
- Manage documentation, reporting, and closure of significant compliance issues
- Manage QA staff, including planning, assigning, and directing work, conducting evaluations, and guiding professional development
- Maintain current knowledge of industry trends, standards, and policies, including FDA, GCP, and EU requirements
- Perform other duties as assigned
- Report to the COO
Requirements:
- Bachelor and/or Master’s degree in a scientific or healthcare-related field
- 5-7 years Quality Assurance experience in pharmaceuticals, CRO, and/or site network
- 5-7 years of Management experience
- Demonstrated experience scheduling, planning and hosting regulatory inspections as well as internal/external audits
- QA leadership experience in highly regulated environments
- Experience developing teams and departments within medium-large organizations
- Comprehensive, current knowledge of clinical research requirements, processes and best practices
- Good Clinical Practice (GCP) certification/training every 3 years
- Maintain medical license(s), certifications, etc. as applicable
- Ability to travel up to 25%
- Able to sit for prolonged periods and work on a computer
- Must be able to lift up to 15 pounds at times
Benefits:
- Competitive compensation
- Comprehensive benefits
- Opportunities for professional growth
- Supportive and fast-paced research environment
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