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Head of Quality Assurance – Clinical Research
Tekton Research. Review, revise, and manage company SOPs, processes, and policies annually .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Quality Assurance leadership within highly regulated environments, with a strong focus on compliance, regulatory inspections, and continuous quality improvement. Proficient in developing teams and managing QA processes in alignment with industry standards and best practices.
Highest-signal resume keywords
Quality Assurance LeadershipRegulatory Inspections ManagementGood Clinical Practice (GCP) CertificationClinical Research KnowledgeManagement Experience
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Quality Assurance ProcessesSOP ManagementInternal QA AuditsCompliance Issue ManagementQuality Metrics ReportingProcess ImprovementEmployee Training DocumentationRegulatory Agency LiaisonTeam DevelopmentProject Management
Soft Skills
LeadershipCommunicationTraining and SupportProblem SolvingCollaboration
Certifications & Qualifications
Good Clinical Practice (GCP) CertificationMedical License
Industry Keywords
PharmaceuticalsCROClinical ResearchFDA RegulationsEU RequirementsQuality Assurance PlansCompliance StandardsRegulatory GuidelinesInternal/External AuditsQuality Improvement
About the role
Key responsibilities & impact- Review, revise, and manage company SOPs, processes, and policies annually
- Identify gaps in processes and implement improvements
- Liaise with Corporate Operations on employee training requirements and documentation
- Create, maintain, and enforce Quality Assurance Plans for all departments
- Lead 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 on regulations, guidelines, corporate standards, and policies
- Manage documentation, reporting, and closure of significant compliance issues
- Manage QA staff, including planning, assigning, and directing work, evaluations, and professional development
- Maintain current knowledge of industry trends, standards, and policies, including FDA, GCP, and EU requirements
- Perform other duties as assigned
- Reports to the COO
Requirements
What you’ll need- 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
- 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
- Good Clinical Practice (GCP) certification/training every 3 years
- Maintain medical license(s), certifications, etc. as applicable
- Prolonged periods of sitting at a desk and working on a computer
- Must be able to lift up to 15 pounds at times
- Up to 25% travel
Benefits
Comp & perks- Competitive compensation
- Comprehensive benefits
- Opportunities for professional growth
- Supportive and fast-paced research environment