Principal Quality Assurance Associate at PHARPOINT RESEARCH INC – Durham, North Carolina

BASIC SUMMARY:

Provides technical leadership of quality assurance duties at PharPoint Research including project and non-project activities performed. Responsible for leading various areas of Quality Assurance including but not limited to CAPA Management, Vendor oversight, Computer Systems Validation, and Quality Audits. Leads complex quality initiatives, supports inspection readiness, and partners cross-functionally to ensure regulatory compliance and quality system effectiveness.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Provide expert input as it relates to company and departmental QA strategy and oversight.
• Triage, Investigate, Track and Coordinate resolution of Quality Events, Deviations, CAPAs and audit responses.
• Provide oversight of vendors to independently manage compliance with applicable regulations, SOPs, Study Plans, and quality agreements, including participation in vendor qualification and audit activities.
• Generate, review and implement SOPs and associated training.
• Lead and support computer system validation activities, including validation planning, documentation review, change impact assessment, and periodic review, to independently manage ongoing compliance.
• Apply risk-based thinking to quality activities, including identification, evaluation, mitigation, and ongoing monitoring of risks impacting clinical research and regulatory compliance.
• Create, maintain and review personnel training requirements and documentation.
• Develop and execute external and internal audit plans and processes.
• Coordinate and host sponsor audits; coordinate and implement responses to audit observations.
• Coordinate and assist in regulatory inspections; coordinate and implement responses to inspection findings/observations.
• Provide support and adhere to all aspects of PharPoint’s Quality System.
• Lead and support compliance with PharPoint’s data integrity and business ethics requirements.
• Maintain current knowledge of applicable industry regulations and guidance and proactively monitor new or revised requirements that impact clinical research and quality practices.
• Perform all other related duties as assigned.

QUALIFICATIONS:

• Education: Bachelor’s degree (B.A./B.S.) or equivalent in a scientific, management, or related discipline.
• Experience: Minimum 5-8 years of experience in quality assurance, quality systems, quality engineering, continuous improvement/ operational excellence, quality control, and/or validation.
• Demonstrated experience serving as a subject matter expert or lead contributor on complex quality initiatives.
• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
• Certification/Licensure: None.
• Other: Expert knowledge and understanding of ICH Guidelines for Good Clinical Practice, Title 21 of the Code of Federal Regulations, and good industry practices involving Quality. Knowledgeable expert in industry regulations and standards. Demonstrated professional presentation capabilities. Ability to read, write, speak and understand English required.

PHYSICAL DEMANDS:

• While performing the duties of this job, the employee is regularly required to talk, hear, and type/work at a computer.
• Specific vision abilities required by this job include close vision and the ability to adjust focus.

WORK ENVIRONMENT:

• General office working conditions, the noise level in the work environment is usually quiet.
• On-site 3-5 days/ week.

COMMENTS:

• This position requires occasional domestic/international travel.
• Must have a valid driver’s license with no limitations on driving availability.