Manager, R&D Quality Assurance- GCP

The Manager, R&D Quality Assurance- GCP will be responsible for managing Quality Assurance systems, processes and conducting internal and external audits and reviews, training, and reporting according to KK standards.

Requirements

• Bachelor’s degree in Life Science or closely related scientific discipline (e.g., Pharmacy, Chemistry, Microbiology, Biology, or Pharmaceutical Sciences) required
• Minimum three (3) experience in drug development in GCP/GLP Quality Assurance, including hands-on experience in auditing, CAPA management, and deviation review.
• Demonstrated knowledge of global regulatory requirements, including EMA, FDA, MHRA, ICH, and other applicable standards, with proven ability to interpret and apply them in operational settings.
• Experience supporting Health Authority inspections, including preparation, participation, and follow-up actions.
• Proven track record in developing and implementing risk-based audit plans, SOPs, and quality systems, with experience in quality document management.
• Experience in training and mentoring staff on GCP/GLP compliance and fostering a culture of quality.
• Exposure to global, cross-functional collaboration with clinical, regulatory, and operational teams on QA-related matters.
• Prior involvement in vendor/CRO management, clinical site audits, and quality agreement development is highly desirable.

Benefits

• 401K with company match
• Annual Bonus Program (Sales Bonus for Sales Jobs)
• Generous PTO and Holiday Schedule
• Healthcare Benefits
• HSA & FSA Programs
• Well-Being and Work/Life Programs
• Life & Disability Insurance
• Concierge Services
• Long Term Incentive Program
• Pet Insurance
• Tuition Assistance
• Employee Referral Awards