Job Description

• Develop and implement GXP including GMP quality systems in accordance with ICH, FDA, EMA and global competent authority regulations and industry guidance
• Review all GXP documents/reports especially as they relate to method development, validation activities and PPQ generation results
• Provide compliance oversight for internal and contracted external GXP activities
• Coordinate and implement audit plans and audit reports for all CROs, CDMOs, and GMP vendors and internal departments.
• Coordinate and perform virtual or on-site audits as needed
• Provide quality oversight for GMP CDMOs (including quality agreements) and manage GMP product batch record review and disposition.
• Lead and ensure inspection readiness activities for all internal and external entities
• Host GMP inspections. Follow up to any responses and CAPAs
• Develop, implement, and manage the quality management systems including vendor management, change control, product label review, risk management, GXP computer systems, deviation and CAPA systems
• Develop and implement overall GXP strategy, performance metrics, analytics, and reports
• Ensure and record periodic SOP trainings for all employees including onboarding FTEs and contractors in the GXP system as applicable

• Bachelor’s degree in biological sciences or related field with minimum of 10 years’ experience in a pharmaceutical setting.
• Proven, extensive knowledge of worldwide GXP regulatory requirements, industry practices, and ability to apply concepts. Experience with GMP regulations and current industry standards.
• Experience in designing and implementing quality systems and risk management tools
• Experience interacting with and managing CMOs for DS and DP especially biological products
• Experience leading/hosting US and international health authority inspections/interactions
• Excellent interpersonal, verbal, and written communication skills are critical in our collaborative work environment
• Must demonstrate high organizational, prioritization and management proficiencies
• Ability to deliver in a fast-paced, small company environment and tenacity to seamlessly adjust workload based upon changing priorities