Type of role: FTE, Full time Salary: plus bonus and equity
Our start-up Biotech client is seeking an Associate Director / Director Quality Assurance to join their growing company. Ideal candidate will be a hands-on Director who brings broad QA experience in the biologics industry.
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