Quality Systems Supervisor

Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.

Key Responsibilities

• Coordinate the Quality System Compliance team and its related activities
• Manage the Self-Inspection process
• Manage the GMP documentation on the digital electronic system TrackWise
• Oversee the periodic monitoring and analysis of quality KPIs
• Manage the CAPA Management process
• Manage the alignment of internal procedures with corporate policies
• Manage the risk management process and the risk register
• Manage the GMP paper documentations archive and their sending to customers
• Act as a subject matter expert during inspections by regulatory agencies, corporate teams, and clients and support in their preparing

Qualifications & Experience

• Master Degree in a scientific discipline (e.g., Biology, Chemistry, Biotechnology, Pharmacy)
• 5+ years of experience in a documentation control or quality system/assurance role within a GMP-regulated environment (pharmaceutical or biotechnology industry)
• Experience as a people leader
• Knowledge of GMP and Data Integrity standards
• Proficiency with Electronic Document Management Systems and Office Windows system
• Exceptional attention to detail and organizational skills
• Communication and interpersonal skills
• Professional working knowledge of English (both written and spoken)

AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement.

AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.