Job Description

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).

Our culture at AGC Biologics is defined by the six core values: Knowledge, Trust, Quality, Ingenuity, Accountability and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe.

AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit www.agcbio.com.  Want to keep posted about our growth and learn more about our company? Follow us on LinkedIn and give us a quick Like on Facebook!

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.