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Director, Quality Management Systems

AGC Biologics Seattle, WA
  • Posted: February 08, 2019
  • Full-Time

AGC Biologics is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. Because of our dedication to building and empowering our internal teams, AGC Biologics is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics.

We forge exceptionally strong partnerships with our clients, and we never lose sight of our pledge to deliver a reliable and compliant drug substance supply, Right, On time. For more information, visit www.agcbio.com. SUMMARY: AGC Biologics is currently looking for a Director to join the Quality Management Systems team.

The ideal candidate possesses strong understanding of GMP requirements and experience working in a fast-paced, dynamic environment. PRINCIPAL RESPONSIBILITIES: Manage and maintain GMP Quality System consistent with regulatory requirements and industry best practices Design and maintain Quality Systems for GMP Deviations, CAPA, Training, Periodic Change Management, Review and Document Management programs. Manage Quality System Reporting Develop and maintain Quality System Metrics Administer Quality Management Review program Ensure continuous improvement of Quality Systems Support Regulatory and Client Audits Proactively address GMP compliance concerns and resolve problems Work on complex problems that involve groups outside of QA as well as clients Partner with other departments/groups for corrections and problem solving Review and approve deviations and corrective actions Participate in GMP-related problem resolution Provides direct supervision and staff development Establish departmental goals and priorities, assign tasks and projects to staff Use best practices in training development and coaching Host and lead regulatory inspection and client audit readiness Maintain internal audit program Maintain supplier quality management program Manage and maintain GMP Quality System consistent with regulatory requirements and industry best practices Design and maintain Quality Systems for GMP Deviations, CAPA, Training, Periodic Change Management, Review and Document Management programs.

Manage Quality System Reporting Develop and maintain Quality System Metrics Administer Quality Management Review program Ensure continuous improvement of Quality Systems Support Regulatory and Client Audits Proactively address GMP compliance concerns and resolve problems Work on complex problems that involve groups outside of QA as well as clients Partner with other departments/groups for corrections and problem solving Review and approve deviations and corrective actions Participate in GMP-related problem resolution Provides direct supervision and staff development Establish departmental goals and priorities, assign tasks and projects to staff Use best practices in training development and coaching Host and lead regulatory inspection and client audit readiness Maintain internal audit program Maintain supplier quality management program KNOWLEDGE, SKILLS & ABILITIES: Strong knowledge of GMP and Regulatory Compliance as applicable to the Pharmaceutical/ Biotechnology Industry Ability to understand and apply GMP regulations as they relate to manufacturing, QC alalytical testing, and facility operations Strong interpersonal, written and oral communication skills Strong problem solving skills EDUCATION/EXPERIENCE: B.S. in chemistry or life sciences or equivalent experience 10 years of relevant experience in a pharmaceutical or FDA/GMP environment Direct Experience leading GMP Quality Systems development, implementation, and continuous improvement Experience hosting and leading client and Regulatory Inspections Management experience, including a demonstrated ability to effectively manage staff and multiple tasks utilizing organization and prioritization skills, driven to meet timelines, and results-orientated Experience in protein therapeutics manufacturing preferred KNOWLEDGE, SKILLS & ABILITIES: Strong knowledge of GMP and Regulatory Compliance as applicable to the Pharmaceutical/ Biotechnology Industry Ability to understand and apply GMP regulations as they relate to manufacturing, QC alalytical testing, and facility operations Strong interpersonal, written and oral communication skills Strong problem solving skills EDUCATION/EXPERIENCE: B.S. in chemistry or life sciences or equivalent experience 10 years of relevant experience in a pharmaceutical or FDA/GMP environment Direct Experience leading GMP Quality Systems development, implementation, and continuous improvement Experience hosting and leading client and Regulatory Inspections Management experience, including a demonstrated ability to effectively manage staff and multiple tasks utilizing organization and prioritization skills, driven to meet timelines, and results-orientated Experience in protein therapeutics manufacturing preferred AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement.

EOE

AGC Biologics

Address

Seattle, WA
USA

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