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



The Vice President of Quality is responsible for oversight of the Quality Assurance (QA), Quality Control (QC), Quality Systems, Product Quality, Validation and Regulatory Compliance groups in support of the Seattle site at AGC Biologics. The VP works closely with the site leadership team to develop and execute the corporate goals and objectives for Seattle. The VP is responsible for leading Seattle as a development and commercial manufacturing operations as the site goes through significant expansion driven by the number of PPQ projects in its portfolio. The VP is responsible for oversight of the site quality systems and ensuring overall GMP compliance with current regulatory requirements and guidelines.


Key Responsibilities:

•    Provide leadership and direction to the Seattle Quality organization.
•    Serve as an active member of the Global Quality Leadership Team.
•    Serve as an active member of the Seattle site Leadership Team responsible for development and implementation of site strategy and goals.
•    Mentor and develop staff members within the organization.
•    The VP of Quality holds final accountability for and decision making on the matters relating to GMP compliance for the site.
•    Responsible for setting the overall strategies, tactics and directions of the site QA, QC, Quality Systems, Product Quality, Validation and Regulatory Compliance departments in alignment with the AGC Biologics QMS. Decisions are focused on key strategic and operational matters that have significant, direction-setting impact on the Seattle site.
•    Responsible for setting and aligning goals and objectives for the QA, QC, Quality Systems, Product Quality, Validation and Regulatory       Compliance departments with the overall corporate goals and objectives. Ensuring that the site goals and objectives are accomplished. Failure to effectively execute responsibilities may negatively impact critical, site-wide goals, objectives, and outcomes. In addition, there may be legal and regulatory consequences.
•    Accountable for development of QA, QC, Quality Systems, Product Quality, Validation and Regulatory Compliance departmental budgets that support the corporate and departmental goals and objectives. Responsible for controlling the budget during the fiscal year.
•    Develops and drives Global Quality cross-site initiatives.
•    Provides advice and counsel to the site Leadership Team on regulatory GMP compliance issues.
•    Serves as the principal site spokesperson with customers, regulatory agencies, etc., on matters of regulatory GMP compliance.
•    Requires the ability to negotiate and achieve alignment with executive management and external audiences at the highest levels, including regulatory agencies.
•    Works with other AGC Biologics sites to align and integrate quality systems.
•    Other duties as assigned.


Knowledge, Skills, and Abilities:

•    Mentorship responsibility for Quality staff as well as peers
•    Responsible for oversight of Quality staff
•    Independently directs and controls the activities and outcomes of more than one major functional area, or a central, major corporate function with significant organization-wide impact
•    Typically has sole responsibility for planning and managing a sizeable, highly discretionary budget
•    Holds accountability for site adherence to all applicable quality regulations


Education and Experience:

•    Requires bachelor or advanced degree or equivalent combination of education and experience
•    20+ years of experience in biotech and/or pharmaceutical manufacturing
•    15+ years of experience in quality operations (QA, QC, Quality Systems) within biopharmaceutical and/or pharmaceutical industry
•    Strong working knowledge of Quality Systems (FDA QSIT and ICH Q10) and how those systems are implemented to meet FDA and EMA requirements
•    Experience supporting regulatory filings (e.g., INDs, BLAs, etc.) and leading product-related inspections for US and foreign regulatory agencies
•    Experience developing, implementing and executing strategic plans and objectives for organizations and departments
•    Exceptional customer interface skills are required
•    Ability to work hours necessary to support operations activities
•    Technical background in protein development is preferred


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.

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