Posted on Apr 5, 2021 by AGC Biologics
The Vice President of Quality is responsible for oversight of the Quality Assurance (QA), Quality Control (QC), Quality Systems, Validation and Regulatory Compliance groups in support of the Colorado site at AGC Biologics. The VP works closely with the site leadership team to develop and execute the corporate goals and objectives for Colorado. The initial focus will be to get the facility operational and integrate it into the AGC Biologics QMS. The VP is responsible for leading Colorado as a late-stage and commercial manufacturing operations. The VP is responsible for oversight of the site quality systems and ensuring overall GMP compliance with current regulatory requirements and guidelines.
Provide leadership and direction to the Colorado Quality organization.
Serve as an active member of the Global Quality Leadership Team.
Serve as an active member of the Colorado site Leadership Team responsible for development and setting 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, Validation and Regulatory Compliance departments in alignment with the AGC Biologics QMS. Decisions are focused on key strategic and operational maters that have significant, direction-setting impact on the Colorado site.
Responsible for setting and aligning goals and objectives for the QA, QC, Quality Systems, 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, 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.
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
KNOWLEDGE, SKILLS & ABILITIES:
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 (eg, 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
Applicants must be authorized to work in the United States. If you are legally authorized to work in the United States now, or in the future without any form of sponsorship, we encourage you to apply.
Requires bachelor or advanced degree or equivalent combination of education and experience.
Equivalent education and experience may substitute for stated requirements