AGC Biologics
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: 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 sites (Boulder and Longmont) at AGC Biologics. The VP works closely with the site leadership teams to develop and execute the corporate goals and objectives for Boulder and Longmont. 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 development and commercial manufacturing operations for recombinant proteins and cell & gene therapies. The VP is responsible for oversight of the site quality systems and ensuring overall GMP compliance with current regulatory requirements and guidelines. Responsibilities 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 for Boulder and Longmont. 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 facilities at Boulder and Longmont. 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 sites. 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 at Boulder and Longmont. Serves as the principal spokesperson with customers, regulatory agencies, etc., on matters of regulatory GMP compliance for Boulder and Longmont. 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. Education Requires bachelor or advanced degree or equivalent combination of education and experience EXPERIENCE and Critical Skill Requirements 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, with significant leadership experience. 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 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 COMPENSATION RANGE: $ 228,960- $314,820 annually Fluctuations in the job market may necessitate adjustments to pay ranges. Final pay determinations will depend on various factors, including, but not limited to experience levels, knowledge, skills, and abilities. Benefits available to Team Members include subsidized insurance for the Team Member and designated dependents (medical, vision, dental, life and disability), eligibility to participate in the AGC Biologics 401(k) plan (including a generous matching contribution from the company and immediate vesting), vacation, sick time, and parental leave. Team Members are also eligible to receive a discretionary annual bonus commensurate to the level of the role. The payout is based on both the company’s performance and the Team Member’s performance. 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. About the company
AGC Biologics is a leading global Contract Development and Manufacturing Organization (CDMO), with a commitment to completing projects right, and on time. Notice
Talentify is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status. Talentify provides reasonable accommodations to qualified applicants with disabilities, including disabled veterans. Request assistance at accessibility@talentify.io or 407-000-0000. Federal law requires every new hire to complete Form I-9 and present proof of identity and U.S. work eligibility. An Automated Employment Decision Tool (AEDT) will score your job-related skills and responses. Bias-audit & data-use details: www.talentify.io/bias-audit-report . NYC applicants may request an alternative process or accommodation at aedt@talentify.io or 407-000-0000.
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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: 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 sites (Boulder and Longmont) at AGC Biologics. The VP works closely with the site leadership teams to develop and execute the corporate goals and objectives for Boulder and Longmont. 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 development and commercial manufacturing operations for recombinant proteins and cell & gene therapies. The VP is responsible for oversight of the site quality systems and ensuring overall GMP compliance with current regulatory requirements and guidelines. Responsibilities 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 for Boulder and Longmont. 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 facilities at Boulder and Longmont. 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 sites. 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 at Boulder and Longmont. Serves as the principal spokesperson with customers, regulatory agencies, etc., on matters of regulatory GMP compliance for Boulder and Longmont. 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. Education Requires bachelor or advanced degree or equivalent combination of education and experience EXPERIENCE and Critical Skill Requirements 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, with significant leadership experience. 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 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 COMPENSATION RANGE: $ 228,960- $314,820 annually Fluctuations in the job market may necessitate adjustments to pay ranges. Final pay determinations will depend on various factors, including, but not limited to experience levels, knowledge, skills, and abilities. Benefits available to Team Members include subsidized insurance for the Team Member and designated dependents (medical, vision, dental, life and disability), eligibility to participate in the AGC Biologics 401(k) plan (including a generous matching contribution from the company and immediate vesting), vacation, sick time, and parental leave. Team Members are also eligible to receive a discretionary annual bonus commensurate to the level of the role. The payout is based on both the company’s performance and the Team Member’s performance. 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. About the company
AGC Biologics is a leading global Contract Development and Manufacturing Organization (CDMO), with a commitment to completing projects right, and on time. Notice
Talentify is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status. Talentify provides reasonable accommodations to qualified applicants with disabilities, including disabled veterans. Request assistance at accessibility@talentify.io or 407-000-0000. Federal law requires every new hire to complete Form I-9 and present proof of identity and U.S. work eligibility. An Automated Employment Decision Tool (AEDT) will score your job-related skills and responses. Bias-audit & data-use details: www.talentify.io/bias-audit-report . NYC applicants may request an alternative process or accommodation at aedt@talentify.io or 407-000-0000.
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