Senior Director of Quality

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.

Job Summary:

The Senior Director of Quality is responsible for oversight of the Quality Assurance (QA), Quality Control (QC), Quality Systems (QS), Validation, and Regulatory Compliance groups in support of the Colorado sites (Boulder and Longmont) at AGC Biologics. The Senior Director 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 operationalize the facility and integrate it into the AGC Biologics QMS. The Senior Director will lead Colorado's development and commercial manufacturing operations for recombinant proteins and cell & gene therapies.
This role will be accountable for the site quality systems and ensuring overall GMP compliance with current regulatory requirements and guidelines.

Essential Job Duties:

• 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 setting strategy and goals for Boulder and Longmont.
• Mentor and develop staff members.
• Hold final accountability for GMP compliance at the Boulder and Longmont facilities.
• Set the overall strategies, tactics, and directions for the site QA, QC, Quality Systems, Validation, and Regulatory Compliance departments in alignment with AGC Biologics QMS.
• Align departmental goals and objectives with corporate goals to ensure site success.
• Develop departmental budgets that support corporate and departmental goals and manage them throughout the fiscal year.
• Develop and drive Global Quality cross-site initiatives.
• Provide advice and counsel to the site Leadership Team on regulatory GMP compliance issues.
• Serve as the principal spokesperson with customers and regulatory agencies on GMP compliance matters.
• Negotiate and align with executive management and regulatory agencies at the highest levels.
• Work with other AGC Biologics sites to integrate quality systems.
• Other duties as assigned.
   

Education:

• Requires a 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 the biopharmaceutical or pharmaceutical industry, with significant leadership experience.
• Strong working knowledge of Quality Systems (FDA QSIT and ICH Q10) and implementation to meet FDA and EMA requirements.
• Experience supporting regulatory filings (e.g., INDs, BLAs) and leading inspections for US and foreign regulatory agencies.
• Experience developing, implementing, and executing strategic plans.
• Exceptional customer interface skills.
• Ability to work the hours necessary to support operations activities.
• Technical background in protein development is preferred.
• Mentorship responsibility for Quality staff and peers.
• Responsible for oversight of Quality staff.
• Independently directs and controls activities and outcomes in major functional areas.
• Typically manages a sizeable, highly discretionary budget.
• Accountability for site adherence to quality regulations.
   

Compensation Range:

$194,000 - $266,750
 

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.