Director, Quality Assurance Operations

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:

We are seeking an experienced and strategic Director of Quality Assurance to lead our QA Operations team and play a key role in shaping the future of our manufacturing site. This position is critical to ensuring compliance with cGMP standards and regulatory requirements, while also supporting our development into commercial manufacturing and the advancement of development-stage products.
 

In this role, you will oversee daily QA operations, including lot disposition, and serve as a trusted partner to cross-functional teams in Manufacturing, Facilities, and Quality Control. You will also champion continuous improvement initiatives aimed at increasing operational efficiency and maintaining the highest standards of product quality.

PRINCIPAL RESPONSIBILITIES:

• Develops, establishes, and maintains quality assurance programs and systems, processes, procedures, and controls, ensuring that performance and quality of products conform to established phase-appropriate cGMP standards and regulatory requirements.
• Develops, implements, and maintains quality systems (e.g., disposition) required for commercial and clinical operations from cGMP and operational efficiency perspectives.
• Manages QA support for the review and approval of documentation such as batch records, process and equipment validation protocols and reports, product specifications, and change controls.
• Evaluates proposed process changes and improvements. Ensures proposed process changes are consistent with applicable regulatory guidelines and assures changes that affect a regulatory submission or require communication to regulatory authorities are appropriately conveyed.
• Provides expertise and guidance in interpreting existing and emerging governmental regulations, agency guidelines, and internal policies to assure compliance.
• Leads and supports investigations associated with major deviations in operations.
• Represents the company in dealing with clients and leads the negotiation of quality agreements.
• Partners with Manufacturing, Engineering, and QC to enhance the GMP compliance profile of the site by ensuring the timely closure of investigations and implementation of appropriate corrective actions.
• Ensures that all trends are evaluated, that root causes are identified, and that corrective actions are implemented.
• Authors, reviews, and/or approves internal quality documents (SOPs, deviations, CAPAs, change controls, etc.) and external regulatory agency documents.

KNOWLEDGE, SKILLS, AND ABILITIES:

• Ability to understand and apply GMP regulations as they relate to manufacturing, raw materials, testing, and facility operations.
• Demonstrated ability to effectively manage multiple tasks utilizing organization and prioritization skills, self-motivated.
• Strong interpersonal, written, and oral communication skills.
• Strong problem-solving skills.
• Strong management, staff development, and mentoring skills.

EDUCATION AND EXPERIENCE:

• Bachelor's degree in Physical Sciences, Life Sciences, or Engineering; an advanced degree is preferred.
• 12 years of relevant experience in a biotechnology and GMP environment.
• Experience with QA and GMP compliance in clinical and commercial drug substance manufacturing.

COMPENSATION RANGE:
$164,400 - $226,050

 

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.

Salary : $164,400 - $226,050