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 Manager / Sr. Manager, Quality Assurance for QC position is responsible for managing a team of Quality Assurance Scientists responsible for quality oversight of the Quality Control (QC) department to ensure compliance with all standards, procedures, and regulations. The QA for QC team is responsible for the QA review and approval of SOPs, Methods, Deviations, Laboratory Investigations, Change Controls, Method Validation and Equipment Qualification activities related to the QC department. Lead projects or represent QA interests in multidisciplinary project teams.

KEY RESPONSIBILIES:

• Manage and lead team of Quality Scientists responsible for quality oversight of Quality Control operations
• Provide QA oversight for quality control activities, including review/approval of methods, stability protocols/reports, and certificate of analyses.
• Supports the QA review and approval of method validation, method transfer, and equipment qualification activities related to the quality control laboratories.
• Acts as QA approver for quality system records, such as Change Controls, Deviations, CAPA and Laboratory Investigations.
• Partners with QC and other departments for root cause analysis, problem solving and implementing corrective and preventive actions.
• Demonstrates success using compliance knowledge, creativity and regulatory perspectives to solve problems.
• Accountable for decisions and results that ensure timelines are met.
• Responsible for making recommendations in accordance with federal and international regulatory requirements and industry standards.
• Works closely with other team members in a cooperative fashion to ensure project progression.
• May participate in internal/external audits and regulatory inspections.
• Perform or support any other tasks necessary to maintain the product quality and site cGMP compliance.
• Manages team performance, development and strategy to ensure appropriate resource utilization.
• Acts as a mentor to staff members.
• Drive department and site goals, with other Quality Operations leaders, to achieve success.
• May act as a delegate for the Director, Quality Operations.
• Other duties as assigned.

KNOWLEDGE, SKILLS & ABILITIES:

• Strong verbal and written communications skills
• Excellent analytical and problem-solving skills
• Ability to seamlessly manage a variety multiple project simultaneously
• Outstanding customer service skills with the ability to work effectively with diverse groups at various levels within the company
• Deeply well organized, flexible, and responsive
• Good judgement with strong interpersonal relationship, team building, and collaboration skills

EDUCATION/EXPERIENCE:

• Sr. Manager: BS/BA degree in Chemistry, Microbiology or Life Sciences with 8+ years of industry experience, or Master’s degree with 5+ years of industry experience in a GMP/FDA regulated environment. Equivalent education and experience may substitute for stated requirements.
• Manager: BS/BA degree in Chemistry, Microbiology or Life Sciences with 5+ years of industry experience, or Master’s degree with 3+ years of industry experience in a GMP/FDA regulated environment. Equivalent education and experience may substitute for stated requirements
• Previous managerial experience required.
• Experience with vaccine or adjuvant manufacturing preferred or cell-based production and purification technologies.
• Ability to understand and apply GMP regulations as they relate to manufacturing, test laboratory and facility operations.
• Experience with tech transfer, test method validation, equipment qualification and process validation preferred.
• Client and/or Regulatory audits and inspection experience is preferred.
• Demonstrated ability to effectively manage staff and multiple tasks utilizing organization and prioritization skills, driven to meet timelines, results-oriented.

COMPENSATION RANGE:

$108,080 - $170,940

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.