Manager, Quality Control, Compliance

About AGC Biologics
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.  

SUMMARY:

The Quality Control Manager will provide leadership for GMP compliance and quality systems management within Quality Control. This position will provide direction for execution of deviations, CAPAs, and change controls within the Quality Control department. Additionally, the position will oversee QMR and APR deliverables.  The ideal candidate will be an expert in laboratory compliance and developing interdepartmental relationships.

PRINCIPAL RESPONSIBILITIES:

• Oversee QC compliance team and provide training to staff
• Provide subject matter expertise to prepare for internal audits and regulatory agency inspections
• Provide oversite of QC responses to audits and inspections and coordinate resulting CAPAs as necessary
• Provide oversite of QC contribution to APR and QMR including metric development
• Oversee and mature laboratory investigations, deviations, and CAPAs
• Oversee and mature departmental training program
• Oversee and mature departmental data integrity program
• Drive continuous improvement to related processes
• Develop and coach staff in alignment with company goals and individual career aspirations

KNOWLEDGE, SKILLS & ABILITIES:

• Extensive experience with Quality Systems and Regulatory Inspections
• Extensive experience with metric development, monitoring and improvement
• Detailed understanding of data integrity requirements for GMP operations, including 21CFR Part 11
• Demonstrated ability to work effectively on cross-functional teams and engage with external clients
• Strong organizational and project management skills, including technical writing and presentation of technical data.

EDUCATION/EXPERIENCE:

• BS/BA degree with 5+ years of industry experience, or
• Master’s degree with 3+ years of industry experience. Equivalent education and experience may substitute for stated requirements.

COMPENSATION RANGE:

$94,000 - $129,250

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.