Senior Manager, Corporate Quality Assurance

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 a Senior Manager, Corporate Quality Assurance to lead the global development and deployment of our Quality Management System across AGC Biologics’ sites — all from a fully remote role. You will play a key role in shaping and harmonizing quality policies, procedures, and tools that support deviation management, corrective actions, and change control worldwide. This position offers the opportunity to influence quality processes on a global scale, drive continuous improvement initiatives, and work closely with cross-functional teams and IT partners.

This role requires flexibility to support our global network and occasional travel for audits or compliance activities.

Schedule: Monday through Friday, 40 hours per week

Compensation: $124,230 to $170,940.

Principal Responsibilities

• Develop and implement global controls, policies, procedures, and guidance documents to align quality management activities related to Deviation, CAPA, and Change Management for both internal teams and external partners.

• Lead the rollout and continuous improvement of the Quality Management System by collaborating across sites and working closely with IT to design and deploy solutions.

• Support the adoption of technology tools such as TrackWise Digital and data acquisition systems to improve quality compliance and reporting.

• Help automate data collection and processing to enhance quality monitoring and deliver insightful trending reports.

• Drive initiatives focused on quality improvement and operational efficiency throughout the company’s global operations.

• Provide expert guidance and support to sites on deviation handling, CAPA, OOS/OOT investigations, and laboratory change control activities.

• Build and lead global quality communities by mentoring site representatives and serving as a subject matter expert.

• Conduct GMP corporate audits and participate as a quality expert during regulatory inspections.

• Own and manage IT systems related to Deviation, CAPA, and Change records to ensure they meet business requirements.

• Travel domestically and internationally as needed to support audits, compliance verification, and quality initiatives.

• Address GMP compliance proactively and support the quality of new processes and products.

• Oversee resolution of complex quality issues and ensure continuous improvement of quality processes and programs.

Knowledge, Skills & Abilities

• Demonstrated leadership in quality and compliance within pharmaceutical manufacturing environments.

• Deep expertise in Quality Management Systems, especially relating to Deviation, CAPA, and Change Control processes.

• Strong knowledge of global regulatory requirements and expectations in pharmaceutical quality systems.

• Experience conducting audits with professionalism and thoroughness.

• Excellent communication skills, both verbal and written, with the ability to clearly present information to a variety of audiences including management, peers, clients, and regulatory bodies.

• Strong facilitation and project management abilities, with the skill to manage multiple priorities and shifting deadlines.

• Ability to mentor and lead cross-functional teams effectively.

Education / Experience

• Minimum 7 years experience deploying or maintaining quality system programs.

• At least 5 years of practical experience in pharmaceutical manufacturing environments.

• 3 or more years in global or corporate quality functions.

• Proven ability to work flexibly to support global operations.

• Bachelor’s degree or higher, or equivalent combination of education and experience.

• Exceptional customer engagement and collaboration skills.

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.