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.

The Senior Manager, Corporate Quality Assurance, is responsible for managing the development and implementation of global quality systems across all AGC Biologics sites. This includes the establishment of global policies, procedures, guidance, training, and other tools required for its global deployment. This position will support the harmonization or improvement of our Quality Management System, which includes Deviation, Corrective and Preventative Action (CAPA), and Change Management. Provide quality oversight of the QMS system and periodically perform Audits.
 

PRINCIPAL RESPONSIBILITIES:

• Establish controls, global policies, procedures, or guidance documents to define and align the operations of the Quality Management Processes associated to Deviation, CAPA, and Change Management (i.e., change control) for internal and external activities.

• Drive the implementation of the Quality Management System through requirements building, cross-site harmonization, and engagement with IT for build and deployment.

• Support sites with the implementation of technology solutions for processes used across the Quality Control and Facility operations, including TrackWise Digital (including next generation or future state systems), data acquisition systems, and others.

• Support the automation of data gathering, processing, and information management in support of Quality compliance, operational KPIs trending, and issuance of periodic trending reports.

• Drive quality continuous improvement initiatives to enhance the productivity and efficiency of our operations globally.

• Support sites as needed in interactions with other key functional units as well as with external clients.

• Provide guidance on the management of deviations, CAPAs, OOS/OOT investigations, and change controls initiated in the laboratory. Review deviation evaluation and resolution activities as required.

• Develop and manage cross site communities and serve as Global SME for this system. Lead and/or provide mentorship to site representatives.

• Conduct GMP Corporate Audits at sites as needed.

• Serve as an SME during regulatory inspections.

• Serves as Business Owner of IT Systems pertaining to Deviation, CAPA, and Change records.

• Travel as required, both domestically and internationally, to ensure compliance with the Company’s Quality Management Systems and execute audits of processes as required.

• Ensure GMP compliance issues are addressed proactively, and support the quality of new processes and products.

• Oversee complex problems across the company.

• Ensure continuous improvements for processes, programs, and procedures.

KNOWLEDGE, SKILLS & ABILITIES:

• Demonstrated leadership in Quality & Compliance discipline

• In-depth experience with Quality Management System, specific to Deviation, Corrective and Preventative Action, and Change Control

• Subject matter expertise in global regulatory requirements and expectations as defined by pharmaceutical regulatory authorities, as it relates to Deviation, Corrective and Preventative Action, and Change Control

• Experience performing audits.

• Excellent facilitation and project management skills, with strong verbal and written communication skills.

• Proven ability to lead and implement multiple projects/tasks simultaneously with competing and/or changing priorities; effective time management.

• Must be capable of effectively presenting information to management, peers, clients, and regulatory authorities.

EDUCATION/EXPERIENCE:

• 7+ years of experience in deployment and/or maintenance of quality system programs.

• 5+ years of practical experience in a pharmaceutical manufacturing environment.

• 3+ years of experience in a global or corporate function.

• Exceptional customer interface skills.

• Ability to work hours necessary to support global network needs.

• Requires a bachelor's or advanced degree or equivalent combination of education and experience.

COMPENSATION RANGE:

$124,230 - $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.