Quality Regulatory Compliance Sr. Manager
AGC Biologics is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. Because of our dedication to building and empowering our internal teams, AGC Biologics is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics and cell and gene therapies. We forge exceptionally strong partnerships with our clients, and we never lose sight of our pledge to deliver a reliable and compliant drug substance supply, Right, On time. For more information, visit www.agcbio.com.
Summary:
The Quality Regulatory Compliance Sr. Manager is responsible for execution of site infrastructure for inspection management consistent with Global Policies and Guidelines. They will lead activities supporting operational alignment for remediation of the areas of highest compliance risk, communicate across site functions and is a key contributor to the development of behaviors and practices that foster a culture of constant inspection readiness.
Principle Responsibilities:
- Provide leadership and vision to drive a quality culture by executing an inspectional preparation strategy aligned to business goals to achieve positive results for the organization
- Implement key inspectional processes such as compliance risk assessment, presenter preparation, logistical infrastructure and inspection staff training program
- Facilitate alignment of local program with global Policy requirements
- Drive collaboration across Seattle AGC Biologics site functions to remediate top compliance risks and engage in cross-functional planning to leverage resources to improve speed of resolution
- Partner with site and global peers to execute preparation activities for Client and Regulatory Audits/Inspections
- Routinely interface with internal and external auditors to coordinate site inspections
- Lead interactions with Clients to remediate regulatory filing content, discuss compliance gaps and put effective Quality Agreements in place
Knowledge, Skills & Abilities:
- Technical expertise in regulatory requirements across multiple jurisdictions which enables of assessment of compliance risk
- Deep knowledge in the techniques used by auditors/inspectors to judge compliance level of the site
- Skilled in strategic thinking, managing through systems, communication and negotiation
- Actively develops and maintains strong professional relationships building trust and respect across the organization
- Lead through influence, effectively build alignment and collaborate with multiple stakeholders
- Assess performance roadblocks and develop appropriate solutions
- Willing to have difficult conversations, meetings, and make decisions related to readiness of areas for inspection
Education/Experience:
- Bachelor's degree in scientific or regulatory area
- A minimum of 8 plus years' experience required
- Direct experience leading or supporting multiple functions in a pharmaceutical or a regulatory industry is required
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.