Director, Regulatory Compliance
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 Seattle Director Regulatory Compliance is responsible for the development of a site infrastructure for management of inspections, internal and external audits consistent with Global Policies, SOPs 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.
PRINCIPAL RESPONSIBILITIES:
- Provide leadership and vision to drive a quality culture by developing and implementing an inspectional preparation strategy aligned to business goals to achieve positive results for the organization
- Implement key inspectional/audit processes such as compliance risk assessment, presenter preparation, logistical infrastructure, inspection staff training program and a talent management program for inspection/audit speakers & logistical support staff
- Facilitate alignment of local program with global requirements
- Implement and lead internal and client audits
- Drive collaboration across site functions to remediate top compliance risks and engage in cross-functional planning to leverage resources to improve speed of resolution
- Partner with peers at the operational sites to share and adopt best practices across the network to drive continuous improvement
- Routinely interface with internal and external auditors to coordinate site inspections/audits
- Routinely present information to senior management related to site preparation status, needed resources and/or roadblocks
- Responsible for obtaining and renewing required regulatory/compliance site licenses
- Own site self-inspection program
- Responsible for completion of Quality Agreements with external clients
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
- Facilitate organizational change related to quality systems across multiple functions
EDUCATION/EXPERIENCE:
- Facilitate organizational change related to quality systems across multiple functions
- A minimum of 10+ years' experience required
- Direct experience leading or supporting multiple functions in a pharmaceutical, biotech or a regulatory industry is requires
- Direct Experience hosting and/or leading Regulatory Inspections, Audits and continuous improvement projects
- Management experience, including a demonstrated ability to effectively manage staff and multiple tasks utilizing organization and prioritization skills, driven to meet timelines, and results-orientated
- Experience in protein therapeutics, cell gene therapy and/or viral vector manufacturing preferred
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.