Associate Director Quality Compliance
The Associate Director, Quality Compliance is responsible and accountable for managing the development and implementation of global regulatory compliance programs for Seattle Genetics, suitable to support clinical and commercial products with manufacturing, testing, and distribution in regions around the world. The role leads a team of Global Quality Compliance personnel responsible for internal/external audit programs, auditor development and training, vendor qualification, vendor change notification, and Quality Agreements.
- Provide strategic direction and oversight of the Vendor Qualification Program, including Direct Materials, Contract Manufacturers, Contract Laboratories, Software and support functions: responsible for monitoring vendor compliance with the requirements of cGMPs and applicable regulations, perform audits of external suppliers and/or interface with internal manufacturing site Quality team as applicable
- Ensure vendor risks are systematically assessed, controlled, reviewed, and communicated, and that risk management activities are documented appropriately
- Partner with External Supply Operations to identify and qualify suppliers for Seattle Genetics
- Establish and oversee administration of the routine assessment of suppliers and communicate risk level and qualification status to the organization
- Establish questionnaires for on-boarding suppliers, supplier risk assessment program, and administer the Quality Agreement content and format for both suppliers and CMOs
- Oversee process for the establishment, negotiation, and maintenance of Quality Agreements in close collaboration with SMEs, contract management group and business partners
- Provide strategic direction and oversight for the establishment and execution of the Audit program, including both internal and external audits. Ensure the program drives continuous improvement of the Corporate, site, and country affiliate systems, processes, and operational performance
- Responsible for ensuring a robust auditor training and qualification process is in place
- Provide site-wide leadership regarding establishment of corrective actions in response to audit and inspection findings
- Develop and analyze metrics for areas of responsibility - Ensure metric output is used to further develop/strengthen compliance programs
- May conduct audits and support inspection management activities
- Hire, develop, and champion Quality Compliance staff – as well as provide leadership and coaching
- Identify process improvements in the Quality Compliance department to ensure programs remain compliant with internal procedures and federal and local requirements for Seattle Genetics markets
- Lead and participate in risk assessment, investigation activities, and decision-making for compliance programs
- Review and approve relevant Compliance documentation and ensure documentation supports a compliant state
- 16+ years’ experience in GMP Quality Assurance including responsibilities for Quality Compliance
- 5 years supervisory experience.
- Uses risk-based concepts in developing compliance programs.
- Demonstrated ability to lead, develop and build program infrastructure to support compliance activities and obligations to Health Authorities.
- Demonstrated leadership in Quality & Compliance discipline and in-depth knowledge of global health authority regulations and requirements, with the ability to effectively translate and communicate these requirements into effective global procedures/policies.
- Must possess strong leadership skills to work cross functionally and build strong business relationships with cross-functional teams and leadership.
- Thorough knowledge of FDA/EMA regulations and an ability to quickly understand and interpret new market requirements.
- Must be capable of assessing compliance requirements using sound judgement and decision-making skills.
- Must possess strong communication skills verbally and written.
- In depth knowledge and experience with quality systems, corrective action and preventative action system, and other key tools for managing quality compliance assessments.
- Bachelor’s degree in a scientific discipline or equivalent education and experience.
- Prior experience managing audit programs, vendor management, corrective action plans and Quality Agreements.
- Effective at conducting compliance reviews of guidance for implementation and training for multiple regulatory markets
- Prior auditing experience as a lead auditor for GMP audits
- Experience in Regulatory inspection roles such as host, subject matter expert, or back room lead
As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com.
Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.