Seagen

Director Quality Compliance Issue Management & Inspection

Technical Operations & Process Sciences - Bothell, United States

Description

Seagen is a global, multi-product biotechnology company dedicated to developing and commercializing transformative cancer medicines. As the industry leader in antibody-drug conjugate (ADC) technology, we pioneered a new generation in the science of harnessing antibodies to deliver cell-killing agents directly to cancer cells. Seagen’s dedication to improving the lives of cancer patients goes beyond science, and we believe that every employee has a role in contributing to this mission. By working together with a shared dedication and diverse perspectives, we are able to reach our full potential and make a real difference in the world. Seagen is a fast-growing company and has an abundance of opportunities available for you to grow your career. Put your passion to work at Seagen and join us!

Summary:

The Director, Quality Compliance establishes and oversees Issue Management and Inspection Programs supporting global manufacturing, testing, and distribution of clinical and commercial products. The role leads a team of Quality Compliance personnel responsible for Inspection Readiness and Management, Product Complaint handling, Product Recalls, Regulatory Intelligence and Health Authority product reporting. This position is responsible for providing strategic leadership and collaboration within the organization, and with strategic partners, to ensure products and processes comply with applicable global standards, regulations and guidelines.

Principal Responsibilities:

• Establish and oversee Issue Management including Product Complaints, Product Recalls, Incident Escalation, Site Master File requirements, and Health Authority Reporting process
• Provide strategic direction and oversight of Inspection Readiness and Management business process supporting Seagen Corporate, Internal Manufacturing Sites and Country Affiliates
• Provide strategic direction and oversight of Regulatory Intelligence business process supporting Seagen Corporate, Internal Manufacturing Sites and Country Affiliates
• Ensure high level of inspection readiness at all sites (internal and external). In close collaboration with areas subject matter experts, plan and administer the program Inspection readiness (including Pre Approval Inspections) across the supply chain
• Lead and train teams that support inspection management activities
• Participate in the development, implementation and maintenance of inspection process procedures and templates
• Provide site-wide leadership regarding establishment of corrective actions in response to inspection findings
• Quality point of contact for management of product defects, complaints, recalls, Biological Product Deviation Reports, Field Alerts and other applicable Health Authority notifications related to product defects
• Create, publish, and maintain metrics that measure the health and effectiveness of Compliance programs
• Hire, develop, and champion Quality Compliance team – 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 Seagen markets
• Review and approve relevant Compliance documentation and ensure documentation supports a compliant state

Required Qualifications:

• 18+ years’ experience in GMP Quality Assurance including responsibilities for Quality Compliance
• 10 years supervisory experience
• Provides strong leadership. Is able to recruit, develop and retain first class self-driven talent into the Quality Compliance function. Is a collaborative partner with Global Quality and Technical Operations leaders. Fosters cooperation across multiple organizational functions and levels
• Extensive inspection experience in a biotech or pharmaceutical development environment and knowledge of cGMP and Good Distribution Practices (GDP)
• 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, requirements, and notification responsibilities 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
• Exceptional knowledge in product regulatory requirements and an ability to quickly understand and interpret new market requirements
• In-depth working knowledge of US and worldwide GxP regulations
• Ability to negotiate a strategic position after taking feedback from multiple sources
• Experience driving decision making Ability to succinctly communicate level of risk, priority, or impact to the business
• Travel (US domestic and overseas) up to 10%, or as needed

Preferred Qualifications:

• BA/BS Degree.
• Experience leading and implementing Corporate Compliance programs at sites and affiliates.

As the leading employer in our industry in the Pacific Northwest, Seagen 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 Seagen, please visit www.seagen.com.

The hiring pay range for this position is $184,000 to $237,600 per year based on skills, education and experience relevant to the role. Other components of total compensation include a competitive equity grant at the time of hire (with additional annual grants, and grants upon promotion when applicable), and an annual bonus.

Seagen 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.

To prevent the spread of COVID-19, and as an integral part of its public health and safety measures, Seagen requires that all newly-hired employees be fully vaccinated against COVID-19 before commencing employment, subject to reasonable accommodation and other requirements of applicable federal, state, and local law.

Apply:

Seagen

Seagen is an Equal Opportunity Employer

Submitted: 02/03/2023