Seagen

Senior Manager Quality Compliance

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 Sr. Manager, Quality Compliance develops and maintains corporate compliance programs in alignment with corporate directives. The position is responsible for Complaint Management Process and Inspection Readiness Program.

Principal Responsibilities:

• Program owner for the Product Complaint Management Process, Inspection Readiness Program, and compliance process improvements
• Oversee and manage inspection CAPAs, response generation, issue mitigation, risk identification and process improvements to maintain regulatory compliance for inspection readiness program
• Will support inspections and partner audits as part of inspection management team and subject matter expert for assigned functional responsibilities
• May support development and management of CAPAs for supporting programs
• Create and maintain quality directives pertaining to owned programs
• Develop and revise Standard Operating Procedures, Work Instructions and training materials as needed
• Provide leadership to cross-functional team members on compliance topics
• Ensure meaningful metrics are established and communicated for area of responsibility
• Identify process improvements in the Quality Compliance department to ensure programs remain compliant with internal procedures and federal and local requirements for Seagen markets
• Lead and participate in risk assessment, investigation activities and decision-making for compliance programs
• Assist in special projects, process improvements and global initiatives as required
• Support other duties as assigned

Required Qualifications:

• 10+ years’ experience in GMP Quality Assurance including responsibilities for Quality Compliance
• 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 and 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 for implementation
• Must be capable of assessing compliance requirements using sound judgement and decision-making skills
• Must possess strong verbal and written communication skills
• In-depth knowledge and experience with quality systems, corrective action and preventative action systems, and other key tools for managing quality compliance assessments
• Strong commitment to the accomplishment of tasks, adherence to procedures, and the initiative to identify opportunities for improvement
• Should possess a flexible risk-based approach to problem solving and be an adept negotiator
• Self-motivated, flexible, adaptable but focused and persistent
• Proven track record of applying risk management principles
• Ability to work in a fast-paced matrix environment
• Ability to prioritize work and handle multiple assignments, while maintaining a high level of quality
• Ability to travel domestically and internationally

Preferred Qualifications:

• Bachelor’s degree in a scientific discipline or equivalent education and experience
• 7+ years prior experience managing Investigations (i.e., deviations, product complaints, recall assessments, and/or supplier complaints), Project Management
• Effective at leading inspections, investigations, performing regulatory surveillance activities and regulatory guidance reviews
• Prior experience in GMP inspection readiness and compliance risk management programs

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 $138,000 to $178,000 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.

Apply:

Seagen

Seagen is an Equal Opportunity Employer

Submitted: 03/03/2023