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 Incident Escalation Management and GMP/GDP Regulatory Intelligence Program.

Principal Responsibilities:

• Program lead for the Incident Escalation and Management Process for identification, management and communication of potential significant events impacting the organization
• Program lead for the GMP/GDP Regulatory Intelligence program supporting surveillance, triage and assessment of regulatory guidelines impacting GMP and GDP (Good Distribution Practices) for Seagen markets
• May 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
• Provide leadership to cross-functional team members
• 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 Seattle Genetics markets
• Lead and participate in risk assessment, investigation activities and decision-making for compliance programs
• Support other duties as assigned

Required Qualifications:

• 14+ 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

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 and Regulatory Intelligence Programs
• Effective at leading investigations, performing regulatory surveillance activities and regulatory guidance reviews
• Previous supervisor experience
• Prior auditing experience auditing or managing GMP inspections

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: 03/10/2023