Seagen

Inspection Readiness Lead

Corporate Functions - Zug, Switzerland

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 Manager, Quality Compliance Programs position, implements, and maintains the Ex-US Inspection Management Process and Regulatory Intelligence programs in alignment with corporate directives by collaborating cross-functionally and geographically to ensure consistency with established standards and compliance with regional regulatory and industry expectations.

Principal Responsibilities:

• Implement Ex-US Inspection Management and Readiness programs.
• Oversee and manage the regulatory inspection process, inspection readiness training, and provide inspection support to country affiliates, distribution partners and corporate teams.
• Functional responsibilities include execution of the backroom lead inspection role.
• Provide support to Qualified and Responsible person inspection readiness activities including the response process and follow up of mitigation activities, including coordination and interface with Corporate Compliance.
• Supports Regulatory Intelligence team -evaluating applicable regulations and guidance documents to support country affiliates and distribution partners.
• Perform GMP/GDP audits to support the corporate audit schedule.
• Develop and revise Standard Operating Procedures, Work Instructions and training materials as needed.
• Assist in administration of CAPAs as appropriate.
• Participate as SME, or other required support in regulatory inspections and audits.
• Assist in special projects, process improvements and global initiatives as required.

Required Qualifications:

• BA/BS degree preferred and/or equivalent experience.
• 5+ years’ experience in GMP Quality Assurance.
• Demonstrated knowledge and experience in the interpretation and application of FDA/EMA regulations and ICH requirements for both domestic and international territories.
• Deep expertise in leading and participating in audits.
• Proven track record of applying risk management principles.
• Ability to work well in both internal and external teams, including experience of virtual teams.
• 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.
• Excellent communicator both verbally and in writing with all levels of staff, both inside and outside of the organization.
• 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:

• Good Distribution Practice experience preferred.
• Inspection and/or Audit management experience.
• Fluent in multiple languages.

Education:

• BA/BS degree preferred and/or equivalent experience.

Seagen

Seagen is an Equal Opportunity Employer

Submitted: 05/27/2022