Seagen

Senior Manager, Quality Compliance Programs

Technical Operations & Process Sciences - Zug, Switzerland

Description

Seagen is a global multi-product biotechnology company that develops and commercializes innovative therapies for the treatment of cancer. The company’s industry-leading antibody-drug conjugate (ADC) technology harnesses the targeting ability of antibodies to deliver cell-killing agents directly to cancer cells. In addition to four marketed products, we are advancing a strong product pipeline of novel therapies for solid tumors and blood related cancers designed to address significant unmet medical needs and improve treatment outcomes for patients. More information about Seagen can be found at www.Seagen.com

Position Summary

The Senior Manager, Quality Compliance Program position implements and maintains the Global Inspection Management Process and Readiness in Country Affiliate sites and Global Recall 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 and execute Corporate GMP and GDP Inspection Management Program and Readiness for Country Affiliate Sites in Europe and Great Britain.
• Oversee and manage inspection CAPAs, response generation, issue mitigation, risk identification and process improvements to maintain regulatory compliance for inspection readiness program in support of the Country Affiliates with the Qualified Responsible Persons as a member of Global Quality Compliance.
• Functional responsibilities include execution of the backroom lead inspection role.
• Leads Recall Program implementation and execution of global recall program and acts as global recall coordinator for Global Quality Compliance.
• Supports Corporate GMP/GDP Regulatory Intelligence team -evaluating applicable regulations and guidance documents to support country affiliates and distribution partners.
• Supports complaints program with triage and management of product and vendor complaints.
• Develop and revise Standard Operating Procedures, Work Instructions and training materials as needed.
• 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.
• 12+ 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.
• Recall experience preferred.
• Fluent in multiple languages.

Seagen

Seagen is an Equal Opportunity Employer

Submitted: 06/24/2022