Seagen

Manager Quality Compliance Audits

Technical Operations & Process Sciences - 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 - Audits is responsible for planning and conducting GMP quality audits supporting both clinical and commercial programs.

Principal Responsibilities:

• Represent Seagen in external and internal audits, and on cross-functional teams and initiatives.
• Perform audits in accordance with Seagen standard operating procedures and quality policies.
• Schedule, prepare, and conduct audits in support of GMP activities including agendas, responses, reports, statuses, and audit closure.
• Assemble and coordinate activities of the audit team.
• Communicate audit results to management and auditees through written audit reports.
• Communicate to stakeholders on potential risk and product impact from observations and GMP deficiencies found during audits.
• Lead post-audit activities, and follow up on any vital corrective and preventive actions.
• Assist with training/orientation for new Quality Auditing staff.
• Organize, archive, and maintain GMP Supplier Audit documentation.
• May coordinate auditor assignments.
• Gather KPI and metric data.
• Proactively evaluate systems and processes to identify improvements with a focus to simplify and standardize. Lead and drive improvements as required.
• Provide support to Seagen sites and affiliates with supplier qualification issues and supplier risk assessment based on audit result when required/requested.
• Review completed audit documentation and verify database entries for completeness and accuracy.
• Revise and approve standard operating procedures and other controlled documents as necessary.
• May assist with regulatory inspections or other duties as assigned.

Required Qualifications:

• Bachelor’s degree in a scientific discipline.
• 5+ years’ experience in GMP Quality Assurance including responsibilities for Quality Compliance and auditing.
• Ability to interpret policies, standards, and regulations, and then evaluate potentially critical problems.
• Ensure compliance to written procedures, and exercise judgment in evaluating quality systems, processes, procedures, and protocols for compliance.
• 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.
• In depth knowledge and experience with quality systems, corrective action and preventative action system, and other key tools for managing quality compliance assessments.
• Independent decision making with a high degree of initiative.
• Strong oral and written communication, collaboration, and interpersonal skills with the ability to influence others, facilitate team interactions, and partner with key stakeholders.
• Motivated self-starter; detail and results oriented.
• Well organized and efficient with ability to manage multiple priorities.
• Fluent in spoken/written English language.
• 25% - 40% domestic and international travel required.
• Thorough understanding of local compliance, as well as a sound ethical approach to business.

Preferred Qualifications:

• 5+ years prior auditing experience as a lead GMP auditor in pharmaceutical, biologics or medical device industry.
• Expert knowledge of EMA/EU regulatory guidance.
• Experience with commercial drug product operations including injectable parenterals, finished goods production, API and excipient manufacturing, and analytical testing.
• Acts as a specialist in complex technologies (e.g., sterile injectables, low bioburden, biotech); can perform special assessments and participate on process audit teams.

Seagen

Seagen is an Equal Opportunity Employer

Submitted: 05/13/2022