Seagen

Manager, Quality Compliance - Auditor

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.

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:

• BA or AA and 2+ of related
• 12+ 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
• 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: 09/29/2023