GMP Auditor
Zug, Switzerland
vor 4 Tg.

GMP Auditor

Technical Operations & Process Sciences Zug, Switzerland

Position at Seagen

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
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