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Manager, Quality Compliance
vor 1 Monat
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:
- 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#LI-LO1
