Seagen

Associate Director, Vendor and Internal Audit Management

Development - Bothell, Washington

Description

Summary

We are seeking a highly motivated team leader to join us as an Associate Director of Vendor and Internal Audit Management to foster and grow our audit and oversight programs in these areas. This position will be in Bothell, WA, South San Francisco, CA, or potentially remote, and will report to the GCP Director. Your advanced industry expertise and management experience will be employed to define risk management and audit management approaches for both Vendors and Internal Audits. Your demonstrated leadership and analytical thinking will provide thought leadership (influence without authority) on abstract ideas and situations across multiple functional areas of the business and external CRO stakeholders to resolve challenging vendor and internal issues. The position will direct the refinement of the existing Vendor Oversight and Internal Audit infrastructure. This role will provide key leadership at the associate director level and will elevate the internal audit program and vendor oversight function within the R&D Quality organization to the next level. You will manage QA staff and/or contractors.

Responsibilities:

• Partner with leaders in Vendor Strategy Management and other R&D departments to ensure an effective vendor selection and ongoing oversight process is in place and maintained.
• Define a periodic risk-based, re-auditing program that assesses current vendor performance and reports out current qualification status.
• Strategically utilize quality and compliance data (e.g., KPIs, QTLs, milestones) to monitor vendors and internal Seagen activities.
• Exercise processional judgement for conducting Risk Assessments, Risk mitigation planning, and monitoring to define the vendor and internal audit schedules.
• Supervise the global GCP/GLP/GVP vendor and internal auditing program/calendar, balance workload, and arrange contract audit support when needed
• Maintain the vendor and internal audit management tools and repository.
• Ensure responses to audit reports are satisfactory and the commitments are tracked to closure.
• Define criteria that will guide which audit responses will need effectiveness checks to verify the audit CAPA outcome. Ensure effectiveness checks occur.
• Supervise audit staff and contractors’ performance versus assigned goals.
• Participate in select audits of partners, vendors, internal processes and/or clinical sites where needed.
• Implementing departmental goals, infrastructure, and procedures.
• Fostering collaboration across RDQ functional teams.
• Independently identify and raise major risks/areas of exposure to senior management.

Required Qualifications:

• Minimum 10 years in GCP, GLP, GVP, and/or IT compliance
• Minimum 3 years of supervisory/management experience
• Well versed in 21CFR11 and Annex 11 requirements and practical application to vendor and internal auditing
• Project management experience
• Leading process improvement initiatives
• BS/BA degree or equivalent.

Preferred Qualifications:

• Oncology Therapeutic area expertise.
• International auditing experience.
• Regulatory Affairs Certification (RAC).
• Have had Certified Quality Auditor (CQA) training.

As the leading employer in our industry in the Pacific Northwest, Seagen is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seagen, please visit www.seagen.com.

Seagen is an equal opportunity employer. All qualified applications will receive consideration for employment.

To prevent the spread of COVID-19, and as an integral part of its public health and safety measures, Seagen requires that all newly-hired employees be fully vaccinated against COVID-19 before commencing employment, subject to reasonable accommodation and other requirements of applicable federal, state, and local law.

Apply:

Seagen

Seagen is an Equal Opportunity Employer

Submitted: 11/12/2021