Senior Manager Inspection and Internal Audit Management

Summary:We are seeking a highly motivated team leader to join us as a Senior Manager of Inspection and Internal Audit Management to support our drug development programs.

This position will be in Bothell, WA, South San Francisco, CA and will report to the GCP Director.

The successful candidate will be responsible for preparing for and facilitating the management of internal process audits, partner company audits and a wide variety of regulatory agency inspections (e.g., FDA, EMA, MHRA).

The position will also include refining the existing inspection management infrastructure; utilizing QMS data to inform the internal audit program; anticipating and tracking inspections and partner audits; and conducting inspection readiness and preparation activities ensuring early identification of risk and continuous improvement.

You may manage QA staff and/or contractors.Principal Responsibilities:* Independently manage pre-inspection activities for GCP, GLP, and GVP inspections* Facilitate onsite/virtual inspections and partner audits* Provide guidance and strategic planning to Seagen functional teams during inspections and partner audits* Coordinate responses to partner audit reports and regulatory agency inspection findings (if any).

Ensure all commitments are reviewed and endorsed by senior management.* Holistically assess inspection risks for GCP, GLP, and GVP at regular intervals and ensuring risk assessment and mitigation are conducted as early as possible in the drug development lifecycle* Review and analyze regulatory inspection data issued by regulatory authorities (e.g.

MHRA, EMA, FDA)* Review relevant regulatory and competitive intelligence data to inform readiness and preparation activities.

Develop novel QA solutions based on insights gained from the analysis* Lead inspection readiness teams to ensure training for Seagen Development stakeholders with respect to inspection readiness is prepared and delivered* Help conduct mock interviews for subject matter experts (SMEs) during inspection preparation* Lead and/or coordinate inspection readiness visits at select partners, CROs, and/or clinical sites where needed* Provide support for inspections at Seagen’s clinical sites, CROs, and business partners* Maintain the inspection management tools and repository* Assist RDQ management in the development and implementation of strategic procedures and work practices to ensure continuous quality improvement* Ensure the Quality Management System (QMS) records are monitored and kept current* Provide QMS, inspection data trends and inspection readiness updates for executive management review* Exercise processional judgement for conducting Risk Assessments, Risk mitigation planning, and monitoring to define the internal audit program.* Strategically utilize quality and compliance data (e.g., KPIs, QTLs, milestones) to monitor the internal Development activities and recognize potential risks and issues.* Work closely with the R&D Quality Director of Continuous Improvement to process map clinical trial processes and procedures to identify gaps and develop inspection readiness and internal process audit plans* Conduct effectiveness checks to verify the CAPA outcome* Participate in select audits of partners, CROs, 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 managementRequired Qualifications:* Minimum 8 years in GCP, GLP, and/or GVP quality assurance* Supervisory/management experience (1-2 years)* Experience managing regulatory authority inspections of GCP, GLP, and/or GVP* Project or team management experience* Leading process improvement initiatives* BS/BA degree or equivalentPreferred Qualifications:* Oncology Therapeutic area expertise* International inspection support experience* Clinical or Laboratory Quality Assurance Qualification/CertificationAs 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 without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.#LI-TC2