Seagen

Manager Quality Compliance Programs

Description

Summary:

The Manager, Quality Compliance Programs is responsible for managing multiple Quality programs or processes such as Product Complaints, investigations, corrective actions and compliance metrics. The position is responsible for leading cross-functional teams in timely complaint investigations for multiple products, and is a liaison between Medical Affairs, Drug Safety, and Quality. The position is responsible for communication to key stakeholders including affiliates and partners and must be able to interact with staff at various management levels. Additionally, this position will be designated as the Quality Compliance electronic systems owner and will collaborate with the Compliance team, Quality Systems and IT in identifying and implementing electronic systems to support Quality Compliance programs.

Principal Responsibilities:

• Product Compliant business process owner
• Facilitate and lead Product Complaint investigations with appropriate subject matter experts
• Assign CAPAs related to outcome of product complaint investigations
• Report to Management on product complaint metrics by drafting and issuing periodic reports to site management as requested
• Own and administer the electronic product complaint business process
• Create and Manage Product Complaint Templates
• Primary Compliance representative responsible for evaluating and expanding compliance program electronic processes
• May support system upgrades by writing/revising, executing, and reviewing validation test scripts as needed
• May administer and own multiple electronic systems including but not limited to managing user access, managing templates and reports, and working to resolve system issues.
• Assist with training/orientation for new staff
• Establish KPIs and metrics - Use and interpret qualitative/quantitative data to drive decision making
• Collaborate with team members to improve upon current product complaint procedures and documents in an effort to streamline the processes. Lead and drive improvements as required.
• Revise and approve standard operating procedures and other controlled documents as necessary
• Represent Seagen on cross-functional teams and initiatives
• May assist with regulatory inspections by acting as a scribe and/or document reviewer
• Represent Quality Compliance during Regulatory and partner audits
• Deliver awareness sessions with oversight by manager on various GMP topics internally and externally

Required Qualifications:

• 12+ years’ experience in GMP Quality
• Working knowledge of current industry practices and standards
• Experience with applicable software (e.g. electronic Quality Management Systems, data analytics, SharePoint Online, etc.)
• 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
• Innovative thinker and problem solver
• Ability to identify trends within data and apply insights to make recommendations and decisions
• Ability to bring recommendations to stakeholders for discussion and input

Preferred Qualifications:

• Bachelor’s degree in a scientific discipline or equivalent education and experience.
• Experience with commercial drug product operations including injectable parenterals, finished goods production, API and excipient manufacturing, and analytical testing
• Ability to function autonomously in a matrix model and in a team environment

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 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.

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Seagen

Seagen is an Equal Opportunity Employer

Submitted: 04/02/2021