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Manager, Quality Compliance – Audit Program Management

companySeagen
locationBothell, WA, USA
PublishedPublished: 12/8/2023
Full Time

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 – Audit Program Management is responsible for day-to-day planning, maintenance, and compliance of the Seagen internal and external audit programs.  Within the Audit Program Management are the execution of GMP and GDP external audits of Seagen’s CMO’s, Partners, Suppliers and Service Providers.  The internal program is responsible for the execution of audits of quality system, functional area programs, and internal manufacturing site(s).

Principal Responsibilities:

  • Development of annual audit plans per internal procedures and using the eQMS system (Veeva)
  • Manage the influx of new audit requests and identify the strategy for delegation and completion.
  • Key Point of Contact for the Veeva Audit Program Module include maintenance of organizational data within the system, creating of records, and monitoring status’.  Responsible for the development of electronic reports to monitor progress and completion of audits and CAPA records
  • Manage oversight and coordination of audits and audit documentation with External Auditors / Audit Service Providers.  Act as liaison between Seagen and external parties. 
  • Manage the oversight and closure of CAPA’s with internal stakeholders and external parties
  • Determine and document decisions on audit challenges including escalation to Senior Management
  • Responsible for the verification of key performance metrics and the reporting
  • Write, revise and review audit program procedures, work instructions and tools
  • Collaborate with Supplier Quality Management team to build sustainable risk-based supplier programs include classifications, audit frequencies, and qualification status’. 
  • Proactively evaluate systems and processes to identify improvements with a focus to simplify and standardize.  Lead and drive new processes and tool in support of sustainable growth within the audit program
  • Represent Seagen during external and internal audits, and on cross-functional teams and initiatives
  • Schedule, prepare, and conduct audits in support of GMP activities including agendas, responses, reports, statuses, and audit closure.  Lead post-audit activities and follow up on any vital corrective and preventive actions
  • Collaborate with stakeholders on audit preparation and post audit communications to mitigate risks
  • Lead post audit activities and follow-up on corrective and preventive actions
  • Assist with training/orientation for new Quality Auditing staff
  • May assist with regulatory inspections or other duties as assigned

Required Qualifications:

  • BS degree or equivalent in scientific, quality-related field, biology, chemistry, or pharmaceutical studies, or an equivalent combination of education, training and experience
  • 12+ years’ experience in the pharmaceutical biotech industry with responsibilities in Quality
  • Ability to interpret policies, standards, and regulations
  • 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 global regulations and standards and 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 drive for results oriented.  Ability to manage multiple urgent requests in a fast-paced environment
  • Well organized and efficient with ability to manage multiple priorities
  • 25% domestic and international travel required

Preferred Qualifications:

  • 5+ years prior auditing experience as a GMP Auditor in the life science industries. 
  • ASQ CQA Certification a plus
  • Management of electronic audit documentation programs such as Veeva, Trackwise or other industry platforms
  • Development of electronic reporting capabilities such as PowerBI, Tableau or other industry tools
  • Execution of audits of CMO’s, API Manufacturers, Raw Material Suppliers, Distributors and Warehouses and Contract Testing Labs
  • Execution or support of Due Diligence, Qualification, Routine, For-Cause and Focused audits
  • Experience with commercial drug product operations including injectable parenterals, finished goods production, API and excipient manufacturing and analytical testing

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. 

The hiring pay range for this position is $121,000 to $156,000 per year based on skills, education and experience relevant to the role. Other components of total compensation include a competitive equity grant at the time of hire and an annual bonus.

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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