Senior Specialist Site Quality Compliance

Global Quality Bothell, Washington


Description

Summary: 

The Senior Specialist Quality Compliance is responsible for supporting site compliance activities at Seattle Genetics North Creek Manufacturing Facility. The position primary function will be to support the site Quality teams responsible for auditing (internal and external), inspection management, vendor management, and Quality Agreements in both a commercial and clinical setting. Additional responsibilities for this role include ensuring cross collaboration with corporate compliance, site compliance with regulations and internal procedures. The position must be able to interact with staff at various management levels and make presentations to internal and other customers. People management responsibility is not required.


Principal Responsibilities:

  • Support internal manufacturing site business processes related to auditing, inspection management/readiness, raw material vendor management and Quality Agreements related to internally manufactured activities
  • Partner with MSAT and Process Science to identify and qualify suppliers for Seattle Genetics. Perform assessment of suppliers and communicates risk level and qualification status to the organization
  • Support the internal audit program covering all GMP activities and functions at internal manufacturing site. Activities include scheduling, performing, and issuing audit reports and observation findings
  • Publishes periodic status reports, and metric data reflecting the risk profile of GMP activities at Seattle Genetics North Creek
  • Support site inspections of Seattle Genetics North Creek by Health Authorities and Customers including logistics (Audit preparations, Audit logistics (fulling requests, SME prep, etc.).  Partners with other Quality functions to staff the inspection management team
  • Maintaining a high level of inspection readiness at internal manufacturing site
  • Site coordinator for Quality Agreements with internal manufacturing vendors.  Partner with key stakeholder on Quality Agreement content ensuring consistency and compliance with Seattle Genetics standards
  • Partner on internal site vendor change notification process with change management staff as applicable
  • Updating and Maintaining the Site Master File as it relates to internal manufacturing site activities
  • Support SOP and Quality System development, maintenance and improvement as required
  • Experience with pharmacopeia, and raw material specification setting, and overall raw material safety assessment (i.e. TSE/BSE, Viral)
  • Other Quality/compliance activities as required

Required Qualifications:

  • Bachelor’s degree in a scientific discipline or equivalent with 10 years or more relevant industry experience in a regulated pharmaceutical, biologics, or biopharmaceutical environment
  • Demonstrated organizational, problem solving and decision-making skills
  • Strong negotiating, influencing and PM skills
  • Excellent communication and interpersonal skills with ability to interface to all levels within organizations
  • Formal training and experience in regulatory compliance auditing and supplier quality management

 

Preferred Qualifications:

  • Experience with clinical and commercial pharmaceutical/biopharmaceutical products
  • Ability to communicate to drive action and inform of project status
  • Ability to lead meetings and to provide and report metrics
  • Experienced with various electronic quality management systems
  • Strong experienced with MS-Word, Excel, Project, PowerPoint, SharePoint, OneNote, and Visio
  • Excellent technical writing, communication, and analytical skills

As the leading employer in our industry in the Pacific Northwest, Seattle Genetics 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 Seattle Genetics, please visit www.seattlegenetics.com.

Seattle Genetics 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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