Change Planning Specialist

Product Supply Operations Bothell, Washington


Description

Summary: 

The principal objective of the Change Planning Program Specialist (PPIM) is to ensure continuous supply by planning for post approval changes throughout Seagen supply chain. The individual in this role will be responsible for the day-to-day operations of the Change Planning business process across all programs. An important element of the job is to develop and ensure changes are managed through the business process and developed for successful implementation prior to entering into the Quality Management System. This individual will have leadership and administrative responsibilities for change planning and includes training of change owners and functional support.  Responsible for reporting change status to CMC and Partners, as necessary. Must have a broad understanding of how functional areas interact to support product supply, including regulatory and change management areas. Experience in a regulated industry is preferred. This position will closely work with all internal and external resources to minimize impact of changes to supply and production plans. This position is a key interface between manufacturing operations, Quality, CMC teams, Regulatory, and Supply Planning.  This position must be able to build and maintain strong partnerships with all internal and external stakeholders and lead discussion, problem solving efforts and support process improvements to ensure supply goals are met or exceeded. 

Principal Responsibilities: 

  • Responsible for daily management and coordination of change requests through Change Planning business process to support continuous improvement and regulatory commitments for Seagen’s supply chain 
  • Maintains reports of changes and lead discussions to plan for changes 
  • Communicates change plans across functions and assists appropriate teams to ensure successful implementation 
  • Lead cross-functional team to manage change planning process to ensure minimal impact of changes 
  • Oversee and report high level timelines for implementation of changes 
  • Work closely with Regulatory to ensure appropriate supply is approved for market 

Qualifications: 

  • Minimum 5+ years of experience in change management, project management, planning, scheduling, and/or supply planning in biotech/pharmaceutical industry 
  • Experience in a FDA regulated atmosphere 
  • Experience in working within matrix organizations and works effectively with cross-functional and multi-location / multi-cultural teams 
  • Exhibits creativity in adapting to changing situations 
  • Excellent verbal and technical written communication skills, excellent interpersonal skills, and negotiation skills are essential 
  • Attention to detail and organizational skills are critical to success of organization 
  • Experience working with an integrated enterprise level planning system. (QMS, SAP, Oracle etc.) 
  • Works only under general direction 
  • Independently determines and develops approach to solutions 
  • Minimal travel (< 5%) 

Education: 

  • BS/BA Degree in a business or life science field preferred 

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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