Supervisor Manufacturing Compliance

Product Supply Operations Bothell, Washington


Description

Summary:

The successful candidate will support cGMP compliance at the North Creek Manufacturing Facility.  This position will partner with Seattle Genetics internal manufacturing groups to help maintain compliance with cGMP regulations as well as develop and facilitate training and continuous improvement methodologies that promote inspection readiness for a regulated commercial cGMP environment

 

Principal Responsibilities:

  • Perform manufacturing compliance oversight of the GMP manufacturing areas at the North Creek Manufacturing facility. Evaluate manufacturing equipment, systems, procedures, and operations for gaps; facilitate modifications and best practices to ensure manufacturing compliance to written procedures and regulations; drive ongoing improvements to ensure cGMP compliance and audit/inspection readiness
  • Partner with the Manufacturing and Quality Operations groups acting as a liaison ensuring alignment with quality directives and promoting internal manufacturing best practices and improvements to facilitate manufacturing readiness for internal and external quality audits/inspections. Participate directly in internal, external, and global health authority audits/inspections
  • Support Quality Training groups in ensuring manufacturing training curriculum and content is appropriate and up to date.  Present and defend the training program during audits/inspections
  • Provide support to the Manufacturing Operations group on significant deviations, CAPAs, change controls, and impact assessments. Also, provide mentorship and training along with the development of templates for generating consistent, high quality write-ups/investigations for less significant deviations, CAPAs, and change controls
  • Utilize Quality Risk Management and Operational Excellence principles to assist in risk-based decision making and drive continuous improvement for Seattle Genetics internal manufacturing.  Participate in risk assessments associated with the North Creek Manufacturing facility and assist in presenting and defending risk assessments during audits/inspections

 

Qualifications:

  • 7+ years of relevant biopharmaceutical industry experience
  • 3+ years direct GMP manufacturing experience of biological products
  • Management of direct reports highly desired
  • cGMP audit and compliance experience and recognized as a knowledgeable resource on a range of compliance topics is highly desirable
  • Demonstrated strong knowledge in cGMPs for drug substance manufacturing of biological products required
  • Demonstrated ability and experience working with cross-functional teams supporting biopharmaceutical manufacturing
  • Demonstrated ability to influence and engage indirect reports and peers
  • Knowledge of applicable business systems including: MRP, LIMS, EAM, and QMS desired
  • Excellent organizational skills and project management
  • Strong verbal and written communication skills and interpersonal skills
  • Proficient in Microsoft Office suite.  Experience with Articulate 360 training software is preferred
  • Able to work equally well as part of a team or independently

 

Education:

  • Bachelor of Science degree in chemical/biochemical or life sciences 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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