Senior Manager Quality Compliance

Global Quality Bothell, Washington


Description

Summary: 

The Sr. Manager, Quality Compliance develops and maintains corporate compliance programs in alignment with corporate directives. The position is responsible for Inspection Management and Readiness, Quality Culture and Recalls.

Principal Responsibilities:

  • Develop and implement Corporate Inspection Management and Readiness programs
  • Oversee the regulatory inspection process and provide inspection support with your team, which may include presentations and documentation review
  • Functional responsibilities include hosting and management of regulatory inspections and corporate GMP audits
  • Develop, lead, and execute inspection readiness activities
  • Accountable for the response process and follow up on mitigation activities, including coordination and interface with affiliate sites as required. Help define and ensure corrective and preventative actions are implemented in a robust and timely manner. Specifically, Compliance
  • Responsible for site and country affiliate training on Inspection Management and Readiness programs
  • Provide leadership to cross-functional team members
  • Establish and manage a Global Quality Culture program
  • Develop and implement Recall process for all Seattle Genetics markets
  • Support timely preparation of the APQRs and improvement action plans as necessary, including annual updating of the Site Master File
  • Ensure meaningful metrics are established and communicated for area of responsibility
  • May conduct audits and support vendor management activities
  • Identify process improvements in the Quality Compliance department to ensure programs remain compliant with internal procedures and federal and local requirements for Seattle Genetics markets
  • Lead and participate in risk assessment, investigation activities and decision-making for compliance programs
  • Manage staff responsible for Inspections/audits, Quality Culture and Recalls

Required Qualifications:

  • 14+ years’ experience in GMP Quality Assurance including responsibilities for Quality Compliance
  • 4 years supervisory experience
  • Demonstrated ability to lead, develop and build program infrastructure to support compliance activities and obligations to Health Authorities
  • Demonstrated leadership in Quality & Compliance discipline and in-depth knowledge of global health authority regulations and requirements, with the ability to effectively translate and communicate these requirements into effective global procedures/policies
  • Must possess strong leadership skills to work cross functionally and build strong business relationships with cross-functional teams and leadership
  • Thorough knowledge of FDA/EMA regulations and an ability to quickly understand and interpret new market requirements
  • Must be capable of assessing compliance requirements using sound judgement and decision-making skills
  • Must possess strong communication skills verbally and written
  • In depth knowledge and experience with quality systems, corrective action and preventative action system, and other key tools for managing quality compliance assessments

 Preferred Qualifications:

  • Bachelor’s degree in a scientific discipline or equivalent education and experience
  • 7+ years prior experience managing a Regulatory Inspections, Recalls and Quality Culture initiatives
  • Effective at leading inspections including playing key roles as well as developing inspection responses for multiple regulatory markets
  • Prior auditing experience as a lead auditor for GMP audits

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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