Senior Manager, Site Quality Compliance/Systems

Employment Type

: Full-Time

Industry

: Miscellaneous



Description

Summary: 

The Senior Manager Site Quality Compliance/Systems is responsible for overseeing site compliance for Seattle Genetics North Creek facility in alignment with Corporate Directives. The position leads a site Quality team responsible for auditing, inspection management, raw material vendor management, product complaint investigations, Quality Agreements and Quality Systems.

The Senior Manager role is primarily focused on providing site Quality Compliance leadership while representing the role and responsibility of site Compliance in collaboration with Corporate Quality Compliance.

This position is responsible for developing staff expertise and effective decision making and reports to the North Creek Quality.

Principal Responsibilities:

  • Serve as internal manufacturing site business process owner for auditing, inspection management/readiness, raw material vendor management/Quality Agreements, and product complaint investigations related to internally manufactured products
  • Evaluates and manages site supplier/vendor qualification program. Partner with Technical Operations to identify and qualify suppliers for Seattle Genetics North Creek site. Administers the routine assessment of suppliers and communicates risk level and qualification status to the organization. Establishes and evaluates questionnaires for on-boarding suppliers, supplier risk assessment program
  • Oversee coordination of all site vendor complaints including partnering with complainant group on content and acceptability of responses and any associated CAPA
  • Owns and administers the self-inspection program covering all GMP activities and functions at internal manufacturing site. Publishes periodic status reports, and metric data reflecting the risk profile of GMP activities at Seattle Genetics North Creek. Ensure timely issuance of self-inspection reports, tracking responses and audit CAPA
  • Manages site inspections of Seattle Genetics North Creek by Health Authorities and Customers including logistics, tracking and monitoring of the inspection, and leads the response process. Identifies SMEs and ensures inspection related topics are adequately prepared for and addressed. Partners with other Quality functions to staff the inspection management team
  • Ensure high level of inspection readiness at internal manufacturing site at all times in collaboration with applicable SMEs and CMC teams
  • Implement and manage the process of ensuring effective identification, control and management of regulatory and operational requirements, ensuring that all applicable law, regulations and current standards are implemented within the Seattle Genetics systems and processes
  • Responsible for ensuring Quality Agreements are implemented with all required raw material suppliers/vendors. Partner with key stakeholders on Quality Agreement content ensuring consistency and compliance with Seattle Genetics standards
  • Partner on internal site vendor change notification process with change management staff
  • Ensure the Annual Product Review/Product Quality Review for internally manufactured commercial products are conducted in the required timeframe, provide the appropriate level of detail and required trend analysis
  • Ensures Site Master File is implemented and maintained related to internal manufacturing site
  • Develops and analyzes metrics for areas of responsibility
  • Builds a strong Regulatory Intelligence network, in collaboration with TOPS Knowledge Management. Partners with other Quality and TOPS leaders to enhance standards processes and practices by incorporating regulatory knowledge and experience (gained through involvement with regulatory intelligence, due diligence and integration, best practice sharing, industry trade groups) into daily business
  • Site Quality point of contact for management of investigations related to product defects, complaints, recalls, Biological Product Deviation Reports and Health Authority notifications for internally manufactured products. Active participant in mock recall drills
  • Provides strong leadership to the compliance team. Able to recruit, develop and retain first class self-driven talent into the compliance function. Is a collaborative partner with other Quality and TOPS leaders. Able to foster cooperation across multiple organizational functions and levels
  •  Qualifications:

  • 10+ years’ experience in Quality Assurance, including responsibility in Quality Compliance. At least 3 years of experience in people management
  • Demonstrated ability to lead, develop and build GMP Quality and Compliance infrastructure and support Regulatory activities and obligations to Health Authorities
  • Proven leadership skills and experience in meeting long term business and Quality objectives by aligning team strategy and vision with corporate business goals and objectives
  • Expertise in GMP compliance and FDA/EMA regulations and proven track record of identifying and implementing updates to internal policies and practices based on changes in the regulatory landscape
  • Successful implementation of Quality Risk Management tools and processes with proven track record of leveraging modern risk management principles in decision making and identifying and implementing process enhancements
  • Skilled at guiding technically oriented business objectives within the framework of regulatory guidance and company quality systems, internally and externally, to achieve value-adding outcomes
  • Established and innovative problem solver
  • Has a bias for action and displays a sense of urgency. Must possess strong skills in leadership and communication
  • Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships
  • Proven leadership ability to carry out difficult decisions in a logical, rational manner, and demonstrated ability to work as a senior team member and to engage and influence team members in a matrixed environment
  • Travel (US domestic and overseas) up to 10%, or as needed
  •  Education:

  • Bachelor’s degree in a scientific discipline or equivalent
  • 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.


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