Associate Director, Quality Compliance

Location
Bothell, WA, United States
Posted
Dec 01, 2018
Ref
oi9j8fwC
Hotbed
BioForest
Required Education
Bachelors Degree
Position Type
Full time
Summary:

The Associate Director of Quality Compliance establishes and oversees the regulatory compliance status of Seattle Genetics, with a focus on the internal compliance status. This includes managing inspections of Seattle Genetics by Health Authorities, local Government Agencies, and Partners. Also in scope is the management of internal audits, Product Complaint management, and evaluation of external guidance and regulations that effect the business of Seattle Genetics, ensuring that the principles in these are incorporated into Seattle Genetics operations. Leads a team of QA personnel responsible for audits, inspection management, product complaint handling and regulatory knowledge management. This position liaises with Tech Ops Knowledge Management to ensure there is good visibility and awareness of emerging new or changing standards across the GMP network.

Responsibilities:
  • Serve as SGEN's business process owner for internal and external audits, inspection management and product complaint handling
  • Owns and administers the internal audit program covering all GMP activities and functions at all locations. Publishes periodic status reports reflecting the risk profile of GMP activities at Seattle Genetics
  • Manages the inspections of Seattle Genetics by Health Authorities and Customers including logistics, tracking and monitoring of the inspection, and leads the response process. Identifies SMEs and ensures the inspection related topics are adequately prepared for and addressed. Partners with other Quality functions to staff the inspection management team
  • 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
  • Provide expertise and guidance in interpreting government regulations and guidelines as they apply to SGEN products, policies and practices
  • Ensures Site Master File is implemented and maintained across all Seattle Genetics sites
  • 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
  • Provides strong leadership to the compliance team. Is 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. Is able to foster cooperation across multiple organizational functions and levels


Qualifications:
  • Requires a minimum of 15+ years experience in pharmaceuticals, biologics, or bio-pharmaceuticals, with 10+ years experience in Quality Assurance, including direct responsibility for Quality Compliance. At least 6 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
  • 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
  • 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


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.