Sr. Director, Quality Control

Location
Bothell, WA, United States
Posted
Nov 10, 2018
Ref
oGQN8fwb
Discipline
Quality, Quality Control
Hotbed
BioForest
Required Education
Doctorate/PHD/MD
Position Type
Full time
Summary:

The Sr. Director, Quality Control will have responsibility for the successful development and execution of quality control strategy and objectives of the Seattle Genetics Quality Control Function. This position is responsible for the oversight of Seattle Genetics testing sites (internal or external) globally, responsible for the testing and certification of Seattle Genetic products (both large and small molecule) and ensures the testing and performance of the QC Units meet the standards and expectations for QC operations in accordance with local and international requirements. The Sr. Director manages and develops QC staff for growth, focusing on optimum organization, performance, technical and leadership attributes, and succession planning.

This leader will be expected to effectively collaborate with key customers internally and externally, including Process Sciences and Analytical Sciences, Research, Manufacturing, CMOs/Contract Test Labs, CMC program teams, and other stakeholders to strategically manage and prioritize testing plans and schedules. This leader will also partner with Regulatory Affairs to ensure timely and accurate input into submission documents and responses to RFIs.

Responsibilities:
  • Responsible for leadership of QC functional areas that include: QC Units within the Seattle Genetics manufacturing facility and corporate headquarters, including microbiology and environmental monitoring, raw materials, product and in-process testing (Analytics (chemistry and biochemistry), Potency, Stability), and QC systems
  • Provide strategic and tactical leadership to the QC organization ensuring the execution of responsibilities within the Quality System
  • Implement and manage a GMP compliant laboratory control program in adherence to current FDA Guidelines, ICH, and foreign regulations in the areas of microbiology, biochemistry, chemistry, methods, validation and stability
  • Ensure harmonized practices across the global laboratory footprint
  • Ensure the testing of products is performed in a safe, compliant manner, meeting the regulatory requirements defined in relevant health authority submissions, cGMPs, and local Health and Safety requirements
  • Recruit, retain and develop QC talent responsible for the management of quality operations to ensure the compliance of all products
  • Develop performance goals and objectives for team; drive and monitor performance against objectives
  • Sustain employee engagement by creating a culture of excellence and an environment in which individuals and teams can excel and continuously improve
  • Drive compliance throughout the function and represent QC during regulatory inspections
  • Write and/or review assigned CMC sections for new and amended IND/IMPDs and license applications (MAA/BLA/NDA)
  • Develop and maintain strong and effective relationships with stakeholders
  • Lead team in strategy and oversight for addressing laboratory and site investigations and reports in response to OOS, invalid assays, aberrant trends/results, and studies
  • Assure quality risk assessments against regulatory compliance requirements for each manufacturing location are completed as well as on-going monitoring and management of the quality operations
  • With Operations partners, develop appropriate action plans to mitigate risks


Qualifications:
  • The ideal candidate for this position will have demonstrated in-depth experience of establishing and managing QC functions associated with the GMP production and testing of biologic products in both clinical and commercial settings
  • Minimum of 15 years of experience in the biotechnology or pharma industry with a primary focus on analytical QC for biologic products
  • Minimum of 10 years demonstrated track record of leadership and management of QC groups with people development and performance management skills
  • In-depth experience of QC analytical methods and regulatory/pharmacopeia requirements for biologic product testing and method validation


Education:
  • Educational background includes a degree in life science (Post-graduate degree in a related field is a plus)


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.