Director, Product Quality

Seattle Genetics   •  

Bothell, WA

Industry: Pharmaceuticals & Biotech

  •  

15+ years

Posted 61 days ago

This job is no longer available.

Description


Summary:

The Director of Product Quality (Product Quality Steward) serves as a quality expert for the product during clinical development all the way through post-commercialization, and is responsible for making quality-related decisions and serving as a liaison between the project team and other quality functions. This role is the single point of contact for all quality issues associated with the development and commercialization of one or multiple late stage programs. This role serves as the primary Quality point of contact with the Development Partner and participates in all joint discussions, planning and issue resolution between the Quality parties as they relate to TV. This role is a key member of the CMC subteam, providing efficient and effective strategic and quality input into CMC related activities and associated quality decisions. In addition to a later stage program, this position is also responsible for providing Product Quality support for 1-2 early stage clinical programs (TBD).This position reports to the Global Head of Quality for Seattle Genetics and laisses with the wider QA organization to manage the program-related quality activities related to the Quality function and obtain Quality resources to manage the tasks.


Responsibilities:


Stewardship– for the product(s) assigned:

  • Lead the Product Quality Work Group
  • Oversee the overall quality of the product development process in collaboration with the Development/commercialization Partner
  • Act as Quality expert for the assigned projects; provide expert quality guidance for internal and external parties related to GMP quality standards, relevant quality guidelines, regulations and requirements for manufacturing and testing, including expectations for SGEN products in both early and late clinical phase, in preparation for commercialization
  • Provide guidance, support and leadership for implementation of quality standards, processes, and strategy for assigned products internally and with strategic partners
  • Provide strategic input to the CMC subteam on all aspects of the quality standards, risks and approached to support rapid development timelines with a high probability of success with respect to product quality
  • Create and maintain a product specific Quality Risk Analysis (QRAs)
  • Develop and maintain the specified Quality documents that support the partnership in the various regions per the QAA and strategic work plans
  • Identify, communicate and mitigate product and process risks
  • Monitor all critical variables and key variables as appropriate, providing advice as to relevant tools and statistical analysis, and providing the Quality Approval of characterization reports, stability reports, validation documents, and other key product development reports
  • Provide the Quality input to all submission documents, looking for technical accuracy and conformance to previous commitments or standards
  • Ensure inspection readiness for all process related aspects of assigned products and participate in inspections as the Product Quality SME
  • Provide input into the annual Product Quality Review
  • Track and evaluate product performance, trending, detect issues, implementation of CAPAs
  • Lead / support root cause investigation of process failures, initiate and lead product improvement projects, involving cross-functional teams
  • Provide the Quality in-put to identification of the CQAs and CPPs
  • Ensure an appropriate process control strategy based on CQA and where necessary on CPP, CMA is in place, support improving the control strategy where applicable
  • Assess impact of technical changes, assess their technical feasibility and determine scope / design of technical batches, challenge technical risk and business benefit of technical changes proposed
  • Contribute to registration strategy and support registration activities
  • Own and establish the team for creation of the Product Specification File (if not already in place). Manage the life-cycle of the PSF
  • Quality SPOC and SME for the creation of the Registration Core Technical Document content
  • Identifies additional resources and subject matter experts from the Quality organization to manage content of specific sections. Oversees the timely and correct completion of the sections and harmonizes content for all regions
  • Support development product commercialization from a QA perspective, including review of IND/IMPD as well as commercial NDA/BLA and ex-us regulatory filings
  • Partners with Regulatory CMC to address requests for information and questions received from all submission activity


Qualifications:

  • Requires a minimum of 15+ years experience in pharmaceuticals, biologics, or bio-pharmaceuticals, with 10+ years experience in a quality related role or a product development role with responsibility for registration activities
  • At least 10 years of experience in management with at least 3 years of experience managing quality topics in an out-sourced manufacturing environment
  • Expertise in Global requirements/standards for product registration and life-cycle management of product quality
  • 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
  • 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 30%, or as needed


Education:

  • BS or equivalent in Chemistry, Biology, or a similar life science. Advanced degree is a plus