Head of Global Quality

Summary:

Seattle Genetics is seeking a proven senior leader to head the company's Quality organization for Antibody Drug Conjugates, Antibodies, small molecules and other biologics. The role is a member of the executive leadership within Seattle Genetics and a core member of the Tech Ops leadership team. This role will lead the Quality Unit, in order to oversee and manage all aspects of Quality, both internally and externally, for established commercial products, a robust and expanding clinical stage portfolio, and associated with global product launches of the portfolio of products. The role is responsible for establishing and ensuring the operations of Seattle Genetics across the product portfolio and throughout the product lifecycle are commensurate with prevailing and emerging regulatory expectations and industry standards and are founded in strong science.

This individual leads a growing team of 110 professionals in the US and Europe, across the functions of Quality Control, Quality Compliance, Quality Systems, Quality Operations and Product Quality. The leader, in collaboration with key peers and stakeholders, create an environment that supports the values of the wider organization including; Learning culture, Speak up mentality, Risk-based thinking, Data-driven decisions and Continuous Improvement.

Responsibilities:

• Active member of the Seattle Genetics Tech Ops Leadership Team engaging with the other members to define the strategy for Tech Ops and ensuring the strategy is supported by Quality through right assignment of resources to provide sufficient quality oversight, timely resolution of issues, and early intervention to assure adequate compliance
• Direct the Quality Leadership Team and Extended Quality Leadership Team to define the strategy for the Quality Unit and create an agile and flexible global organization, ensure appropriate response to emerging trends and issues, and drive sustainable levels of quality throughout the Seattle Genetics organization
• Coach, mentor and lead the quality unit, ensuring appropriate organizational structure and levels of accountability to achieve rapid decision-making, streamlined and efficient execution of business strategy and plans, and effective escalation of issues
• In conjunction with Tech OPs, Research, Development and Commercial functions, provide SME input to and implement robust Quality Oversight systems and technical assessments for Due Diligence, initial qualification, and on-going relationships with Contract Manufacturers and Strategic Partners for clinical and commercial products. Ensure the oversight is in line with emerging regulatory and industry practices and standards
• Participate at a leadership level to provide strategic CMC guidance for commercial and clinical development teams and allocate resources to support program goals
• Provide leadership, input, guidance and expertise in establishing Quality Operations in x-US regions to support clinical and commercial efforts and ensuring robust, compliant patient supply
• Provide leadership and direction for significant events (deviation, adverse events, non-compliance status, other) that could adversely affect product quality, compliance status, or pose significant business risk. Maintain timely and clear cross-functional communication for quality-related topics, including progress on strategic priorities, resolution of issues, emerging trends regarding product performance and compliance. Support/supervise any authority communications and ensure that all BDPRs and other mandated reportings occur on time and with high quality of content
• Ensure that all CMC functions at all locations are meeting global standards and principles with respect to organization, personnel qualification, training, procedures, processes, performance and productivity
• Oversee the application and continuous improvement of quality system policies and procedures for assessment and oversight of governed operations, embedded in a culture of risk-based thinking, curiosity, and with an eye towards scalability and flexibility of processes to meet the evolving needs of the business
• Establish key objectives and metrics for evaluation of the effectiveness of the Quality management Systems and supporting functions and lead Quality Management Reviews including regularly scheduled Executive Committee Quality Reviews
• Develop and manage strategic plans and budgets for global quality operations
• Lead and develop a team of senior quality professionals allowing for career progression and succession planning
• Ensure that Quality programs and units support business objectives

Requirements:

• 20+ years of experience in related commercial and clinical Quality leadership covering GxP quality assurance in both tactical and strategic capacities
• Extensive background, experience and knowledge of the biologic drug development process. Additional experience in small molecule drug development is a strong plus
• Established expertise in GxP systems. Extensive knowledge of global regulations and standards
• Established experience in hosting and managing regulatory inspections from global health authorities including PAIs and periodic quality systems inspections
• Experience managing quality aspects of global biologics manufacturing network, particularly with managing CMOs
• Strong people leadership skills including the ability to effectively manage and mentor employees at senior levels (i.e. Director and above). Experience managing and leading an international-based staff, particularly in the EU, is a strong plus. Experience as a change agent is also desirable
• Proven ability to plan and budget resources effectively across multiple departments with competing priorities
• Other required leaderships skills are the ability to make tough decisions in a timely manner and the ability to influence executives on critical issues

Education:

• Must possess a degree in related life sciences technical field. An advanced, post-graduate degree is highly desirable

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.