Senior/Executive Director, Quality

Quality Seattle, Washington United States


Description

Why Work for Us?

Innovation. Act with Integrity. Collaboration. Embrace Diversity. Care

We come from many countries, cultures, races, ethnicities, abilities and nationalities. We bring our passions including singing, biking, swimming, dancing, cooking, volunteering, parenting, coaching and much more! We are proud of our nearly equal balance of men and women and strengthened by our non-binary and transgender team members. Every employee belongs.

We offer challenging career opportunities, competitive benefits and an environment that recognizes and rewards performance.

Company Description

Zymeworks is a clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of next-generation bispecific and multifunctional biotherapeutics, initially focused on the treatment of cancer.  Zymeworks’ suite of complementary therapeutic platforms and its fully-integrated drug development engine provide the flexibility and compatibility to precisely engineer and develop highly-differentiated product candidates.

Zymeworks is seeking a highly motivated senior quality leader who is looking to grow their career with our company. This position will report to the Chief Operating Officer, will work in Seattle, Washington, and ensure that Zymeworks maintains a culture of quality and compliance with all regulatory requirements, and will focus on optimizing quality, ensuring compliance and reducing risk through oversight of the Company’s Quality Management System and processes. This leader ensures that the organization is trained to the highest standards of quality excellence and technical competency utilizing best in class processes and practices and will lead a mission critical business function with reach across the company.

As a condition of employment, Zymeworks requires all employees to be fully vaccinated against Covid-19 and provide verification of such.

Key Responsibilities

  • Works collaboratively across the organization to drive the quality culture.
  • Support and integrate into the Company’s Quality organization, and relationships with organizational staff to design Quality programs to support the organization’s needs.
  • Responsible for overseeing and maintaining the Zymeworks’ quality management system including Document Control and Training.
  • Ensures that the Quality organization executes the required oversight of a harmonized, company-wide quality organization, including functions working to GLP, GCP, GMP and GVP and provides guidance to these functions to facilitate compliance.
  • Supports product regulatory submission requirements specifically related to the input required on either proprietary or client related products.
  • Develops, implements, and monitors Quality programs, policies and procedures to ensure compliance with GLP, GCP, GVP and GMP standards as defined by US FDA, EMA, ICH and other regulatory body guidelines.
  • When applicable, responsible for final approval on site level regulatory inspection response.
  • In conjunction with Regulatory leadership, establishes and maintains a positive working relationship with US FDA and other regulatory authorities.
  • Represents the company, in conjunction with cross-functional peers, on quality and GLP, GCP, GMP and GVP compliance issues.
  • Evaluates all current Quality systems and processes and recommend and implement appropriate enhancements to ensure the achievement of Zymeworks’ long-term objectives.
  • Conducts monitoring of site level quality indicators and the quality systems efficiencies.
  • Supports the development of action plans to mitigate areas of concern and assesses opportunities to maintain regulatory compliance while streamlining quality operations.
  • Monitors quality performance indicators including, but not limited to, deviation investigations and closure; change control; CAPA closure; product release; trend analysis. Ensures that appropriate action plans to resolve issues are developed and executed.
  • Empowers the GMP Quality Assurance group to disposition production lots at contract manufacturing facilities, for human use.
  • Supports and leads the GCP Quality team in ensuring that established ethical and scientific quality standards, required training and policies are consistently applied across its global clinical trials networks.
  • Provides the route of escalation of GLP, GCP, GMP and GVP non-compliance to the Chief Operating Officer and ultimately to the Chair and Chief Executive Officer.
  • Ensures commercial products are maintained and released to market in compliance with their relevant license(s).
  • Implements continuous improvement initiatives to drive Quality programs and ensure maximum productivity. 
  • Manages the development of quality assurance oversight systems and goals and implements specific objectives to ensure oversight systems are adequate and goals are realized.
  • Leads the establishment of key metrics for monitoring quality system effectiveness and to drive higher standards of quality execution. Performs analysis of quality data sources to draw conclusions, identify risks, and propose possible solutions.
  • Provides functional leadership and oversight for senior projects on quality strategy, emerging trends and best practices while providing oversight for quality management activities.
  • Facilitates the sharing of best practices through management review process and provides technical assistance to projects in quality and process improvement related areas.
  • Develops strategies and solutions for quality functions, and functions as a strategic business partner, with regards to business development opportunities.

Qualifications and Education

  • 15+ years of biotechnology industry experience, with an emphasis on Quality Assurance systems and leadership in a biopharma/biotech environment with early and late-stage products. Advance scientific or technical degree in a related field is considered beneficial.
  • Extensive experience with quality systems directly related to biologics manufacturing cGMP
  • Extensive experience providing oversight to Document Control and Training activities
  • Extensive experience with GCP, GLP, GVP and GMP regulated activities
  • Relevant experience related to manufacturing and clinical activities incorporating antibody-drug conjugates (“ADCs”), cytotoxic anti-tumor biologics, and immune-oncology is preferred.
  • Experience in managing quality activities in line with, and interacting with, US FDA, China FDA, Health Canada, EMA, and PMDA. Other global regulatory experience will be considered beneficial.
  • Experience with GMP, GLP, GVP and/or GCP regulatory inspections
  • Experience and success in leading a company through BLA pre-approval and post-approval inspections
  • Experience with developing and managing budgets
  • Prior experience performing at a high level in Regulatory Agency Inspections as a subject matter expert
  • Successful track record of building, leading, and mentoring successful cross-functional Quality teams

Knowledge, Skills and Abilities

  • Thorough understanding of drug development from early stage to commercialization
  • Thorough knowledge of FDA and EU cGMP/CGP/GLP/GVP regulations and guidance, including an in-depth knowledge of standards issued under the ICH guidelines
  • Proven experience being part of a multi-functional team building and advancing a pipeline of innovative treatments through to successful INDs.
  • Strong interpersonal and influencing skills
  • Ability to analyze risk levels and develop and recommend paths to minimize risk while still achieving objectives
  • Ability to plan and budget at a strategic level
  • Proven leadership skills with a record of experience and success in building and engaging a high performing team including the ability to collaborate, take initiative and work as a team leader and as a member of a team
  • Good analytical and problem-solving skills
  • Excellent verbal and written communication skills

NOTE TO EMPLOYMENT AGENCIES: Zymeworks values our relationships with our Recruitment Partners. We will only accept resumes from those partners whom have been contracted by a member of our Human Resources team to collaborate with us. Zymeworks is not responsible for any fees related to resumes that are unsolicited or are received without contract.

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