Senior Director Of Quality REQ 20002

Lyell Immunopharma, Inc. Seattle , WA 98101

Posted 3 weeks ago

The Senior Director of Quality is responsible to build and lead the Quality Assurance (QA) and Quality Control (QC) functions across all regulated programs and processes. The Senior Director and their Quality team will support all of Lyell GCP, GLP and cGMP (GXP) functions including, but not limited to, internal and external manufacturing and testing, non-clinical studies, and clinical trials. The individual will serve as a key leader of the Technical Operations team and will be responsible for overseeing the development and implementation of Lyell quality management systems and will establish Strategic Quality Objectives in support of development programs and corporate goals. This position will drive and cultivate a culture of quality throughout Lyell to support compliance with all applicable regulatory requirements, guidelines, and corporate standards, policies, and procedures.

Essential Functions:

  • Quality Assurance
    • Create and optimize Lyell Quality Management System (QMS) processes including Change Control, Document Control, Risk Management, Deviations, CAPA, Training, Product Complaints, Audits, and Vendor Qualification.
    • Ensure alignment of QMS across Lyell sites.
    • Identify, select, implement and validate scalable software to support Quality systems.
    • Lead the development and reporting of Quality metrics and periodic reporting depicting GXP compliance trends and any areas of risk with associated mitigation plans.
    • Serve on the Lyell cGMP Facility Project Team as a key stakeholder and Quality lead.
    • Work collaboratively with leaders from Manufacturing, Engineering, Process Sciences and Supply Chain on all aspects of facility design, construction, qualification, start-up and routine cGMP manufacturing.
    • Ensure timely review and approval of critical cGMP documentation.
    • Develop and create Lyell Clinical QA infrastructure and strategic direction in conjunction with Clinical Operations.
    • Train/coach Clinical QA and/or other QA personnel in preparing, conducting, and reporting audits of investigational sites, Service Providers, CRO's, and other types of audit as required.
    • Provide guidance on GCP compliance matters within clinical study teams.
    • Establish and maintain adequate GXP training programs to support aggressive corporate growth plan.
    • Serve as an escalation point for corporate quality issues including investigation, recalls, deviations, CAPA, change controls, audits, validation and training.
    • Ensure that the company, its contractors and vendors are prepared for FDA and other Health Authority audits. Coordinate and host all GXP inspections.
    • Develop plans and programs to support continuous quality improvement.
    • Develop and effectively manage department annual operating budgets for QA.
  • Quality Control
    • Oversee the development and implementation of QC procedures and policies related to Lyell and vendor cGMP operations.
    • Ensure that Lyell QC laboratories are maintained at a high standard of cleanliness and organization, equipment maintenance and calibrations are performed, and cGMP documentation is completed, reviewed, and archived in a timely manner.
    • Work with key stakeholders including QC lead to develop execution plans for increasing capacity and throughput of QC operations.
    • Collaborate to identify and mitigate risks in QC operations that could negatively impact the quality of patient therapies.
    • Support corporate drive to implement Lean principles to increase quality and productivity.
    • Develop and effectively manage department annual operating budgets for QC.
  • Provide Leadership
    • Provide exceptional leadership skills to the organization including hiring, mentoring and developing Quality staff.
    • Develop a vision, strategy, and plans that are innovative, forward-thinking and based on sound business judgement, considering scalability and sustainability.
    • Use strong communication and teamwork skills to build strong relationships with stakeholders.
    • Champion implementation of new technologies and systems.
    • Ensure a culture of strong GXP compliance and risk management across Lyell.
    • Role model Lyell Values and Lean Leader principles to establish a continuous improvement culture.

Requirements

Preferred Experience:

  • A minimum of 15 years of work experience in the biotechnology industry with at least 10 years of progressive responsibility in Quality. 5 years must be in management or leadership role.
  • Expert knowledge of FDA, EMA, MHRA and ICH regulations and guidelines.
  • Experience in hosting domestic and global Health Authority inspections.
  • Experience working with US and EU CMOs, suppliers, CROs and clinical sites.
  • Experience with assessing new technologies in fast-paced, learning organization; preferably in a cross-functional setting where impact of new technologies is evaluated across research, development and commercial organizations.
  • Experience is all phases of drug development; experience with cell therapy desirable.
  • Extensive working knowledge of GXP regulations and experience interacting with regulatory agencies.
  • Demonstrated ability to build effective, efficient teams, and drive change within organizations.
  • Fast learner, adaptable, with enterprise viewpoint and excellent cross-collaboration and inter-personal skills.
  • Motivated to work independently as well as in teams.

Preferred Education:

  • BS/MS in a scientific discipline or related discipline.

Preferred Additional

Skills:

  • Must have excellent change management, oral and written communication skills.
  • Ability to work independently and collaboratively among cross-functional teams.
  • Ability to work efficiently, prioritize workflow, meet deadlines and balance competing priorities.

Benefits

At Lyell, we believe that highest performing teams include people from a wide variety of backgrounds and experiences who respectively challenge each other. We are committed to building an open, diverse and inclusive culture for all employees.

Weve learned from experience that some of the best people dont always match our requirements perfectly if youre interested and think you could fit, please dont hesitate to apply.

Lyell is proud to be an equal opportunity employer and does not discriminate on the basis of race, color, citizenship status, national origin, ancestry, sex, sexual orientation, age, religion, creed, physical or mental disability, medical condition, marital status, veteran status or any other characteristics protected under applicable federal, state and local laws.

If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited or unable to access or use this online application process and need an alternative method for applying, please contact us via our company website.

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Posted 3 months ago

VIEW JOBS 12/6/2019 12:00:00 AM 2020-03-05T00:00 <p> The Senior Director of Quality is responsible to build and lead the Quality Assurance (QA) and Quality Control (QC) functions across all regulated programs and processes. The Senior Director and their Quality team will support all of Lyell GCP, GLP and cGMP (GXP) functions including, but not limited to, internal and external manufacturing and testing, non-clinical studies, and clinical trials. The individual will serve as a key leader of the Technical Operations team and will be responsible for overseeing the development and implementation of Lyell quality management systems and will establish Strategic Quality Objectives in support of development programs and corporate goals. This position will drive and cultivate a culture of quality throughout Lyell to support compliance with all applicable regulatory requirements, guidelines, and corporate standards, policies, and procedures. </p><p><strong>Essential Functions:</strong></p><ul><li><strong>Quality Assurance</strong></li></ul><ul> <ul> <li>Create and optimize Lyell Quality Management System (QMS) processes including Change Control, Document Control, Risk Management, Deviations, CAPA, Training, Product Complaints, Audits, and Vendor Qualification.</li> <li>Ensure alignment of QMS across Lyell sites.</li> <li>Identify, select, implement and validate scalable software to support Quality systems.</li> <li>Lead the development and reporting of Quality metrics and periodic reporting depicting GXP compliance trends and any areas of risk with associated mitigation plans.</li> <li>Serve on the Lyell cGMP Facility Project Team as a key stakeholder and Quality lead.</li> <li>Work collaboratively with leaders from Manufacturing, Engineering, Process Sciences and Supply Chain on all aspects of facility design, construction, qualification, start-up and routine cGMP manufacturing.</li> <li>Ensure timely review and approval of critical cGMP documentation.</li> <li>Develop and create Lyell Clinical QA infrastructure and strategic direction in conjunction with Clinical Operations.</li> <li>Train/coach Clinical QA and/or other QA personnel in preparing, conducting, and reporting audits of investigational sites, Service Providers, CRO's, and other types of audit as required.</li> <li>Provide guidance on GCP compliance matters within clinical study teams.</li> <li>Establish and maintain adequate GXP training programs to support aggressive corporate growth plan.</li> <li>Serve as an escalation point for corporate quality issues including investigation, recalls, deviations, CAPA, change controls, audits, validation and training.</li> <li>Ensure that the company, its contractors and vendors are prepared for FDA and other Health Authority audits. 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Seattle WA

Senior Director Of Quality REQ 20002

Lyell Immunopharma, Inc.