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Astellas Pharma Associate Director, Clinical Quality Assurance in South San Francisco, California

Why Work for Us

Are you ready to use your experience and expertise to make an impact on patients' lives? Astellas Gene Therapies is a biotechnology company developing new genetic medicines for rare, life-threatening diseases. We are working urgently to progress our medicines and need additional team members to help us do so. Because our mission is so important, our values are to: Be BOLD: Find a Way, Care Deeply, and Get Stuff Done. If you'd like to be a part of this important mission, please apply to join our team.

About Astellas Gene Therapies

Astellas Gene Therapies is developing genetic medicines for patients with rare, life-threatening diseases. Based on our innovative approach to developing genetic medicines, as well as our industry-leading internal manufacturing capability and expertise, we have become the Astellas Center of Excellence for the newly created Genetic Regulation Focus Area. We are currently exploring three gene therapy modalities: gene replacement, exon skipping gene therapy, and vectorized RNA knockdown, with plans to expand our focus and geographic reach under Astellas. We are based in San Francisco, with manufacturing and laboratory facilities in South San Francisco and Sanford, North Carolina.

Our Values:

  • Be BOLD (Find a Way)

  • Care Deeply -- for our patients, each other and our work

  • #GSD (Get Stuff Done)

What is the catalyst for you in your professional career? Are you ready to be a part of a bold, innovative company, to make a change and to make a difference? Listed below is a current opening for a smart, driven, experienced, and just plain nice individual who wants to join us and be a part of our journey.

The Role

  • MBA or similar

  • Experience with product launch in the biotech space

  • Oracle ERP and Adaptive planning experience

  • Experience in a high growth environment. Able to quickly traverse between strategic and detail oriented operational topics. Ability to prioritize, make rapid decisions and adjust to changing needs and timelines

Primary Responsibilities

  • Develops strategy and executes the direction for CQA's approach under the guidance of the Executive Director/Senior Director/Director, CQA. In collaboration with the CQA Management Team and stakeholders, implements the development of this approach to ensure an effective quality program which complies with regulatory requirements and stakeholder expectations. Provides the leadership to drive the development, communication, implementation, maintenance and execution of standards and processes within the function and communicates to relevant stakeholders.

  • Continuously evaluates the strategic approach, drives changes in the quality, vendor qualification, and audit program to meet changing needs of the organization, regulatory environment and industry best practices.

  • Creates and implements the appropriate strategic risk-based support model for assigned project(s). Represents CQA as a Global Quality Lead (GQL) for AGT clinical projects. Represents CQA on Core and extended teams.

  • Develops, implements, and executes processes to support inspection readiness throughout the study lifecycle and in preparation for an anticipated regulatory inspection(s)

  • Supports vendor governance for key clinical vendors

  • Develops and implements processes for identifying, managing, and documenting clinical quality and noncompliance incidents and CAPAs

  • Development of short and long-term risk-based quality strategies in support of AGT development programs based on current regulatory interpretations and drives their implementation locally and globally as appropriate

  • Collaborates within CRQA and AGT functions to develop, manage, and execute the global audit and oversight program.

  • Manages assessments, evaluations, development and maintenance of the audit schedule for internal and external audits (e.g. investigator sites and vendors). Responsibilities include:

  • Assessment of vendor tiers and risks (initial and ongoing as needed)

  • Conduct of Investigator Site, vendor, and internal audits.

  • Review and approval of audit plans, reports, responses, and associated documents

  • Resource identification, contracting, and management of clinical contract auditors

  • Drives consistency across projects, processes and organization by (not limited to):

  • Leading process improvement and operational excellence activities across CRQA and AGT.

  • Supporting and executing Due Diligence and/or post acquisition activities.

  • Supporting inspection readiness activities

  • Enhancing stakeholder relationship to ensure compliance and consistency of regulate activities and associated processes

  • Triage of new regulatory requirements, guidance and/or regulations related to GCP and lead the impact analysis to determine if changes in process & quality documents across CRQA and AGT are required.

  • Responsible for quality oversight to support development programs and submissions by establishing strong collaborative relationships with internal CRQA key stakeholders and AGT functions, as well as of relevant external stakeholders

  • Responsibilities may include:

  • Managing, directing and/or providing leadership to CQA staff. As applicable, responsibilities could include for the development, mentoring and support of direct reports and/or appropriate CQA resources. Could be responsible and accountable for the CQA staff recruitment, development and performance management and organizing CQA teams for maximum effectiveness

  • Managing the assigned budget for the CQA group as part of the overall CRQA budget.

  • Driving trending and metrics across studies and AGT business processes, reporting to AGT management as applicable.

Quantitative Dimensions

  • May support/manage up to 3 CQA resources and/or directly manage 1-5 process improvement/operational excellence initiatives

  • May be responsible for a budget up to $500K

  • Annual auditing globally

  • Responsible for the development and execution of inspection readiness plans for regulatory agency inspections related to MAA / NDA submissions

  • Responsible for supporting regulatory agency inspections of GCP activities and ensuring inspection readiness

Organizational Context

  • Reports to the Executive Director/Senior Director/Director, CQA

  • Peers to this position include CRQA Team Leads, AGT cross-functional department leads, Astellas CRQA Leads, and other functions such as Finance, Legal, Internal Audits, Ethics & Compliance, etc.

  • Supports/Manages up to 3 direct reports and/or outsourced support staff excluding administrative assistants

  • Collaborates directly with AGT personnel

About you

Must Have/Required

  • Bachelor's degree

  • Minimum of 8 years working within a regulated environment such as Regulatory, Quality, Pharmacovigilance or Clinical Development or Operations

  • Expert knowledge of the pharmaceutical and/or CRO industry, pharmaceutical R&D processes and global regulatory agencies, regulations and procedures

  • Proven experience with GCP Quality Management Systems and quality support and oversight of global clinical trials and drug development operations

  • Minimum of 2 years of significant experience in clinical quality assurance

  • Minimum of 2 years people/project management experience, preferably in a highly matrixed, multicultural global setting, requiring facilitation, negotiation, problem-solving, and conflict resolution skills

  • In-depth understanding of GCP requirements for both marketed and investigational products

  • Extensive practical experience and understanding of clinical quality assurance as applied throughout the entire pharmaceutical compound/product life cycle

  • Proficiency in Microsoft Office.

Skills and competencies:

  • Effective interpersonal skills and multi-cultural /intercultural awareness; able to negotiate and build consensus for plans and priorities and able to develop effective relationships through collaboration. Demonstrated competence to build strong working relationships with colleagues and stakeholders

  • Effective oral and written communication and presentation skills in English.

  • Demonstrated ability to proactively predict and resolve complex problems, think strategically and tactically, generate solutions to complex problems and build consensus across the global organization. Able to generate insights and leverage learnings at the individual, team and functional level

  • Domestic and international travel at 10-25% as required.

  • Models our Core Values: Be Bold: Find a Way, Care Deeply, Get Stuff Done -- is experienced as someone who exemplifies the culture we want to create; operates with transparency; is trusted

May Have/Preferred

  • Advanced degree

  • Experience in a startup environment

  • Rare/orphan disease experience

  • Advanced degree in related disciplines

  • This position is located in --San Francisco, CA, United States or remotely.

#LI-LK

Category Clinical and Research Quality Assurance (CRQA)

Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans

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