Seagen
Head, Oncology Quality
Seagen, Bothell, Washington, United States, 98021
ROLE SUMMARY:The Head, Oncology Quality will report to the Head of Clinical Development and Operations. This position's primary responsibility is to provide leadership and oversight of a team of Global R&D Quality Assurance Professionals in support of multiple early and late phase development programs and is the strategic and operational leader for this group.
This position manages and directs the ongoing Compliance and Quality Assurance activities to support GLP, GCP, GCLP, and other GxP work in ongoing and planned clinical trials, as well as clinical and non-clinical development laboratory activities.
This role requires the proven ability to coach and mentor staff to ensure a high level of quality in our clinical and non-clinical trials and to interact with regulatory authorities to enable successful regulatory inspection outcomes, strong collaboration with internal and external development partners, and effective communication with company leadership.
This position serves as a subject matter expert to team members for the regulatory requirements, processes, and logistics to conduct global drug development activities for compounds from the preclinical stage through the initial marketing application, and ultimately life cycle management.
The Head, Oncology Quality provides inspirational leadership to a team of experienced clinical development and regulatory professionals and balances their role as a champion for their team with company-wide needs.ROLE RESPONSIBILITIES:Global design and strategy, development, deployment, and continuous improvement of RDQ systems and functions, with supporting the entire Pfizer oncology portfolio across all Pfizer Oncology R&D teams.Directly interact with applicable Development, GPS, Px and Corporate Legal departments to assess risk and assure that effective RDQ auditing functions are in place and executed to address company requirements for vendor/subcontractor qualification audits (clinical and nonclinical), global clinical investigator site audits, clinical immunology laboratory audits (internal and external), nonclinical data, internal and external databases (e.g. clinical studies and safety databases), and key deliverables/study components (e.g. study process documents, TMFs, CSRs, tables, listings, ISS, ISE).Educates and drives a quality risk management culture and manages/escalates the company's compliance risks and visibility to Senior Leadership, including creation, tracking, and assisting in presenting metrics on the health of Development wide programs and systems on a frequent basis to senior internal and external stakeholders.Review and approval of development reports, qualification reports, validation protocols, reports, and amendments, nonclinical protocols and reports, CAPA, and deviations.Administration and oversight for internal and clinical site training, clinical and nonclinical investigations, databases for the quality system, annual reports and quality trending reports, and evaluation of quality events, incidents, and complaints.Provides mentorship, leadership, and prioritization to staff to execute their respective duties.Stays current with related quality legislation, compliance issues, and is an internal Pfizer subject matter expert for changes in GxP expectations, including FDA, EU and other relevant foreign regulatory bodies, guidance documents and best industry practices.Effectively cooperates and communicates with departments across the company to analyze and resolve quality and technical issues and mitigate identified risks in accordance with appropriate company standards.Supports regulatory inspections as necessary including training applicable Development staff and leading the preparation, conduct, and responses to regulatory agencies.Work effectively with the PRD CD&O Quality CoE to ensure cross-Pfizer alignment on quality topics.Budget responsibility for Oncology Quality Unit budget.QUALIFICATIONS:BS/MS in a related science field; advanced degree desirable.20+ years' experience in Clinical Quality Assurance or related field, consisting of 5+ years supervisory experience.Comprehensive knowledge of drug development process, drug laws, regulations and guidelines.Ability to work independently and within a group setting and to interact effectively with different functional departments.Strong communication skills (oral, written, and interpersonal) and the ability to identify and recommend solutions to problems.Ability to establish and build collaborative relationships with senior and executive management, staff, colleagues, and regulatory authorities.Demonstrates flexibility in dealing with change and diversity.Possesses strong critical and logical thinking.
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This position manages and directs the ongoing Compliance and Quality Assurance activities to support GLP, GCP, GCLP, and other GxP work in ongoing and planned clinical trials, as well as clinical and non-clinical development laboratory activities.
This role requires the proven ability to coach and mentor staff to ensure a high level of quality in our clinical and non-clinical trials and to interact with regulatory authorities to enable successful regulatory inspection outcomes, strong collaboration with internal and external development partners, and effective communication with company leadership.
This position serves as a subject matter expert to team members for the regulatory requirements, processes, and logistics to conduct global drug development activities for compounds from the preclinical stage through the initial marketing application, and ultimately life cycle management.
The Head, Oncology Quality provides inspirational leadership to a team of experienced clinical development and regulatory professionals and balances their role as a champion for their team with company-wide needs.ROLE RESPONSIBILITIES:Global design and strategy, development, deployment, and continuous improvement of RDQ systems and functions, with supporting the entire Pfizer oncology portfolio across all Pfizer Oncology R&D teams.Directly interact with applicable Development, GPS, Px and Corporate Legal departments to assess risk and assure that effective RDQ auditing functions are in place and executed to address company requirements for vendor/subcontractor qualification audits (clinical and nonclinical), global clinical investigator site audits, clinical immunology laboratory audits (internal and external), nonclinical data, internal and external databases (e.g. clinical studies and safety databases), and key deliverables/study components (e.g. study process documents, TMFs, CSRs, tables, listings, ISS, ISE).Educates and drives a quality risk management culture and manages/escalates the company's compliance risks and visibility to Senior Leadership, including creation, tracking, and assisting in presenting metrics on the health of Development wide programs and systems on a frequent basis to senior internal and external stakeholders.Review and approval of development reports, qualification reports, validation protocols, reports, and amendments, nonclinical protocols and reports, CAPA, and deviations.Administration and oversight for internal and clinical site training, clinical and nonclinical investigations, databases for the quality system, annual reports and quality trending reports, and evaluation of quality events, incidents, and complaints.Provides mentorship, leadership, and prioritization to staff to execute their respective duties.Stays current with related quality legislation, compliance issues, and is an internal Pfizer subject matter expert for changes in GxP expectations, including FDA, EU and other relevant foreign regulatory bodies, guidance documents and best industry practices.Effectively cooperates and communicates with departments across the company to analyze and resolve quality and technical issues and mitigate identified risks in accordance with appropriate company standards.Supports regulatory inspections as necessary including training applicable Development staff and leading the preparation, conduct, and responses to regulatory agencies.Work effectively with the PRD CD&O Quality CoE to ensure cross-Pfizer alignment on quality topics.Budget responsibility for Oncology Quality Unit budget.QUALIFICATIONS:BS/MS in a related science field; advanced degree desirable.20+ years' experience in Clinical Quality Assurance or related field, consisting of 5+ years supervisory experience.Comprehensive knowledge of drug development process, drug laws, regulations and guidelines.Ability to work independently and within a group setting and to interact effectively with different functional departments.Strong communication skills (oral, written, and interpersonal) and the ability to identify and recommend solutions to problems.Ability to establish and build collaborative relationships with senior and executive management, staff, colleagues, and regulatory authorities.Demonstrates flexibility in dealing with change and diversity.Possesses strong critical and logical thinking.
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