Sr Director, R&D Quality
Scorpion Therapeutics, California, MO, United States
Role Summary
Senior Director, Inflammation TA Lead, R&D Program Quality, Foster City, CA. Drives the strategy for a global team providing GCP quality oversight for Inflammation products in the Gilead Development portfolio. Partners with R&D functions to apply deep GCP expertise and a proactive, risk-based mindset that accelerates confident decision-making. A key contributor to the R&D Quality Extended Leadership Team, championing a strong culture of Quality across development to deliver better outcomes for patients.
Responsibilities
Design and implement the Quality Strategy for the Inflammation TA.
Lead and direct Quality assessments across the Inflammation portfolio, conducting evaluations that identify risks, assess overall quality health, and guide prioritization of mitigation and improvement efforts.
Lead the analysis and interpretation of Quality data for presentation and reporting to functional and executive leadership.
Lead and supervise the management of critical and/or complex quality events as well as the assessment of serious breaches for the Inflammation TA.
Ensure the development of robust, comprehensive action plans that proactively address Quality and compliance risks.
Lead Quality activities to support product submissions and responses to Health Authorities.
Establish strong partnerships with Clinical Development, Clinical Operations, Regulatory Operations, Safety and Clinical Data Sciences.
Generate clear and actionable insights that strengthen the Audit and Inspection Management programs, ensuring oversight activities are focused where they matter most.
Drive implementation of Quality by Design principles in Inflammation development programs.
Collaborate with Virology and Oncology TA Leads aligning cross-TA risks and the staff resourcing strategy.
Drive risk-based decision making by delivering clear, insightful rationale that reflect sound judgement and deep Quality expertise.
Participate in licensing and collaboration activities as applicable.
Support management of internal inspection preparation activities and overall readiness throughout program life cycle for Gilead study teams.
Identify and drive continuous quality process improvements through assessment of audit, inspection and quality event outcomes and identification of trends from internal deviations.
Provide guidance and training on relevant GxP regulations and guidelines to cross-functional business partners.
Serve as an expert and provide guidance on and interpretation of global GCP regulations and Gilead standards for internal stakeholders.
Interface with external Quality organizations for Gilead development partners and collaborations.
Support overall R&D Quality goals and objectives including but not limited to resource budget and outputs, and line management oversight of the team.
Supervise, develop, train and manage internal staff; foster a commitment to quality and a culture of quality within the organization.
Lead intra- or interdepartmental teams such as continuous improvement initiatives.
Qualifications
Broad GCP audit and compliance experience; Clinical Quality Assurance/Compliance experience in a bio-pharma sponsor organization.
Experience implementing Quality Risk Management (ICH Q9) and ICH E6 R3 principles.
Track record of experience in managing therapeutic area and/or disease-specific compliance programs.
Must have strong verbal, written, interpersonal skills and the ability to present to executives.
Recognized as an expert resource on a range of compliance topics.
Management of junior and senior staff; ability to lead cross-functional teams.
Proficient in Microsoft Office suite.
Experience with Inspection and CAPA management programs (strongly preferred).
Familiarity with GVP and 21 CFR Part 11 electronic systems and compliance activities (preferred).
Excellent organizational and project management skills.
Education
Bachelor’s degree with 12+ years; Master’s degree with 10+ years; or PhD with 8+ years of R&D quality/compliance experience.
Skills
GCP/GxP regulatory knowledge and quality management systems.
Audit and inspection management; CAPA processes.
Quality by Design (QbD) principles.
Cross-functional collaboration and stakeholder management.
Data analysis, interpretation, and reporting to leadership.
Leadership, mentoring, and people management.
Microsoft Office proficiency.
Additional Requirements
Ability to travel approximately 20%.
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Responsibilities
Design and implement the Quality Strategy for the Inflammation TA.
Lead and direct Quality assessments across the Inflammation portfolio, conducting evaluations that identify risks, assess overall quality health, and guide prioritization of mitigation and improvement efforts.
Lead the analysis and interpretation of Quality data for presentation and reporting to functional and executive leadership.
Lead and supervise the management of critical and/or complex quality events as well as the assessment of serious breaches for the Inflammation TA.
Ensure the development of robust, comprehensive action plans that proactively address Quality and compliance risks.
Lead Quality activities to support product submissions and responses to Health Authorities.
Establish strong partnerships with Clinical Development, Clinical Operations, Regulatory Operations, Safety and Clinical Data Sciences.
Generate clear and actionable insights that strengthen the Audit and Inspection Management programs, ensuring oversight activities are focused where they matter most.
Drive implementation of Quality by Design principles in Inflammation development programs.
Collaborate with Virology and Oncology TA Leads aligning cross-TA risks and the staff resourcing strategy.
Drive risk-based decision making by delivering clear, insightful rationale that reflect sound judgement and deep Quality expertise.
Participate in licensing and collaboration activities as applicable.
Support management of internal inspection preparation activities and overall readiness throughout program life cycle for Gilead study teams.
Identify and drive continuous quality process improvements through assessment of audit, inspection and quality event outcomes and identification of trends from internal deviations.
Provide guidance and training on relevant GxP regulations and guidelines to cross-functional business partners.
Serve as an expert and provide guidance on and interpretation of global GCP regulations and Gilead standards for internal stakeholders.
Interface with external Quality organizations for Gilead development partners and collaborations.
Support overall R&D Quality goals and objectives including but not limited to resource budget and outputs, and line management oversight of the team.
Supervise, develop, train and manage internal staff; foster a commitment to quality and a culture of quality within the organization.
Lead intra- or interdepartmental teams such as continuous improvement initiatives.
Qualifications
Broad GCP audit and compliance experience; Clinical Quality Assurance/Compliance experience in a bio-pharma sponsor organization.
Experience implementing Quality Risk Management (ICH Q9) and ICH E6 R3 principles.
Track record of experience in managing therapeutic area and/or disease-specific compliance programs.
Must have strong verbal, written, interpersonal skills and the ability to present to executives.
Recognized as an expert resource on a range of compliance topics.
Management of junior and senior staff; ability to lead cross-functional teams.
Proficient in Microsoft Office suite.
Experience with Inspection and CAPA management programs (strongly preferred).
Familiarity with GVP and 21 CFR Part 11 electronic systems and compliance activities (preferred).
Excellent organizational and project management skills.
Education
Bachelor’s degree with 12+ years; Master’s degree with 10+ years; or PhD with 8+ years of R&D quality/compliance experience.
Skills
GCP/GxP regulatory knowledge and quality management systems.
Audit and inspection management; CAPA processes.
Quality by Design (QbD) principles.
Cross-functional collaboration and stakeholder management.
Data analysis, interpretation, and reporting to leadership.
Leadership, mentoring, and people management.
Microsoft Office proficiency.
Additional Requirements
Ability to travel approximately 20%.
#J-18808-Ljbffr