Senior Director, Quality Assurance - Distribution
Scorpion Therapeutics, San Francisco, California, United States, 94199
Role Summary
The Senior Director, Quality Assurance - Distribution is accountable for QA operations in US, Canada and LATAM to ensure GMP and GDP compliance for Gilead products. The role develops QA strategies to strengthen and harmonize GDP compliance across the regions and sits on the GPD&A leadership team, contributing to strategy, governance, and operational development of Quality Distribution and QA Operations across markets. Responsibilities
Serve as a key member of the GPD&A Leadership Team, implementing cohesive and effective QA processes across the distribution network and developing medium- and long-term strategic plans for all regions to support the overall quality organization. Coach and mentor direct reports to drive independence, development, and performance, and provide leadership to ensure a safe, respectful, and inclusive work environment. Manage financial budget, resources, and workload to ensure local QA activities meet timelines and quality/compliance expectations; monitor KPIs and project milestones and provide prioritization guidance as needed. Act as Senior QA advisor to in-country and cluster QA leads with interpreting local and regional regulatory requirements for distribution of Gilead products. Act as senior liaison with distribution partners in US, Canada & LATAM regarding escalations, major issues, and changes affecting business models with these partners. Interface with regulatory agencies as required, representing Gilead to authorities and regulatory inspectorates. Provide leadership for local market activities supporting product recalls and readiness for recall or other market actions. Lead highly complex investigations and develop/implement CAPA as required. Partner with QA colleagues to develop strategies supporting in-country QA operations, including standards, processes, and procedures. Collaborate cross-functionally with quality groups, Regulatory Affairs, Global Trade Ops, Global Commercial Operations, Legal, and external distribution partners to establish strong working relationships. Act as an internal escalation contact for complex and high-impact quality issues and decisions. Lead cross-functional regional/global projects and process improvement initiatives with significant business impact. Act as deputy for the Executive Director as required, supporting complex and high-impact quality-related issues and escalations. Qualifications
14+ years of relevant experience with a bachelor’s degree in science or related field, or 12+ years with an advanced science degree (MS, MD, PharmD, PhD) or an MBA; or 20+ years in pharmaceutical warehouse and distribution. Comprehensive knowledge and experience in quality assurance within highly regulated distribution environments. Prior people management experience. Broad experience across customer service, warehouse operations, logistics and transport; understanding of Oral Solid Dosage, Parenteral and Aseptic operations is beneficial. Skills
Deep understanding and application of GDP principles across US, Canada, LATAM and awareness in other regions. Ability to develop complex concepts, techniques, standards, and new applications based on quality principles. Anticipates shifts in industry trends and regulatory environments to position the function to respond. Strong knowledge of aseptic processing, solid dose and general pharmaceutical manufacturing. Ability to develop innovative solutions to complex problems where precedents may not exist. Extensive knowledge of industry best practices and trends; excellent verbal, written, and interpersonal communication and influencing skills. Comfort interacting with regulatory agencies and representing Gilead in public forums. Ability to identify, understand, and exceed customer expectations; experience in managing staff. Experience initiating and supporting change and driving continuous improvement aligned with organizational strategy. Education
Bachelor’s degree in science or related field required for 14+ years of experience; advanced degree (MS, MD, PharmD, PhD) or MBA permitted for 12+ years of experience.
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The Senior Director, Quality Assurance - Distribution is accountable for QA operations in US, Canada and LATAM to ensure GMP and GDP compliance for Gilead products. The role develops QA strategies to strengthen and harmonize GDP compliance across the regions and sits on the GPD&A leadership team, contributing to strategy, governance, and operational development of Quality Distribution and QA Operations across markets. Responsibilities
Serve as a key member of the GPD&A Leadership Team, implementing cohesive and effective QA processes across the distribution network and developing medium- and long-term strategic plans for all regions to support the overall quality organization. Coach and mentor direct reports to drive independence, development, and performance, and provide leadership to ensure a safe, respectful, and inclusive work environment. Manage financial budget, resources, and workload to ensure local QA activities meet timelines and quality/compliance expectations; monitor KPIs and project milestones and provide prioritization guidance as needed. Act as Senior QA advisor to in-country and cluster QA leads with interpreting local and regional regulatory requirements for distribution of Gilead products. Act as senior liaison with distribution partners in US, Canada & LATAM regarding escalations, major issues, and changes affecting business models with these partners. Interface with regulatory agencies as required, representing Gilead to authorities and regulatory inspectorates. Provide leadership for local market activities supporting product recalls and readiness for recall or other market actions. Lead highly complex investigations and develop/implement CAPA as required. Partner with QA colleagues to develop strategies supporting in-country QA operations, including standards, processes, and procedures. Collaborate cross-functionally with quality groups, Regulatory Affairs, Global Trade Ops, Global Commercial Operations, Legal, and external distribution partners to establish strong working relationships. Act as an internal escalation contact for complex and high-impact quality issues and decisions. Lead cross-functional regional/global projects and process improvement initiatives with significant business impact. Act as deputy for the Executive Director as required, supporting complex and high-impact quality-related issues and escalations. Qualifications
14+ years of relevant experience with a bachelor’s degree in science or related field, or 12+ years with an advanced science degree (MS, MD, PharmD, PhD) or an MBA; or 20+ years in pharmaceutical warehouse and distribution. Comprehensive knowledge and experience in quality assurance within highly regulated distribution environments. Prior people management experience. Broad experience across customer service, warehouse operations, logistics and transport; understanding of Oral Solid Dosage, Parenteral and Aseptic operations is beneficial. Skills
Deep understanding and application of GDP principles across US, Canada, LATAM and awareness in other regions. Ability to develop complex concepts, techniques, standards, and new applications based on quality principles. Anticipates shifts in industry trends and regulatory environments to position the function to respond. Strong knowledge of aseptic processing, solid dose and general pharmaceutical manufacturing. Ability to develop innovative solutions to complex problems where precedents may not exist. Extensive knowledge of industry best practices and trends; excellent verbal, written, and interpersonal communication and influencing skills. Comfort interacting with regulatory agencies and representing Gilead in public forums. Ability to identify, understand, and exceed customer expectations; experience in managing staff. Experience initiating and supporting change and driving continuous improvement aligned with organizational strategy. Education
Bachelor’s degree in science or related field required for 14+ years of experience; advanced degree (MS, MD, PharmD, PhD) or MBA permitted for 12+ years of experience.
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