Sr Director, Proactive Quality Human & Organizational Performance (HOP)
Gilead Sciences
8 hours ago
Remote friendly (San Francisco Bay Area)
United States
Human Resources
Senior Director, Proactive Human & Organizational Performance (HOP)
Key Accountabilities
- Serve as Global Business Process Owner (BPO) for Proactive HOP; accountable for strategy, standards, performance, and continuous improvement.
- Design, own, and approve global standards, policies, procedures, and training/job aids aligned with cGMP, ICH, and regulatory expectations.
- Define global KPIs; monitor adherence and effectiveness; drive global standardization, simplification, and sustained adoption.
- Provide SME coaching/consultation to sites/regions on human-centric risk mitigation and human-dependent process design.
- Monitor process performance signals (audit/inspection observations, issue management, deviations, complaints, trend data) and escalate/correct systemic risks.
- Own inspection readiness and defense for Proactive HOP, including observation responses and sustained remediation.
- Manage interdependencies with other PQS processes/GPOs (risk management, deviations, change control, training, self-inspection) for end-to-end integration.
- Partner with IT system owners to maintain business requirements; ensure Quality IT solutions meet GxP requirements and approve relevant changes/releases.
Integration and Delivery
- Implement proactive improvements to human-dependent processes (e.g., risk management, deviations, change control, self-inspection, training).
- Co-develop proactive operations objectives; support sites with locally relevant deliverables aligned to global priorities.
- Establish governance to track deliverables, benefits realization, and sustainability.
- Lead/sponsor continuous improvement initiatives (HDPI acceleration, proactive risk assessment, error-proofing, digital enablement).
HOP/Systems-Model / HDPI Acceleration
- Build regional capability to apply HOP/HDPI and systems-model thinking to prevent impactful errors.
- Mentor/coach teams to modernize control strategies (focus on true critical steps and error-likely conditions).
- Embed Proactive HOP into equipment and process design with engineering/technical/operational partners.
- Provide remote and in-person support (workshops, Gemba, coaching) to accelerate adoption.
Tools/Training/Community of Practice
- Develop/maintain global training curricula, certification requirements, and job aids.
- Deliver/oversee train-the-trainer models to scale via champions.
- Facilitate sharing and adoption of good practices/lessons learned.
- Seek user feedback to simplify, automate, and error-proof to reduce manual burden.
Leadership/Influence/External Engagement
- Lead through influence in a matrixed environment to deliver sustained proactive quality outcomes.
- Monitor external trends and translate into updates to strategy, standards, and capability building.
- Represent the organization in external industry forums related to HOP and proactive quality.
Typical People Management Responsibility
- Senior leader of a global Proactive HOP process network with matrix accountability across sites/functions.
- May include direct management of a small expert team and/or program resources (TBD), with broader influence-based leadership across the network.
Global Remit
- Enterprise-wide accountability across global markets/regions.
- Travel approximately 25–35%.
Essential Qualifications/Skills/Experience
- Bachelor’s degree and/or substantial relevant experience; 14+ years in pharmaceutical quality, manufacturing, engineering, or related scientific discipline.
- Cross-function and cross-cultural experience in a regulated supply chain environment.
- Ability to influence and define global ways of working in complex, matrixed organizations.
- Strong risk-based decision-making and systems mindset; translate insights into practical controls/behaviors.
- Excellent communication skills and ability to build relationships globally with cross-functional customers.
- Independence with minimal supervision; strong planning, prioritization, and follow-through.
- Subject matter expertise in HOP and HDPI and their proactive application.
Desirable Qualifications/Skills/Experience
- Experience leading transformational change and capability-building at scale.
- GMP change control and event/deviation management experience.
- Business Process Management and operating model design; change agent roles.
- Project/program management including governance, planning, and benefits realization.
- Experience with global GxP IT systems delivery/lifecycle management and digital enablement of quality processes.
- Business acumen; ability to assess complex data and build business cases/impact analyses.
- Training/certification in Lean, Six Sigma, or comparable continuous improvement methodologies.
- Experience with DAI or similar structured decision-making approaches.
Benefits (as stated)
- Salary range: $243,100.00 - $314,600.00.
- May be eligible for discretionary annual bonus and discretionary stock-based long-term incentives; paid time off; benefits package including company-sponsored medical, dental, vision, and life insurance plans.
Application Instructions
- Apply via the Internal Career Opportunities portal in Workday.
Key Accountabilities
- Serve as Global Business Process Owner (BPO) for Proactive HOP; accountable for strategy, standards, performance, and continuous improvement.
- Design, own, and approve global standards, policies, procedures, and training/job aids aligned with cGMP, ICH, and regulatory expectations.
- Define global KPIs; monitor adherence and effectiveness; drive global standardization, simplification, and sustained adoption.
- Provide SME coaching/consultation to sites/regions on human-centric risk mitigation and human-dependent process design.
- Monitor process performance signals (audit/inspection observations, issue management, deviations, complaints, trend data) and escalate/correct systemic risks.
- Own inspection readiness and defense for Proactive HOP, including observation responses and sustained remediation.
- Manage interdependencies with other PQS processes/GPOs (risk management, deviations, change control, training, self-inspection) for end-to-end integration.
- Partner with IT system owners to maintain business requirements; ensure Quality IT solutions meet GxP requirements and approve relevant changes/releases.
Integration and Delivery
- Implement proactive improvements to human-dependent processes (e.g., risk management, deviations, change control, self-inspection, training).
- Co-develop proactive operations objectives; support sites with locally relevant deliverables aligned to global priorities.
- Establish governance to track deliverables, benefits realization, and sustainability.
- Lead/sponsor continuous improvement initiatives (HDPI acceleration, proactive risk assessment, error-proofing, digital enablement).
HOP/Systems-Model / HDPI Acceleration
- Build regional capability to apply HOP/HDPI and systems-model thinking to prevent impactful errors.
- Mentor/coach teams to modernize control strategies (focus on true critical steps and error-likely conditions).
- Embed Proactive HOP into equipment and process design with engineering/technical/operational partners.
- Provide remote and in-person support (workshops, Gemba, coaching) to accelerate adoption.
Tools/Training/Community of Practice
- Develop/maintain global training curricula, certification requirements, and job aids.
- Deliver/oversee train-the-trainer models to scale via champions.
- Facilitate sharing and adoption of good practices/lessons learned.
- Seek user feedback to simplify, automate, and error-proof to reduce manual burden.
Leadership/Influence/External Engagement
- Lead through influence in a matrixed environment to deliver sustained proactive quality outcomes.
- Monitor external trends and translate into updates to strategy, standards, and capability building.
- Represent the organization in external industry forums related to HOP and proactive quality.
Typical People Management Responsibility
- Senior leader of a global Proactive HOP process network with matrix accountability across sites/functions.
- May include direct management of a small expert team and/or program resources (TBD), with broader influence-based leadership across the network.
Global Remit
- Enterprise-wide accountability across global markets/regions.
- Travel approximately 25–35%.
Essential Qualifications/Skills/Experience
- Bachelor’s degree and/or substantial relevant experience; 14+ years in pharmaceutical quality, manufacturing, engineering, or related scientific discipline.
- Cross-function and cross-cultural experience in a regulated supply chain environment.
- Ability to influence and define global ways of working in complex, matrixed organizations.
- Strong risk-based decision-making and systems mindset; translate insights into practical controls/behaviors.
- Excellent communication skills and ability to build relationships globally with cross-functional customers.
- Independence with minimal supervision; strong planning, prioritization, and follow-through.
- Subject matter expertise in HOP and HDPI and their proactive application.
Desirable Qualifications/Skills/Experience
- Experience leading transformational change and capability-building at scale.
- GMP change control and event/deviation management experience.
- Business Process Management and operating model design; change agent roles.
- Project/program management including governance, planning, and benefits realization.
- Experience with global GxP IT systems delivery/lifecycle management and digital enablement of quality processes.
- Business acumen; ability to assess complex data and build business cases/impact analyses.
- Training/certification in Lean, Six Sigma, or comparable continuous improvement methodologies.
- Experience with DAI or similar structured decision-making approaches.
Benefits (as stated)
- Salary range: $243,100.00 - $314,600.00.
- May be eligible for discretionary annual bonus and discretionary stock-based long-term incentives; paid time off; benefits package including company-sponsored medical, dental, vision, and life insurance plans.
Application Instructions
- Apply via the Internal Career Opportunities portal in Workday.