Executive Director, Risk and Proactive Quality
Gilead Sciences
5 hours ago
Remote friendly (Parsippany, NJ)
United States
Operations
Key Accountabilities
- Serve as Global Business Process Owner (BPO) for Quality Risk Management, with enterprise accountability for strategy, standards, performance, and continuous improvement.
- Provide executive leadership and oversight for global process owners: Change Control; Medical Device and Combination Product Risk; Proactive Human and Organizational Performance (HOP).
- Design, own, and approve global standards, policies, and procedures aligned with cGMP, ICH, and regulatory expectations.
- Integrate and align risk, change, device/combination product, and human performance processes across the Pharmaceutical Quality System (PQS).
- Define and execute the global Proactive Quality and Risk Management strategy to enable early risk identification, mitigation, and prevention across operations and the supply chain.
- Drive evolution of organizational risk maturity, capability, and culture; embed risk-based thinking into decision-making.
- Oversee the enterprise Quality Risk Register and develop the Operations Quality risk profile for leadership review.
- Provide strategic leadership for the Proactive HOP global process; champion learning-based, non-punitive approaches to strengthen human performance and system reliability.
- Provide executive governance of the global Change Control process to ensure risk-assessed, compliant implementation.
- Oversee Medical Device and Combination Product Risk Management across development, manufacturing, and post-market activities.
- Ensure cross-functional collaboration (Technical, Regulatory, Safety, Operations) to manage complex product and process risks.
- Lead and develop a global network of BPOs, subject matter experts, and process leaders; represent Quality in governance, inspections, and regulatory interactions.
- Monitor audit/inspection outcomes, deviations, complaints, and emerging regulatory trends; sponsor transformational initiatives using Lean principles, digital enablement, and innovation.
Typical People Management Responsibility
- Senior leader of multiple global process owners and expert teams.
- Direct and indirect management of global, cross-functional teams.
- Matrix leadership across sites, regions, and functions.
Essential
- BS/BA with 16+ years, or MS/MA/PhD with 14+ years in pharmaceutical quality, manufacturing, or related scientific discipline.
- Deep expertise in Quality Risk Management; demonstrated success implementing global risk programs.
- Extensive experience across multiple areas of Quality in a regulated pharmaceutical environment.
- Proven ability to lead through influence in complex, matrixed, multinational organizations.
- Strong strategic thinking, communication, and stakeholder engagement.
Desirable
- Experience leading large-scale Quality or Operations transformation initiatives.
- Experience with Human and Organizational Performance (HOP) and Proactive Human Dependent Process Improvement.
- Expertise in Business Process Management, Lean, Six Sigma, or comparable continuous improvement.
- Experience overseeing GxP IT systems and digital enablement of Quality processes.
- Strong business acumen; ability to analyze trends, assess risk, and build business cases.
Benefits (explicitly mentioned)
- Eligible for discretionary annual bonus and discretionary stock-based long-term incentives (eligibility varies), paid time off, and company-sponsored medical, dental, vision, and life insurance.
Application Instructions
- Please apply via the Internal Career Opportunities portal in Workday.
- Serve as Global Business Process Owner (BPO) for Quality Risk Management, with enterprise accountability for strategy, standards, performance, and continuous improvement.
- Provide executive leadership and oversight for global process owners: Change Control; Medical Device and Combination Product Risk; Proactive Human and Organizational Performance (HOP).
- Design, own, and approve global standards, policies, and procedures aligned with cGMP, ICH, and regulatory expectations.
- Integrate and align risk, change, device/combination product, and human performance processes across the Pharmaceutical Quality System (PQS).
- Define and execute the global Proactive Quality and Risk Management strategy to enable early risk identification, mitigation, and prevention across operations and the supply chain.
- Drive evolution of organizational risk maturity, capability, and culture; embed risk-based thinking into decision-making.
- Oversee the enterprise Quality Risk Register and develop the Operations Quality risk profile for leadership review.
- Provide strategic leadership for the Proactive HOP global process; champion learning-based, non-punitive approaches to strengthen human performance and system reliability.
- Provide executive governance of the global Change Control process to ensure risk-assessed, compliant implementation.
- Oversee Medical Device and Combination Product Risk Management across development, manufacturing, and post-market activities.
- Ensure cross-functional collaboration (Technical, Regulatory, Safety, Operations) to manage complex product and process risks.
- Lead and develop a global network of BPOs, subject matter experts, and process leaders; represent Quality in governance, inspections, and regulatory interactions.
- Monitor audit/inspection outcomes, deviations, complaints, and emerging regulatory trends; sponsor transformational initiatives using Lean principles, digital enablement, and innovation.
Typical People Management Responsibility
- Senior leader of multiple global process owners and expert teams.
- Direct and indirect management of global, cross-functional teams.
- Matrix leadership across sites, regions, and functions.
Essential
- BS/BA with 16+ years, or MS/MA/PhD with 14+ years in pharmaceutical quality, manufacturing, or related scientific discipline.
- Deep expertise in Quality Risk Management; demonstrated success implementing global risk programs.
- Extensive experience across multiple areas of Quality in a regulated pharmaceutical environment.
- Proven ability to lead through influence in complex, matrixed, multinational organizations.
- Strong strategic thinking, communication, and stakeholder engagement.
Desirable
- Experience leading large-scale Quality or Operations transformation initiatives.
- Experience with Human and Organizational Performance (HOP) and Proactive Human Dependent Process Improvement.
- Expertise in Business Process Management, Lean, Six Sigma, or comparable continuous improvement.
- Experience overseeing GxP IT systems and digital enablement of Quality processes.
- Strong business acumen; ability to analyze trends, assess risk, and build business cases.
Benefits (explicitly mentioned)
- Eligible for discretionary annual bonus and discretionary stock-based long-term incentives (eligibility varies), paid time off, and company-sponsored medical, dental, vision, and life insurance.
Application Instructions
- Please apply via the Internal Career Opportunities portal in Workday.