Senior Director, Internal Manufacturing Quality

This is a fully remote position, open to applicants in United States.

📋 Description

• Lead the global strategy, governance, and performance management of regional manufacturing quality programs.

• Ensure that internal sites comply with regulatory, quality, and business standards for a seamless supply of GMP/GDP materials, components, intermediates, and finished products.

• Shape and drive the quality strategy, enhance quality systems and regulatory compliance, and collaborate with manufacturing, supply chain, R&D, and leadership teams.

• Define and implement a comprehensive internal manufacturing quality strategy that aligns with company objectives and regulatory standards.

• Establish standardized internal quality frameworks, policies, and KPIs across various regions.

• Promote global consistency in quality practices while accommodating local regulatory nuances.

• Act as the primary escalation point for quality issues within global internal manufacturing.

• Lead and mentor Regional Directors for the Americas, EMA, and APAC, as well as heads of internal quality business units.

• Oversee the tracking, monitoring, and communication of internal manufacturing risks.

• Influence functional organizations to tackle systemic quality issues, mitigate risks, and enhance inspection readiness.

• Ensure risk-based qualification in accordance with ICH Q9, ICH Q10, and relevant GMP requirements.

• Conduct regular business reviews and performance evaluations.

• Drive improvements in product quality and monitor regional quality metrics and dashboards.

• Lead cross-regional root cause analysis and CAPA programs.

• Build a high-performing global quality organization and plan for succession for regional and site-level quality leaders.

• Oversee response and escalation protocols for deviations, OOS, critical defects, and supply-related disruptions.

• Serve as a critical decision-maker in cross-functional crisis management.

• Collaborate with Procurement, Operations, Technical, Manufacturing Operations, Supply Chain, Development, Regulatory, and Global Quality teams.

• Create and implement a Quality Transformation plan along with manufacturing quality initiatives.

• Scale best practices across sites and regions while incorporating digital tools.

• Lead cross-functional teams focused on quality improvement initiatives.

⛳️ Requirements

• Strong commitment to excellence.

• Results-driven mindset with an emphasis on measurable outcomes.

• Innovative and creative thinking.

• Excellent communication skills.

• Strong collaboration abilities.

• Resilience in challenging situations.

• An inclusive mindset.

• Adaptability in a fast-paced environment.

• Ethical behavior and integrity.

• Dedication to continuous learning and professional growth.

• Familiarity with regulatory, quality, and business requirements for GMP/GDP materials, components, intermediates, and finished products.

• Understanding of ICH Q9, ICH Q10, and applicable GMP standards.

🏝️ Benefits

• Competitive salaries.

• Annual performance-based bonuses.

• Equity-based incentive program.

• Generous vacation policy.

• Paid wellness days.

• Support for learning and development opportunities.

• Fully remote work arrangement.

• Approximately 30% travel, including international travel.