Purpose of the function

LOCATION: Munich, Germany / Zurich, Switzerland 

The Senior Director is a key member of the Global R&D PV QA Leadership Team, driving execution of the Mid Term Strategy (MTS), strategic transformation initiatives, and operational excellence across the Americas, Europe, and globally. Acts as deputy and strategic advisor to the Head of Global R&D PV QA and Global QA, translating vision into action, embedding collaboration and accountability, and delivering on global priorities.Leads change management, governance, and communication frameworks, while fostering a high-performing, positive working environment. Oversees talent development, including onboarding, coaching, and mentoring, and ensures seamless execution of cross-functional initiatives aligned with global objectives.

Roles and Responsibilities

• Strategic Planning and Execution
• Lead the development, deployment, and monitoring of the Mid Term Strategy for Global R&D PV QA, ensuring alignment with global objectives and operational excellence.
• Shape and drive end‑to‑end execution of the MTS across Americas/Europe with global remit, ensuring integration of talent strategy, governance enhancement, QMS improvements, inspection readiness, and enterprise risk mitigation.
• Serve as a senior advisor and integrator, translating strategic priorities into actionable plans and measurable outcomes across regional and global teams.
• Act as a strategic partner and force multiplier to N‑3 leaders across Global R&D and PV QA and Global QA, translating executive vision into structured execution roadmaps with clear accountability and measurable impact.
• Oversee execution of major cross-functional projects and initiatives, ensuring delivery of key milestones and continuous improvement in processes and outcomes.
• Lead high‑visibility, cross‑functional transformation programs (e.g., audit/CAPA, inspection readiness, vendor oversight, eQMS/data integrity) with material impact on regulatory readiness, QMS performance, and enterprise risk exposure.
• Drive the implementation of MTS such as Securing adequate and capable QA Talent, including strategy formulation and project execution for workforce planning, talent acquisition, development, and retention within Global RandD PV QA
• Lead global change management initiatives to support organizational transformation and continuous improvement within Global RandD PV QA.
• Accountable for leadership decision support impacting resource allocation, talent capability, compliance posture, and company‑level quality outcomes.
• Act as the deputy to the Head, Global Strategy and Operations, collaborating closely with the Head Global RandD and PV QA (N‑2) to ensure coordinated execution of MTS across Americas, Europe and the globe. Leadership Team Effectiveness and Stakeholder Engagement
• Orchestrate and facilitate leadership team meetings, offsites, and key forums to maximize effectiveness, focus, and follow-through.
• Serve as a liaison between the Head of Global Strategy and Operations, Head Global R&D PV QA, leadership team, and key stakeholders, ensuring timely and transparent communication and alignment.
• Build trusted relationships and alignment across matrixed, multi‑regional leadership (N‑1/N‑2/N‑3), negotiating priorities with functional heads and facilitating complex cross‑regional governance discussions.
• Develop, implement, and maintain governance and communication rules to enhance collaboration, transparency, and decision-making effectiveness across Global R&D PV QA teams.
• Establish and oversee structured communication and engagement frameworks for Global R&D PV QA members globally, embedding a culture of accountability, collaboration, and quality.
• Drive initiatives to build and sustain a positive and efficient working environment that supports employee engagement and productivity.
• Lead the Global R&D PV QA Glint Survey process in collaboration with HR, ensuring robust action planning and measurable improvement across Global R&D PV QA and Global QA.

Further Roles and Responsibilities

• Represent Global R&D PV QA in cross-functional collaborations and presentations with R&D Unit Heads, CSPV, Medical Affairs, Corporate Planning, Finance, HR, and Risk Management to foster a unified global quality culture.
• Oversee day-to-day business operations, including budget management, resource allocation, and performance tracking, ensuring operational excellence across regional and global structures.
• Lead process simplification, governance, and the establishment of performance metrics to drive efficiency, effectiveness, and measurable impact on QMS performance, regulatory inspection readiness, and compliance risk mitigation.
• Implement change management and onboarding processes to ensure strategic alignment, operational excellence, and continuous improvement at both regional and global levels.
• Coach and develop direct reports and super-users, strengthening leadership capability and fostering a culture of continuous improvement.
• Ensure seamless execution of cross-functional initiatives aligned with global objectives and enterprise risk management priorities, securing necessary resources and aligning finance and HR strategies to support QA initiatives.
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Education & Experience

• Bachelor's Degree or Master Degree/PhD (preferred).
• 10 or more years of experience in drug development and the pharmaceutical industry, with substantial involvement in regulated GxP activities.

Skills and additional Requirements

• Fluency in English (oral and written); other languages a plus.
• Broad understanding of global Health Authority expectations.
• Extensive knowledge of ICH-GCP, GMP, FDA/EU/PMDA regulations, pharmacovigilance, new drug regulations, and current industry practice.
• Demonstrated leadership and accomplishments in global/matrix environments, successfully leading high-impact organizations or projects at senior director or equivalent level.
• Proven ability to work cross-functionally and build collaborative relationships across regions.
• Excellent verbal and written communication skills, with strong interpersonal and negotiation abilities.
• Advanced problem-solving, decision-making, and conflict-resolution skills.
• Strong project management capabilities and organizational awareness of interdepartmental priorities.
• Ability to travel globally as required