Senior Manager, Data Quality & Integrity (Global R&D & PV QA) (m/f/d)

Purpose of the function

Location: Germany / Switzerland

The Senior Manager, Data Quality and Integrity (Global RandD and PV QA) provides strategic and tactical leadership for quality assurance governance of data integrity and GxP computerized systems across RandD, Pharmacovigilance (PV), and Medical Affairs (MA), with emphasis on business operational data. This role leads cross‑functional initiatives, establishes program‑level oversight frameworks, mentors and develops QA capability, and partners with senior stakeholders to ensure robust data governance, regulatory compliance, and measurable continuous improvement.

Leadership and Strategy Execution

• Lead execution of key elements of the global Data Integrity strategy and ensure alignment across RandD, PV, and MA.
• Translate strategic objectives into multi‑year roadmaps and annual operating plans for data integrity and computerized systems oversight (business operational data focus).
• Serve as a senior subject matter expert for data integrity and GxP computerized systems governance, advising leadership on risk‑based prioritization and compliance posture.

Quality and Compliance Oversight

• Provide QA leadership for high‑risk or complex GxP computerized systems and related business operational data processes across the system lifecycle.
• Oversee risk‑based validation, periodic review, change governance, and sustained compliance activities; drive consistent application of global QA standards.
• Establish and monitor portfolio‑level compliance oversight mechanisms (governance forums, escalation pathways, decision rights) for inspection readiness.

Audit, Inspection and Risk Management

• Lead QA activities for audits and regulatory inspections related to computerized systems and data integrity; coordinate cross‑functional readiness and responses.
• Review and approve investigations, deviations, and CAPAs for complex/high‑impact issues; ensure root cause quality and effectiveness verification.
• Identify, trend, and mitigate emerging compliance risks; drive proactive risk reduction actions across functions and vendors.

Stakeholder Engagement and People Leadership

• Partner with senior stakeholders across RandD, PV, MA, IT, and Global QMS/eCompliance to drive alignment on governance, priorities, and risk acceptance.
• Provide coaching and mentoring to QA staff and/or cross‑functional teams; support capability building and adoption of consistent DI practices.
• Lead cross‑functional teams to deliver complex initiatives and resolve escalations that span multiple organizations or regions.

Continuous Improvement and Innovation

• Drive continuous improvement initiatives using metrics, analytics, and trend insights to improve DI performance and inspection readiness.
• Support adoption of advanced analytics, AI‑enabled solutions, and emerging technologies to strengthen QA oversight and enable digital transformation in Global R&D and PV QA.

Education & Experience

• • Bachelor’s degree in Life Sciences, Pharmacy, IT, or related field required. Master’s degree or higher preferred.
• • 7–10 years of experience in Quality Assurance, IT compliance/CSV, and/or regulated pharmaceutical environments supporting R&D, PV, and MA.

Skills and Additional Requirements

• Demonstrated leadership of complex, cross‑functional and multi‑regional initiatives in data integrity and GxP computerized systems governance at portfolio/program level.
• Proven ability to set strategic direction and translate it into roadmaps, operating plans, and measurable outcomes, balancing competing priorities with risk‑based decision‑making.
• Strong experience in audit and inspection readiness, including oversight of investigations and approval of CAPA strategies for high‑impact issues.
• Deep expertise in enterprise risk management, with the ability to anticipate emerging risks, drive preventive actions, and ensure effective resolution of critical issues.
• Experience operating in global, matrixed organizations, with a track record of influencing senior stakeholders and driving alignment on governance and compliance.
• Excellent executive communication skills, able to clearly articulate risk, strategy, and compliance expectations to both technical and non‑technical audiences.
• Demonstrated people leadership, including coaching, mentoring, and building sustainable QA capabilities through standardization, training, and continuous learning.
• Data‑driven and improvement‑focused, leveraging metrics, trend analysis, analytics, and emerging technologies (including AI) to enhance QA oversight, data integrity, and inspection readiness.
• Fluency in English and German (both written and spoken); additional languages are an advantage.