Sr Manager Operations DI lead

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Job Function:
Supply Chain Engineering

Job Sub Function:
Quality Engineering

Job Category:
Scientific/Technology

All Job Posting Locations:
Titusville, New Jersey, United States of America

Job Description:

Job Description

The Senior Manager Operations Data Integrity Lead drives the Data Integrity and Data Governance framework for Biotherapeutics Operations, translating global requirements, regulatory expectations, and remediation priorities into practical standards, risk-based controls, governance routines, and measurable improvements.

The role reports to the Sr.

Director Biotherapeutics Operations, with a dotted line to the Site Data Integrity Lead, and partners with Quality, Site Compliance, GET/JJT Automation, MSAT, QC, System Owners, and Operations leaders.

As Operations SPOC for Data Integrity, the role provides matrix leadership to System Owners, SMEs, project leads, and mapping teams to embed DI expectations into shopfloor and support-process ways of working.

Success Measures

• Operations DI risks are identified, prioritized, remediated, and governed transparently.

• Interim controls cover high-risk systems and data processes during remediation and fewer DI (recurrent) issues persist.

• Data/process-flow maps and risk assessments are completed for priority systems and critical flows.

• Leaders, system owners, and SMEs can explain DI controls during audits and inspections.

• DI governance embedded in routine Operations and QMS processes.

Leadership Behavior

• Leads with ownership, urgency, and transparency.

• Turns compliance expectations into practical execution and strengthens GMP discipline.

• Builds trust across Operations, Quality, Compliance, and technical teams.

• Challenges gaps constructively and drives risk-, data-, and patient-based decisions.

• Role-models Credo-based leadership, inclusion, accountability, and continuous improvement.

Key Responsibilities

1.

Own and drive the Operations Compliance Programme

• Act as SPOC for Operations Compliance, partnering with Quality, IMRC and Operations leadership.

• Drive compliance ownership, documentation discipline, escalation practices ...