Sr Manager Operations DI lead

Johnson & Johnson Innovative Medicine•Hopewell Township, NJ

1d•$122,000 - $212,750•Onsite

About The Position

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.

Requirements

Bachelor’s degree in science, engineering, biotechnology, pharmaceutical sciences, automation, quality, or a related discipline; Master’s degree preferred.
8+ years of experience in GMP-regulated manufacturing, operations, quality, automation, validation, compliance, or data integrity within biopharmaceuticals or pharmaceuticals.
Strong working knowledge of EU GMP/EudraLex, Annex 11, FDA expectations, 21 CFR Part 11 principles, ALCOA+, data lifecycle management, and computerized system controls.
Experience with deviations/NCs, CAPA, change control, audit/inspection readiness, quality risk management, validation, and batch release support.
Ability to translate compliance gaps into operational actions, governance routines, interim controls, and sustainable remediation plans.
Proven ability to lead cross-functional teams without formal authority and influence senior stakeholders in a complex manufacturing environment.
Strong written and verbal communication skills with ability to create clear, concise, defensible narratives for leadership and inspections.

Nice To Haves

Coaching
Collaboration
Controls Compliance
Fact-Based Decision Making
Financial Competence
ISO 9001
Lean Supply Chain Management
Non-Conformance Reporting (NCR)
Process Improvements
Quality Control Testing
Quality Standards
Quality Systems Documentation
Quality Validation
Science, Technology, Engineering, and Math (STEM) Application
Schematic Design
Tactical Planning
Technical Credibility

Responsibilities

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 and compliance culture across Operations.
Execute the Site Quality Plan, ensuring actions are prioritized, resourced and delivered.
Provide a clear compliance narrative to Leadership Teams, including status, trends, risks and required decisions.
Lead inspection readiness and regulatory response
Maintain continuous inspection readiness by identifying compliance vulnerabilities and ensuring timely remediation.
Coordinate internal and external inspections, including readiness assessments, interview preparation, evidence management and inspection logistics.
Own inspection responses from observation through closure, ensuring robust root cause analysis, commitments and sustainable CAPAs.
Translate regulatory requirements into operational strategy and continuous improvement
Convert regulatory expectations and compliance gaps into operational priorities, roadmaps, projects and measurable outcomes.
Anticipate evolving regulatory requirements and incorporate them into a multi-year compliance strategy.
Sponsor and drive strategic compliance initiatives to strengthen systems, processes, facilities and quality performance.
Drive risk-based decision making and governance
Identify, assess and communicate compliance risks, recommending effective mitigations.
Facilitate cross-functional prioritization, resource allocation and risk acceptance decisions.
Establish governance, escalation pathways, KPIs, dashboards and maturity metrics to drive accountability, transparency and sustained improvements.
Challenge root cause analyses and ensure corrective actions address systemic issues.