Lead MSA SOP Strategy & External Envir

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings we recommend focusing on the specific country(s) that align with your preferred location(s):

US - Requisition Number: R-071882

UK - Requisition Number:R-073360

Remember whether you apply to one or all of these requisition numbers your applications will be considered as a single submission.

Johnson & Johnson announced plans to separate our Orthopedics business toestablisha standalone orthopedics companyoperatingas DePuy Synthes. The process of the planned separation isanticipatedto be completed within 18 to24 months subject to legal requirements including consultation with works councils and other employee representative bodies as may berequired regulatory approvals and other customary conditions and approvals. Should you accept this position it isanticipatedthat following conclusion of the transaction you would be an employee of DePuySynthesand your employment would be governed by DePuy Synthes employment processes programs policies and benefit that case details of any planned changes would be provided to you by DePuy Synthes atan appropriate timeand subject to any necessary consultation processes.

Job Overview

The Lead MSA SOP Strategy & Compliance Leader roleis responsible forshaping and governing the strategic direction of Standard Operating Procedures (SOPs) across DePuy Synthes Medical and Scientific Affairs (MSA) with a strong focus on external regulatory industry and compliance environments. This role plays a leadership function in ensuring SOP strategiesremainaligned with evolving global regulations industry standards and business priorities while enabling operational excellence across the organization.

This is an impactful role for a strategic leader who enjoysoperatingat the intersection of regulatory intelligence enterprise SOP governance andcrossfunctionalcollaboration in a highly regulated medical technology environment.

Key Responsibilities

• Continuouslymonitorthe external environment for global regulations standards and guidance related to clinical trial conduct as well as Clinical Evaluation Reports (CERs) and Summary of Safety and Clinical Performance (SSCPs).

• Serve as a single point of contact and coordinate with subject matter experts in the Clinical & Medical Affairs teams to support internal and external audits by providing SOP documentation andevidence coordinating responses to audit observations and ensuringtimelycompletion of related corrective and preventive actions (CAPAs) as applicable

• Assess regulatory and guidance changes for applicability and business impact; summarize implications and recommended actions for MSA SOP strategy and operational execution.

• Serve as the primary liaison between external regulatory intelligence and internal SOP owners to ensuretimelyawareness alignment and decision-making.

• Establish operationalize and oversee the MSA SOP governance process (charter roles/responsibilities meeting cadence decision rights and documentation expectations).

• Drive strategic input and alignment from key governance functions including Clinical Research/Operations Scientific Operations (CER strategy & writing) and Medical Affairs as well as other cross-functional stakeholders as needed.

• Maintain a forward-looking SOP update roadmap and prioritize revisions based on regulatorychangedrivers risk and business needs.

• Oversee end-to-endlogisticsand project management for SOP updates including coordinating drafting redlines/markups version control and consolidation of feedback.

• Coordinate communication andimplementationsupport for SOP changes (e.g. release planning stakeholder notifications and readiness activities) in partnership with SOP owners.

• May be assigned responsibilities related to study resourcing and project management responsibilities asrequired

• Provide input on study specific documents as requested such as protocol informed consent ISO 14155 gap assessmentsetc

Qualifications

Education

• Bachelors degreerequired(e.g. Business Science Engineering Quality Regulatory or related field).

• Advanced degree (e.g. Masters MBA or equivalent) preferred.

Experience and Skills

Required:

• Typically requires 6-8 years of progressive experience in Clinical Research/Operations or Regulatory with exposure to SOP governance quality systems regulatory strategy or related functions (e.g. medical devices pharmaceuticals life sciences).

• Experience supporting external audits and inspection readiness

• Demonstrated experience leading SOP or management system strategy at an enterprise or global level.

• Strong understanding of global regulatory and external compliance environments.

• Experience working in complex matrixed organizations.

• Knowledge and application of clinical regulations and standards applied in different clinical areas and regions isrequired.

Preferred:

• Experience within a medical device or MedTech organization.

• Familiarity with global quality system standards and regulatory frameworks.

• Experience supportinglargescaletransformation or system implementation initiatives.

• Demonstrated ability to interpret external regulations or guidancedocuments andtranslate them into practical SOP strategies.

• Experience working in global ormultiregionalroles.

• Proven ability to leadcrossfunctionalinitiatives and influence stakeholders without direct authority.

• Excellent strategic thinkingproblemsolving anddecisionmakingskills.

• Strong written and verbal communication skills with experience presenting to senior leaders.

Other

• Language:Proficiencyin Englishrequired.

• Travel: Up to 10% domestic and/or international.

• Certifications: Quality Regulatory or Compliance certifications preferred but notrequired.

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