Job Function: Discovery & Pre-Clinical/Clinical Development
Job Sub Function: Clinical Development & Research - Non-MD
Job Category:People Leader
All Job Posting Locations:Palm Beach Gardens, Florida, United States of America, Raynham, Massachusetts, United States of America, Warsaw, Indiana, United States of America, West Chester, Pennsylvania, United States of America
Job Description:DePuy Synthes is recruiting for a(n) Lead MSA SOP Strategy & Compliance Leader, located in in West Chester, PA, Raynam, MA, Warsaw, IN, Palm Beach Gardens, FL or Leeds, UK.
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 to establish a standalone orthopedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.
Job Overview
The Lead MSA SOP Strategy & Compliance Leader role is responsible for shaping 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 strategies remain aligned 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 enjoys operating at the intersection of regulatory intelligence, enterprise SOP governance, and cross-functional collaboration in a highly regulated medical technology environment.
Key Responsibilities
- Continuously monitor the 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 and evidence, coordinating responses to audit observations, and ensuring timely completion 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 ensure timely awareness, 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 regulatory change drivers, risk, and business needs.
- Oversee end-to-end logistics and project management for SOP updates, including coordinating drafting, redlines/markups, version control, and consolidation of feedback.
- Coordinate communication and implementation support 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, as required
- Provide input on study specific documents as requested, such as protocol, informed consent, ISO 14155 gap assessments, etc
Qualifications
Education
- Bachelor's degree required (e.g., Business, Science, Engineering, Quality, Regulatory, or related field).
- Advanced degree (e.g., Master's, 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 is required.
Preferred:
- Experience within a medical device or MedTech organization.
- Familiarity with global quality system standards and regulatory frameworks.
- Experience supporting large-scale transformation or system implementation initiatives.
- Demonstrated ability to interpret external regulations or guidance documents, and translate them into practical SOP strategies.
- Experience working in global or multi-regional roles.
- Proven ability to lead cross-functional initiatives and influence stakeholders without direct authority.
- Excellent strategic thinking, problem-solving, and decision-making skills.
- Strong written and verbal communication skills, with experience presenting to senior leaders.
Other
- Language: Proficiency in English required.
- Travel: Up to 10%, domestic and/or international.
- Certifications: Quality, Regulatory, or Compliance certifications preferred but not required.
#LI-Hybrid
#DePuySynthesCareers
Required Skills: Preferred Skills:Clinical Data Management, Clinical Evaluations, Consulting, Developing Others, Drug Discovery Development, Entrepreneurship, Good Clinical Practice (GCP), Inclusive Leadership, Leadership, Medicines and Device Development and Regulation, Operational Excellence, Regulatory Affairs Management, Relationship Building, Safety-Oriented, Scientific Research, Strategic Change, Study Management, Team Management
