Lead MSA SOP Strategy & External Envir in Leeds

Location: Leeds, West Yorkshire, United Kingdom

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).
• Assess regulatory and guidance changes for applicability and business impact; summarise implications and recommend 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, operationalise, 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 prioritise revisions based on regulatory‑driven changes, 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 organisations.
• Knowledge and application of clinical regulations and standards applied in different clinical areas and regions is required.

Preferred Qualifications:

• Experience within a medical device or MedTech organisation.
• 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.