Manager, Compliance Risk Management

Manager, Compliance Risk Management

The Manager, Compliance Risk Management is a Quality Assurance leadership role responsible for identifying, assessing, and managing compliance risks across DePuy Synthes operations. This role plays a key part in ensuring adherence to quality system requirements and regulatory expectations while enabling business execution. The position partners closely with Quality, Regulatory, Manufacturing, Supply Chain, and other cross-functional teams to proactively manage risk, support inspections, and strengthen a culture of quality and compliance.

Key Responsibilities

• Lead compliance risk management activities, including identification, assessment, mitigation, and monitoring of quality and regulatory risks.
• Develop and maintain risk management processes aligned with quality system and regulatory requirements.
• Partner with cross-functional teams to integrate risk-based thinking into operational and quality decision-making.
• Support internal and external audits and inspections by preparing risk assessments, documentation, and responses.
• Analyze trends, metrics, and quality data to identify emerging compliance risks and improvement opportunities.
• Provide guidance and training on compliance risk management principles and quality system expectations.
• Ensure effective documentation and reporting of compliance risks and mitigation actions.
• Drive continuous improvement initiatives to enhance compliance risk processes and overall quality system effectiveness.
• Communicate risk status, priorities, and recommendations to Quality and business leadership.

Qualifications

Education

• Bachelor's degree required in engineering, life sciences, or a related technical discipline.
• Advanced degree preferred.

Experience and Skills

Required:

• 6–8 years of progressive experience in Quality Assurance, Compliance, or Risk Management within a regulated industry (medical device preferred).
• Strong knowledge of quality systems, compliance risk management, and regulatory expectations.
• Experience supporting audits, inspections, and compliance-related activities.
• Demonstrated ability to assess risk, analyze data, and translate findings into actionable recommendations.
• Proven ability to work effectively in cross-functional and matrixed environments.
• Strong written and verbal communication skills, with the ability to influence and engage stakeholders.

Preferred:

• Experience in medical device quality systems and global regulatory environments.
• Prior people leadership or project leadership experience.
• Experience with risk management tools, methodologies, and quality metrics.
• Demonstrated success driving continuous improvement initiatives.
• Familiarity with FDA, ISO, and other applicable quality and regulatory standards.

Other:

• Languages:
  
  English required.
• Travel:
  Moderate, primarily domestic.
• Certifications:
  
  Quality or compliance-related certification (e.g., ASQ, RAC) preferred.