Manager, Compliance Risk Mgmt.

Johnson & Johnson Johnson & Johnson · Pharma · Raynham, MA +1

Manager, Compliance Risk Management role within Quality Assurance at Johnson & Johnson (DePuy Synthes) focused on identifying, assessing, and managing compliance risks in a regulated medical device environment. Responsibilities include developing risk management processes, partnering with cross-functional teams, supporting audits, analyzing data for emerging risks, and driving continuous improvement.

What you'd actually do

  1. Lead compliance risk management activities, including identification, assessment, mitigation, and monitoring of quality and regulatory risks.
  2. Develop and maintain risk management processes aligned with quality system and regulatory requirements.
  3. Partner with cross‑functional teams to integrate risk‑based thinking into operational and quality decision‑making.
  4. Support internal and external audits and inspections by preparing risk assessments, documentation, and responses.
  5. Analyze trends, metrics, and quality data to identify emerging compliance risks and improvement opportunities.

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.

Nice to have

  • 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.
  • Advanced degree preferred.
  • Quality or compliance‑related certification (e.g., ASQ, RAC) preferred.

What the JD emphasized

  • regulated industry (medical device preferred)
  • quality systems
  • compliance risk management
  • regulatory expectations
  • audits
  • inspections
  • risk
  • quality data
  • compliance risks
  • quality system effectiveness
  • FDA
  • ISO