Manager, Compliance Risk Management

Johnson & Johnson Innovative Medicine • Warsaw, IN

8h • Hybrid

About The Position

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.

Requirements

• Bachelor’s degree required in engineering, life sciences, or a related technical discipline.
• 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.
• English required.

Nice To Haves

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

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.

Benefits

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period10 days
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Manager