Manager, Standards Compliance

Johnson & Johnson Innovative Medicine • Warsaw, IN

3d • Onsite

About The Position

The Manager, Standards Compliance provides leadership for ensuring manufacturing operations remain aligned with applicable standards, regulations, and internal policies. This role oversees the monitoring and tracking of emerging regulations and standards, and changes impacting the business. The position has a direct impact on product quality, patient safety, audit readiness, and operational excellence and partners closely with Manufacturing, Quality, Engineering, and Regulatory teams.

Requirements

• Bachelor’s degree in Engineering, Quality, Life Sciences, Manufacturing, or a related discipline (required).
• Typically 6-8 years of progressive experience in manufacturing quality, regulations and standards compliance, or related roles with deep knowledge of applicable regulatory requirements.
• Strong working knowledge of quality system requirements, regulations and standards applicable to medical device or pharmaceutical environments.
• Knowledge of US, EU and MDSAP country regulatory frameworks.
• Experience supporting audits, inspections, and regulatory interactions.
• Proven ability to translate standards and regulations into practical production controls.
• Strong analytical, problem‑solving, and risk‑assessment skills.
• Effective communication and cross‑functional collaboration skills.

Nice To Haves

• Experience in medical devices, healthcare, or other highly regulated manufacturing environments.
• Experience working in a matrixed or multinational organization.
• Prior leadership experience guiding compliance or quality initiatives in production settings.

Responsibilities

• Design, development and implementation of the standards management process within the regulatory intelligence program.
• Own and facilitate the regulations and standards change management and assessment process.
• Monitor regulatory changes throughout the product lifecycle with specific focus on regulations and standards associated with the QMS and regulatory filings.
• Development, tracking and trending of metrics for the standards management process
• Interpret external standards, regulations, and internal quality requirements and translate them into production‑ready processes and controls.
• Facilitate the assessment of regulations and standards changes by partnering with subject matter experts to ensure compliant implementation.
• Support internal and external audits, inspections, and assessments related to the standards compliance process.
• Provide guidance, training, and oversight on the process and platform.
• Drive continuous improvement initiatives to strengthen compliance, consistency, and operational effectiveness.

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