Manager, Standards Compliance

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Quality Job Sub Function: Quality Systems Job Category: Professional All Job Posting Locations: Warsaw, Indiana, United States of America Job Description: 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.

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.

Education: Bachelor’s degree in Engineering, Quality, Life Sciences, Manufacturing, or a related discipline (required). Experience and Skills: 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. Preferred: 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.

Preferred Skills: Analytical Reasoning, Analytics Dashboards, Collaboration, Compliance Management, Data Gathering and Analysis, Data Quality, Incident Management, Performance Measurement, Process Improvements, Quality Control (QC), Quality Management Systems (QMS), Quality Services, Quality