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Manager Manufacturing Compliance Jobs in Indiana

... manufacturing. This position plays a critical cross-functional role in ensuring site readiness and ongoing compliance with FDA, EMA, ICH, and applicable GMP requirements through effective management ...

Manufacturing Engineer

South Bend, IN

$71K - $92K/yr

With companies across the globe laying critical emphasis on their human resources management ... compliance, assisting with fault diagnosis, and emergency operation procedures. You will provide ...

Manufacturing Engineer

South Bend, IN · On-site

$71K - $92K/yr

With companies across the globe laying critical emphasis on their human resources management ... data for specification compliance, assisting with fault diagnosis, and emergency operation ...

Maintain a clean, organized, and safety-compliant manufacturing environment in accordance with company and OSHA standards. * Manage facility supply inventory, including raw materials and consumables ...

The Manufacturing Manager is primarily responsible for leading plant operations for a center ... Ensure compliance in all audit initiatives * Drive continuous improvement in safety, quality ...

Manufacturing Engineer

South Bend, IN · On-site

$71K - $92K/yr

With companies across the globe laying critical emphasis on their human resources management ... compliance, assisting with fault diagnosis, and emergency operation procedures. • You will ...

The Manufacturing Manager is primarily responsible for leading plant operations for a center ... Ensure compliance in all audit initiatives * Drive continuous improvement in safety, quality ...

The Manufacturing Manager is responsible for overseeing the daily operations of a manufacturing ... compliance with regulatory requirements with a continuous improvement mindset. Leadership ...

New

The Manufacturing Manager is responsible for overseeing the daily operations of a manufacturing ... compliance with regulatory requirements with a continuous improvement mindset. Leadership ...

New

... Manufacturing leadership and executive management team and develop, communicate, lead and motivate ... Ensure compliance in all audit initiatives * Drive continuous improvement in safety, quality ...

The Manufacturing Manager is responsible for overseeing the daily operations of a manufacturing ... compliance with regulatory requirements with a continuous improvement mindset. Leadership ...

Be Seen First

Champion a strong safety culture; ensure compliance with OSHA and internal safety standards ... Management, or related field (or equivalent experience) * 7-10+ years of manufacturing experience ...

Safety & Compliance * Ensure all work is performed in compliance with OSHA regulations, company ... Calibration & Tool Crib Operations For this opening, the Manufacturing Manager - First Line ...

... Manufacturing leadership and executive management team and develop, communicate, lead and motivate ... Ensure compliance in all audit initiatives * Drive continuous improvement in safety, quality ...

Showing results 21-40

Manager Manufacturing Compliance information

What is a manager manufacturing compliance?

A Manager Manufacturing Compliance is responsible for ensuring that manufacturing processes, products, and documentation adhere to regulatory and company standards. They oversee audits, implement compliance programs, and coordinate with quality assurance and production teams to address any issues. This role often requires strong knowledge of industry regulations such as FDA, ISO, or GMP, and involves continuous training and process improvement to maintain compliance. The manager also keeps up to date with changing regulations and helps prepare the company for inspections.

What are the key skills and qualifications needed to thrive as a manager manufacturing compliance?

To thrive as a Manager Manufacturing Compliance, you need in-depth knowledge of regulatory requirements, quality management systems, and a relevant degree in engineering, life sciences, or a related field. Familiarity with tools such as GMP documentation systems, CAPA software, and quality auditing certifications like Six Sigma or ISO 9001 is essential. Strong leadership, attention to detail, and effective communication skills help ensure compliance and foster a culture of continuous improvement. These skills are vital for minimizing risk, maintaining product quality, and ensuring regulatory adherence in manufacturing environments.

What are some common challenges faced by a manager manufacturing compliance, and how can they be addressed?

A Manager Manufacturing Compliance often faces challenges such as keeping up with evolving regulatory requirements, ensuring consistent adherence to quality standards across teams, and effectively communicating compliance expectations. These challenges can be addressed by staying informed through continuous training, fostering a culture of quality and transparency, and implementing robust internal audits and corrective action plans. Collaboration with cross-functional teams—like quality assurance, production, and regulatory affairs—is key to proactively identifying and resolving compliance issues before they impact operations.

What is the difference between Manager Manufacturing Compliance vs Quality Assurance Manager?

AspectManager Manufacturing ComplianceQuality Assurance Manager
CertificationsISO 9001, OSHA, Six SigmaISO 9001, Six Sigma, CQE
Work EnvironmentManufacturing plants, regulatory agenciesQuality labs, manufacturing facilities
Employer & Industry UsageManufacturing, industrial sectorsManufacturing, consumer goods, pharmaceuticals
Primary FocusEnsuring compliance with regulations and standardsMaintaining product quality and process improvements

The Manager Manufacturing Compliance primarily focuses on regulatory adherence and standards within manufacturing environments, ensuring compliance with laws and industry regulations. In contrast, the Quality Assurance Manager concentrates on product quality, process improvements, and defect prevention. Both roles require similar certifications and often work closely but serve distinct functions in manufacturing operations.

What are popular job titles related to Manager Manufacturing Compliance jobs in Indiana?

For Manager Manufacturing Compliance jobs in Indiana, the most frequently searched job titles are:

What job categories do people searching Manager Manufacturing Compliance jobs in Indiana look for?

The top searched job categories for Manager Manufacturing Compliance jobs in Indiana are:

What cities in Indiana are hiring for Manager Manufacturing Compliance jobs?

Cities in Indiana with the most Manager Manufacturing Compliance job openings:

Manager, Standards Compliance

Johnson & Johnson

Warsaw, IN • On-site

Full-time

Retirement, PTO

Posted 3 days ago

New


Johnson & Johnson rating

8.3

Company rating: 8.3 out of 10

Based on 112 frontline employees who took The Breakroom Quiz

25th of 86 rated pharmaceutical


Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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.


Key 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 productionready 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.

Qualifications 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, problemsolving, and riskassessment skills.
  • Effective communication and crossfunctional 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.

Required Skills:

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 Standards, Risk Management, System Integration, Systems Analysis, Tactical Planning, Technical Credibility

The anticipated base pay range for this position is :

153,000 USD Annual

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off 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 For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits

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