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Quality System Compliance Manager Jobs (NOW HIRING)

Cipla

QA Compliance Manager

Fall River, MA · On-site

$86K - $113K/yr

Quality Assurance Compliance Manager Work Location : Fall River, MA Work Hours: General: 8:30AM - 5 ... site quality systems. * Monitor FDA regulatory updates and industry trends to assess impact and ...

Intuitive

Sr. Quality System Engineer

Sunnyvale, CA · On-site

Lead complex QMS compliance projects, risk assessments, remediation plans, policy implementation ... Strong technical writing, risk-based thinking, stakeholder management, executive communication, and ...

Amae Health

Quality & Compliance Manager

New York, NY

$112K - $175K/yr

Leading health systems--including NewYork-Presbyterian, Cedars-Sinai, Mass General Brigham, Novant ... We're hiring a Quality & Compliance Manager to lead and operationalize this work, with a primary ...

Amae Health

Quality & Compliance Manager

San Francisco, CA · On-site

$112K - $175K/yr

Leading health systems--including NewYork-Presbyterian, Cedars-Sinai, Mass General Brigham, Novant ... We're hiring a Quality & Compliance Manager to lead and operationalize this work, with a primary ...

Abbott

Manager, Regulatory Compliance

Plano, TX

Regulatory Compliance Manager also supports the quality system by taking action to align activities with Corporate Compliance objectives, What You'll Work On * Responsible for compliance with ...

Abbott

Manager, Regulatory Compliance

Plano, TX

Regulatory Compliance Manager also supports the quality system by taking action to align activities with Corporate Compliance objectives, What You'll Work On * Responsible for compliance with ...

BCI Management

Compliance Manager

North East, MD · On-site

$70K - $120K/yr

Your expertise will help us deliver high-quality, compliant housing solutions while fostering ... Manage audit preparations by maintaining detailed documentation and responding promptly to ...

FullSteam

Compliance Manager

Bloomfield, CT · On-site

$85K - $100K/yr

This role oversees SQF system, food safety, quality assurance, and compliance systems to protect ... Manage document control, SOPs, and work instructions related to SQF, FDA, USDA and FSMA Education ...

Lantheus

Quality Compliance Manager

North Billerica, MA · On-site

$111K - $185K/yr

Summary of role Lantheus is seeking a Manager of Quality Compliance to provide Quality Assurance expertise for the QA/QC, production and technical organizations to ensure the following: compliance to ...

Steris Corporation

Quality Manager

Saint Louis, MO · On-site

Lead the organization's Quality staff to ensure compliance to the overall Quality Management System ... and drive continuous improvement. * Lead the organization's Quality staff to ensure alignment to ...

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Quality System Compliance Manager information

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How much do quality system compliance manager jobs pay per year?

As of Jun 15, 2026, the average yearly pay for quality system compliance manager in the United States is $98,613.00, according to ZipRecruiter salary data. Most workers in this role earn between $75,500.00 and $122,500.00 per year, depending on experience, location, and employer.

What does a quality systems and compliance manager do?

A quality systems and compliance manager oversees the development, implementation, and maintenance of quality management systems to ensure products and processes meet industry standards and regulations. They conduct audits, analyze data, and implement corrective actions, often using tools like ISO standards and quality management software, to ensure ongoing compliance and continuous improvement.

What is the salary for a quality manager?

The salary for a Quality System Compliance Manager typically ranges from $70,000 to $120,000 annually, depending on experience, industry, and location. Professionals with certifications like CQE or Six Sigma may earn higher salaries, and the role often requires knowledge of quality management systems such as ISO 9001.

What is the role of a quality compliance manager?

A quality compliance manager oversees an organization’s adherence to industry standards, regulations, and internal policies to ensure product and service quality. They develop, implement, and monitor quality systems, conduct audits, and ensure compliance with certifications such as ISO, often using tools like quality management software. Strong knowledge of regulatory requirements and attention to detail are essential for this role.

How does a Quality System Compliance Manager typically collaborate with cross-functional teams to ensure regulatory adherence?

Quality System Compliance Managers routinely work with departments such as manufacturing, R&D, and regulatory affairs to align processes with quality standards and regulatory requirements. They facilitate regular meetings, provide training on compliance protocols, and lead audits to identify and address gaps. Effective communication and collaboration are essential, as these managers must interpret complex regulations and translate them into practical procedures for different teams. This cross-functional approach ensures that quality and compliance are integrated throughout the organization.

What is the difference between Quality System Compliance Manager vs Quality Assurance Specialist?

AspectQuality System Compliance ManagerQuality Assurance Specialist
CertificationsISO 9001 Lead Auditor, CQEASQ certifications, ISO 9001 awareness
Work EnvironmentRegulatory compliance, quality management systemsProduct testing, process inspection
Employer & IndustryManufacturing, healthcare, aerospaceManufacturing, software, consumer goods

The Quality System Compliance Manager focuses on ensuring organizational adherence to quality standards and regulatory requirements, often managing compliance programs. The Quality Assurance Specialist primarily conducts product testing and inspections to verify quality. While both roles aim to improve quality, the Compliance Manager emphasizes system-wide adherence, whereas the Specialist concentrates on product-level quality assurance.

Is QMS a good career?

A career as a Quality System Compliance Manager involves overseeing quality management systems (QMS) to ensure compliance with industry standards such as ISO 9001. It requires strong attention to detail, knowledge of regulatory requirements, and skills in audits and process improvement. This role offers opportunities for advancement in industries like manufacturing, healthcare, and technology, often with certifications like ISO auditor or Six Sigma enhancing career prospects.

What does a Quality System Compliance Manager do?

A Quality System Compliance Manager is responsible for ensuring that an organization’s processes and products meet regulatory and quality standards. They develop, implement, and maintain quality management systems, conduct audits, and ensure compliance with industry regulations such as ISO standards or FDA requirements. Their role often involves training staff on quality procedures, handling non-conformances, and facilitating continuous improvement initiatives to uphold product safety and efficacy.

What are the key skills and qualifications needed to thrive as a Quality System Compliance Manager, and why are they important?

To thrive as a Quality System Compliance Manager, you need a deep understanding of quality management systems, regulatory requirements (such as ISO 9001 or FDA regulations), and a relevant degree in science or engineering. Familiarity with audit software, document control systems, and certifications like Certified Quality Auditor (CQA) are typically expected. Strong analytical thinking, attention to detail, and effective communication enable success in cross-functional team environments. These competencies ensure organizational compliance, minimize risk, and drive continuous improvement in quality standards.
Infographic showing various Quality System Compliance Manager job openings in the United States as of June 2026, with employment types broken down into 1% As Needed, 81% Full Time, 15% Part Time, and 3% Contract. Highlights an 92% Physical, 2% Hybrid, and 6% Remote job distribution, with an average salary of $98,613 per year, or $47.4 per hour.

QA Compliance Manager

Cipla

Fall River, MA • On-site

$86K - $113K/yr

Full-time

Posted 18 days ago

Job description

NOTICE: The posting for local applicants only - is not for those applying for a global assignment and/or for employees working outside of Cipla's U.S. Subsidiaries or Affiliates.
Job Title: Quality Assurance Compliance Manager
Work Location: Fall River, MA
Work Hours: General: 8:30AM - 5:00PM (may vary based on business needs)
Reports To: Head of Quality Assurance
Salary Range: $86,000 - $113,500
Purpose
The QA Compliance Manager is responsible for ensuring that all compliance related activities comply with U.S. regulatory requirements, primarily governed by the U.S. Food and Drug Administration (FDA) under 21 CFR Parts 210,211 and 820 and other applicable regulations. The role focuses on maintaining inspection readiness, and ensuring adherence to Current Good Manufacturing Practice (cGMP) requirements for pharmaceutical manufacturing.
Job Responsibilities
  • Ensure timely and effective closure of all internal, external, regulatory, and customer audit observations through robust corrective and preventive actions (CAPA).
  • Independently prepare, review, and submit Field Alert Reports (FARs) in accordance with FDA regulatory requirements.
  • Lead and manage initiation and execution of product recalls at various levels, ensuring regulatory compliance and effective cross-functional coordination.
  • Oversee document control operations, ensuring accurate receipt, review, archival, and maintenance of controlled documents in compliance with data integrity and record-keeping requirements.
  • Ensure timely submission of document to iron mount.
  • Ensure document control room is managed properly and ready for all time audit.
  • Maintain continuous inspection readiness for internal, external, and regulatory audits through proactive quality oversight and compliance monitoring.
  • Develop, manage, and execute the site internal audit program, including audit scheduling, conduct, reporting, and follow-up activities.
  • Identify, investigate, and remediate site-wide data integrity issues to ensure compliance with regulatory expectations and industry best practices.
  • Ensure compliance with applicable FDA regulations, including 21 CFR Parts 210 and 211, 21 CFR Part 11 (Electronic Records and Signatures), and 21 CFR Part 820, as applicable.
  • Interpret and implement FDA guidance documents, compliance policies, and regulatory expectations across site quality systems.
  • Monitor FDA regulatory updates and industry trends to assess impact and ensure ongoing site compliance and operational readiness.
  • Serve as the primary Quality Assurance representative and lead during FDA inspections, including Pre-Approval Inspections (PAI), routine surveillance, and for-cause inspections.
  • Lead the preparation and submission of responses to FDA Form 483 observations.
  • Track and manage site-wide training activities to ensure timely completion and maintain zero overdue or pending training requirements, supporting continuous inspection readiness
  • Collaborate closely with Regulatory Affairs and cross-functional stakeholders to align inspection strategies, communication plans, and regulatory responses.
  • Review FDA Form 483 observations and ensure implementation of agreed corrective actions across the facility.
  • Coordinate cross-functional meetings to drive compliance activities, define action plans, assign responsibilities, and ensure timely completion of commitments and target completion dates (TCDs).
  • Review the deviation, CAPA and change request initiated against the audit observation to ensure the observation requirements are met.
  • Impart data integrity and GDP related training to new hire during orientation program.
  • Investigate and review the market/ product compliant for commercialized product and ensure its onetime closure as per SOP timeline.
  • Send the compliant related sample to outside vendor for investigation.
  • Any other work assigned by Head Unit Quality Assurance and Site Quality Head.

Educational & Experience:
  • Minimum of a bachelor's degree in chemistry, Pharmaceutical Sciences, QualityManagement or related field of study from an accredited institution.
  • Minimum of ten (10) years of collective work experience in QA Department, QC lab, preferably in a pharmaceutical manufacturing company preferred.
  • Minimum of two (2) years supervisory and team leadership experience, both hourly and salaried staff.
  • Working knowledge and direct application of cGMP and regulatory guidelines related to QA, pharmaceutical manufacturing, and computerized system validation, equipment validation and data integrity.
  • Relevant understanding and knowledge about CFR part 11 regulations.
  • Preferably have prior MDI experience or in Drug Device combination products.

GLOBAL COMPANY
Cipla is a leading global pharmaceutical company, dedicated to high-quality, branded and generic medicines. We are trusted by healthcare professionals and patients across geographies. Over the last eight decades, we have strengthened our leadership in India's pharmaceutical industry and fortified our promise of strengthening our global focus by consolidating and deepening our presence in the key markets of India, South Africa, the U.S., and other economies of the emerging world.Cipla employs handpicked professionals not just for their knowledge and experience but for their zeal to make a difference to the world of healthcare. The company believes that our biggest assets are the employees, who lead us to prosperity and growth in the future. Driven by the vision, none shall be denied, Cipla's focus has always been on making affordable, world-class medicines with a reputation for uncompromising quality standards across the world.
CIPLA NEW YORK (INVAGEN PHARMACEUTICALS, INC.)
About InvaGen Pharmaceuticals, a Cipla subsidiary: InvaGen Pharmaceuticals, Inc. is engaged in the development, manufacture, marketing, and distribution of generic prescription medicines with focus on a range of therapeutic areas, including cardiovascular, anti-infective, CNS, anti-inflammatory, anti-diabetic, and anti-depressants. The company was founded in 2003 and is based in Central Islip and Hauppauge, New York. As of February 18, 2016, InvaGen Pharmaceuticals, Inc. operates as a subsidiary of Cipla (EU) Limited.
EEO Statement:
Cipla is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, sex, sexual orientation, gender identity, religion, national origin, genetic information, disability, or protected veteran status.

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