Manager- Regulatory & Quality

Management Solutions International, Inc.

Job Description

Job Title: Manager - Regulatory & Quality

Reporting To: Head of Operations.

Job Summary:

This role provides strong regulatory oversight to ensure compliance with MOCRA, USFDA Cosmetic regulations, and US market requirements , while supporting product development, technology transfer, and continuous improvement initiatives.

Also responsible for leading quality systems, quality operations, supplier quality, and audit readiness for all the US Namaste Products.

Qualifications, Experience & Skills:

Master's degree in chemistry, Pharmacy, Biotechnology, Microbiology or related discipline .
10-12 years of experience in Cosmetics, Personal Care, FMCG, or Pharmaceutical Manufacturing , with US market exposure.
Strong working knowledge of MOCRA, USFDA cosmetic regulations (21 CFR), GMP, and quality systems .
Experience supporting or handling USFDA inspections, observations, and regulatory queries .
Proficiency in ERP/SAP, QMS, Safety Data sheet, and documentation control systems .
Prior experience in R&D, validation, technology transfer, or NPD preferred.
Knowledge of CPNP (EU), SCPN (UK), and global cosmetic regulations .
Strong analytical, documentation, communication, and stakeholder management skills.

Key Responsibilities:

Regulatory & Market Compliance:

Ensure site-level compliance with MOCRA requirements, including GMP alignment, record retention, adverse event handling support, and inspection readiness.
Act as the quality focal point for USFDA-related interactions, audits, and inspections.
Supports USFDA clearance of shipments, addressing quality, documentation, or compliance queries.
Review and ensure compliance of Raw material specifications, formulations, and finished products with US regulatory requirements.
Ensure label review and compliance (Ingredients, Claims, warnings) in coordination with Regulatory Affairs.
Maintain inspection-ready documentation and support timely response to USFDA observations (483s), inquiries, and follow-ups.

R&D and New Product Development:

Collaborate closely with R&D to support new product trials, scale-up, and formula transfer to other manufacturing locations / 3Ps.
Provide quality input on formula design, ingredient selection, packaging compatibility, and stability studies .
Support troubleshooting, investigations, and process optimization for new and existing products.
Ensure R&D documentation aligns with quality systems and regulatory expectations .

Quality Assurance and Audit & Compliance:

Coordinate and support internal and external audits
Ensure continuous compliance with GMP, product quality, quality systems, and applicable regulatory standards .
Manage and review supplier quality documentation , ensuring alignment across the supply chain.
Support regulatory inspections and customer audits, including USFDA - related interactions where applicable.

Continuous Improvement:

Drive continuous improvement initiatives to enhance product quality, process efficiency, and cost optimization.

Key Competencies:

Quality leadership & decision-making
Regulatory & compliance expertise
Cross-functional collaboration
Risk assessment & problem-solving
Strong documentation & communication skills

Apply

Vacancy posted 3 days ago

Similar jobs that could be interesting for youBased on the Manager- Regulatory & Quality in Chicago, IL vacancy

Senior Manager, Food Safety & Quality Compliance
$124.8k - $187.2k
...time Location: IL Oak Brook Job Type: Quality Job Posting Title: Senior Manager, Food Safety & Quality Compliance About Us:... ...include resolving compliance-related issues, reviewing regulatory matters, and providing food safety guidance to the company...
Suggested
Full time
Work at office
Immediate start
Shift work
Day shift
TreeHouse Foods
Oak Brook, IL
2 days ago
Post-Market Quality Manager: Regulatory & Improvement Lead
$116k - $174k
Medline is seeking a Manager Quality - Post Market in Chicago, IL, to oversee quality and compliance for the Operating Room product division. Key responsibilities include ensuring regulatory compliance, managing complaints, and executing continuous improvement projects....
Suggested
Medline
Chicago, IL
2 days ago
Director, Quality & Regulatory Compliance
$135k - $180k
...proving that great ideas, collaboration and quality turn possibilities into success. Working... ...The Director of Quality & Regulatory Compliance is responsible for overseeing... ...implementing the organization's total quality management system. This role involves developing, executing...
Suggested
Temporary work
Work at office
Local area
Menasha Corporation
Alsip, IL
3 days ago
Quality Assurance & Compliance Manager
...challenges. And we perform with MORE Pride—in focusing on safety and quality, and in offering more opportunities for our communities and... ...Overview To oversee, plan, coordinate and implement the management of project teams to ensure they are complying with company quality...
Suggested
Contract work
For subcontractor
F.H. Paschen
Chicago, IL
4 days ago
Quality Control Manager - Lead Lab, Compliance & QA
$95k - $120k
CPS Inc. is looking for a Quality Control Manager in Chicago, Illinois. The role involves directing all aspects of Quality Control, including testing, compliance, and team management. Candidates should have a Bachelor's degree in a related field and 4-8 years of relevant...
Suggested
CPS Inc.
Chicago, IL
18 hours ago
Manager, Regulatory Submissions
$110k - $150k
...deliver actionable insights, is building a regulatory team to develop regulated medical... ...and seek FDA marketing authorization. The Manager of Regulatory Affairs will work closely with scientists, engineers, clinicians, quality professionals, and the legal team to support...
Tempus AI, Inc.
Chicago, IL
18 hours ago
Sr Manager, Regulatory Relations
$143.5k - $212.85k
Job Summary PayPal is seeking a Senior Manager to join its Global Regulatory Relations team. The role provides leadership and judgment in cultivating positive regulatory relationships, enabling PayPal's business objectives, and leading complex projects that address regulatory...
Local area
PayPal
Chicago, IL
3 days ago
Manager, Quality
$90,500 - $110,100 per week
...Manager, Quality DP World Contract Logistics delivers tailored, scalable and progressive solutions to customers in more than 100 global locations. The company has managed supply chain synergies for global automotive and technology premier brands for more than 60 years...
Bi-weekly pay
Contract work
Temporary work
Work experience placement
Local area
All shifts
Syncreon International Group
Melrose Park, IL
4 days ago
Senior Manager, Quality Management Systems
...Senior Manager Over Quality Management Systems - Healthcare We are the leading provider of worldwide smart end-to-end supply chain & logistics... ...site teams, regional logistics, external partners, and regulatory authorities, coordinating efforts to maintain certification...
Full time
Local area
Worldwide
We One
Chicago, IL
4 days ago
Manager, Quality & Insights
$115k - $122k
...Manager, QA At Grubhub, we champion restaurants from coast to coast. Restaurants sit at the heart of... ...Opportunity The Manager, QA leads Wonder's Process and Quality Insights teams, driving operational excellence and regulatory compliance in Customer Experience (CX) across...
Work at office
Local area
Shift work
3 days per week
Wonder
Chicago, IL
8 days ago
Manager - Quality
$102.22k - $133.19k
...to life with innovative architectures, data analytics, and digital solutions. Job overview and responsibilities As a Quality Engineering Manager of Information Technology at United, you will be responsible for the delivery of excellence through strategic resource planning...
Hourly pay
Shift work
United Airlines
Chicago, IL
3 days ago
Manager, Regulatory Change Management
...of the Fortune 500, we are a leader in underwriting and risk management services for business partners across the United States and Canada... ...Overview: This is a structure to drive the future state of regulatory compliance while maintaining continuity of key operational...
Local area
Shift work
Old Republic
Chicago, IL
3 days ago
Sr. Manager, Regulatory Reporting
...they are and what they contribute. To learn more about CIBC, please visit CIBC.com ( What you'll be doing The Senior Manager, Regulatory Reporting supports the Head of Regulatory Reporting in the preparation, review, and submission of U.S. regulatory reports for...
Remote work
Flexible hours
3 days per week
CIBC
Chicago, IL
2 days ago
Program Manager, Quality Specification
$85k - $95k
..., WIP, and finished goods. Integrate regulatory, customer, supply chain, risk assessment... ...compliant specifications. Establish and manage specification maintenance and... ...What You’ll Bring Five or more years of quality assurance experience, including direct experience...
Flexible hours
Van Drunen Farms
Chicago, IL
18 hours ago
Manager, Oracle Fusion Manufacturing & Quality
...consider a career in Advisory. KPMG is currently seeking a Manager in Enterprise Solutions for our Consulting practice. Responsibilities... ...Chain implementation projects specific to Manufacturing and Quality and Schedule to Produce. Design and implement process changes...
H1b
Work at office
Local area
KPMG
Chicago, IL
18 hours ago
Manager Quality (Post Market) - Operating Room
$116k - $174k
...Job Summary We have an immediate opening for a Manager Quality - Post Market supporting our Operating Room product division. Responsible... ...challenges. Job Description Responsibilities: Ensure quality and regulatory compliance with applicable regulations (ex. QSR, GMP,ISO)...
Minimum wage
Work experience placement
Work at office
Local area
Immediate start
Worldwide
Medline Industries
Chicago, IL
1 day ago
Senior Manager, Operational Risk Testing & Compliance
$112k - $210k
A leading financial services institution seeks a Senior Manager for its Compliance Risk Management team in Chicago. The role involves leading a team, overseeing risk evaluations, and ensuring compliance with financial regulations. Ideal candidates will have over 6 years...
Flexible hours
KeyBank
Chicago, IL
2 days ago
Program Manager, Quality and Clinical Process Improvement
$38.67 - $59.94 per hour
..., industry standards and payor/external regulatory rating systems. Interprets and reports... ...and Process Improvement Project Management Manages performance and process improvement... ...develop proactive approached to enhance quality, safety, and outcomes. Engage executive...
Hourly pay
Full time
Part time
For contractors
Work experience placement
Local area
Monday to Friday
Endeavor Health
Franklin Park, IL
1 day ago
Senior Manager - Supplier Quality
$170.3k - $225.64k
...divh2Senior Manager - Supplier Quality/h2pHours:/pp8:00 am 5:00 pm (Mon-Fri) On-Site/ppCompensation:/ppAt SC, we are dedicated to providing competitive and equitable compensation for all our team members, and we are committed to transparency in our pay practices. The...
Local area
SC Electric Company
Chicago, IL
3 days ago
Sr. Compliance Manager - Operational Risk Testing
$112k - $210k
...second line of defense Compliance Risk Management function, the Risk Evaluation and Assurance... ...of Key’s operations and compliance with regulatory requirements. Individuals work both... ...providing ongoing coaching, and driving quality of work for the team while ensuring any...
Work at office
Flexible hours
Shift work
KeyCorp
Chicago, IL
3 days ago
Inpatient Phlebotomy Manager - Quality & Ops Leadership
A leading healthcare provider is seeking a Manager of Phlebotomy in Chicago to enhance quality strategies and improve patient satisfaction. Responsibilities include managing human resources, overseeing patient care operations, and ensuring compliance with standards. The...
Northwestern Medicine
Chicago, IL
4 days ago
Manager, Regulatory Practices - Enterprise Services Risk
$149.8k - $171k
...Manager, Regulatory Practices - Enterprise Services Risk The Enterprise Services Risk organization is expanding with a focus on attracting... ...participate in regulatory engagements through documentation and quality assurance review of evidence (submitted to the examiners)...
Full time
Part time
Local area
Capital One
Chicago, IL
4 days ago
Data Center Quality Manager — QC & Compliance
Ryan Companies US Inc is seeking a Quality Control Manager to join our Mission Critical sector team in Chicago, Illinois. This role requires at least 5 years of experience in field quality management, specifically in large, complex construction projects. You will implement...
Ryan Companies US Inc
Chicago, IL
4 days ago
Section Manager - Environmental & Regulatory Compliance (Chicago)
$100k - $250k
...Description The Environmental & Regulatory Compliance (ERC) Section Manager is responsible for the supervision, training, and direction of ERC staff in... ...Advocate for safety in the department. Drive a culture of quality and continual improvement. Provide overall...
Full time
Temporary work
Work experience placement
Work at office
Local area
Burns & McDonnell
Chicago, IL
6 days ago
Sr. Manager, Regulatory Reporting
...CPA or advanced degree preferred.* You possess 8-10+ years of regulatory reporting experience within a financial institution or public... ...regulatory reports and instructions.* You have prior experience managing or mentoring staff, including coordination with offshore or...
Canadian Imperial Bank of Commerce
Chicago, IL
18 hours ago
Senior Manager, Regulatory Governance & Controls
$102k - $190k
Le Bank of Montreal à Chicago est à la recherche d'un spécialiste de la gouvernance financière. Vous serez chargé de développer et de maintenir un cadre efficace de gouvernance financière, fournissant des conseils stratégiques à la direction. Les candidats doivent avoir...
Bank of Montreal
Chicago, IL
3 days ago
Sr. Manager, Regulatory Reporting
$125k - $165k
Responsibilities Prepare, review and submit assigned U.S. regulatory reports, including FR Y-9C, FFIEC 031/041, and Call Reports, in accordance... ...compliance with internal governance and control frameworks. Manage day‑to‑day regulatory reporting activities, including...
Remote work
CIBC US
Chicago, IL
2 days ago
Sr. Manager, HR - Quality
$120.8k - $151k
...Senior Hr Manager, Quality You will be responsible for driving efforts in people strategies, talent development, change management and organizational efficiency in the Food Safety & Quality team in North America. You will play a critical role in shaping an exceptional...
Flexible hours
Kraft Heinz Company
Chicago, IL
4 days ago
Retirement Plan Compliance Manager
$80k - $120k
...regulations and other applicable federal laws. Adhere to audit protocol to ensure accuracy of documentation. Document Production/Management: Adhere to document production timelines to ensure efficiency and timely document production. Organize and maintain plan...
Temporary work
Work at office
Local area
Visa sponsorship
Work visa
Flexible hours
WTW inc.
Chicago, IL
3 days ago
Manager, Quality Assurance Auditor
...Job Summary The Manager, Quality Assurance Auditor is responsible for scheduling and leading domestic and international Corporate and... ...Medical Device Reports (MDR) as required to comply with all regulatory obligations. Create reports used for Key Process Indicators...
Permanent employment
Contract work
Work visa
Flexible hours
3 days per week
Fresenius Kabi USA, LLC
Melrose Park, IL
1 day ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Manager- Regulatory & Quality. Be the first to apply!