Sr. Quality Manager

iLABS (Innovation Labs) Inc.; Mahwah (NJ); On-site; USD 150,000 - 210,000; Full time

Benefits offered by this job

Health benefits package

401(k) match

Paid time off

Birthday celebrations

Daily subsidized meals

Job summary

iLABS (Innovation Labs) Inc. in Mahwah, NJ is seeking a Sr. Quality Manager to lead Quality Assurance, Quality Control, and Microbiology across cosmetics, OTC drugs, and dietary supplements.

You will partner with manufacturing, R&D, Regulatory, and external partners to ensure product quality and regulatory compliance. The role oversees audits and inspections, drives continuous improvement, maintains QMS, and guides risk management, CAPAs, and supplier quality.

Qualifications

• Bachelor's degree in Life Sciences or related field required; advanced degree preferred.
• 8+ years of progressive Quality Management experience in regulated manufacturing (cosmetics/OTC/dietary supplements).
• Strong knowledge of 21 CFR Parts 210/211, 111, 820 and ISO standards; FDA inspections experience a plus.

Responsibilities

• Lead QA, QC, and Microbiology with focus on product quality and regulatory compliance.
• Direct audits, inspections readiness, deviations, CAPAs, and change controls.
• Oversee QMS, supplier quality, lab controls, and risk-based quality system enhancements.
• Mentor QA/QC team and collaborate cross-functionally with Manufacturing, R&D, Regulatory.

Skills

Quality Management

Regulatory Compliance

Audits & Inspections

Leadership & Team Building

cGMPs & FDA Regulations

Quality Systems (QMS/LIMS/eQMS)

Education

Bachelor's degree in Life Sciences or related field

Master's degree preferred

Tools

eQMS

LIMS

ERP systems

CAPA management tools

Job description

The Sr. Quality Manager leads Quality Assurance, Quality Control, and Microbiology for cosmetics, OTC drugs, dietary supplements, partnering with internal teams, external stakeholders and other third-party partners to ensure product quality, compliance, and continuous improvement.

This role leads the quality teams, oversees compliance, supports audits and inspections, and promotes quality excellence. It also ensures effective quality systems and compliant product manufacture, testing, release, and distribution under 21 CFR Parts 210/211, 111, and 820, MoCRA, customer specifications and company procedures, supporting safety, efficacy, and customer satisfaction.

Quality Assurance (QA)

• Lead and maintain the QMS across all product categories, ensuring compliance with applicable FDA, ISO, and cGMP requirements and effective control of policies, procedures, specifications, records, and other quality documentation.
• Direct regulatory, certification, customer, supplier, and internal audits, including inspection readiness, responses, and Management Representative responsibilities.
• Oversee deviations, complaints, change controls, CAPAs, recalls, and major investigations, ensuring timely, scientifically sound root-cause analysis, corrective action, and risk escalation.
• Provide quality oversight for product development, technology transfer, qualification, validation, laboratory methods and controls, computerized systems, environmental monitoring, water systems, stability, and retain-sample programs.
• Manage supplier qualification and performance, quality agreements, third-party laboratories, quality metrics, management reviews, product quality reviews, and risks associated with products, processes, facilities, suppliers, and operational changes.
• Build and develop a qualified, well-resourced Quality team and foster decisions grounded in consumer safety, product quality, scientific evidence, and regulatory compliance.

Quality Control (QC) and Microbiological Functions

• Oversee in-coming materials (Raw ingredients and components), in-process, bulk, finished product, stability and microbial testing in accordance with regulatory requirements.
• Ensure laboratory operations follow USP, and compendial methods.
• Approve specifications, test methods, and analytical results.
• Maintain calibration and qualification of QC laboratory equipment.
• Implement effective sampling plans and statistical quality control practices.

Leadership & Cross-Functional Collaboration

• Lead and mentor the QA/QC team, fostering a culture of accountability, continuous improvement, and compliance.
• Partner with Manufacturing, R&D, Regulatory, Supply Chain, and Operations to ensure quality is built into all processes.
• Train and develop employees on cGMPs, ISO standards, and company quality policies.
• Report key quality metrics and trends to senior leadership.

The Sr. Quality Manager leads Quality Assurance, Quality Control, and Microbiology for cosmetics, OTC drugs, dietary supplements, partnering with internal teams, external stakeholders and other third-party partners to ensure product quality, compliance, and continuous improvement.

This role leads the quality teams, oversees compliance, supports audits and inspections, and promotes quality excellence. It also ensures effective quality systems and compliant product manufacture, testing, release, and distribution under 21 CFR Parts 210/211, 111, and 820, MoCRA, customer specifications and company procedures, supporting safety, efficacy, and customer satisfaction.

Quality Assurance (QA)

• Lead and maintain the QMS across all product categories, ensuring compliance with applicable FDA, ISO, and cGMP requirements and effective control of policies, procedures, specifications, records, and other quality documentation.

• Direct regulatory, certification, customer, supplier, and internal audits, including inspection readiness, responses, and Management Representative responsibilities.
• Oversee deviations, complaints, change controls, CAPAs, recalls, and major investigations, ensuring timely, scientifically sound root-cause analysis, corrective action, and risk escalation.
• Provide quality oversight for product development, technology transfer, qualification, validation, laboratory methods and controls, computerized systems, environmental monitoring, water systems, stability, and retain-sample programs.
• Manage supplier qualification and performance, quality agreements, third-party laboratories, quality metrics, management reviews, product quality reviews, and risks associated with products, processes, facilities, suppliers, and operational changes.
• Build and develop a qualified, well-resourced Quality team and foster decisions grounded in consumer safety, product quality, scientific evidence, and regulatory compliance.

Quality Control (QC) and Microbiological Functions

• Oversee in-coming materials (Raw ingredients and components), in-process, bulk, finished product, stability and microbial testing in accordance with regulatory requirements.
• Ensure laboratory operations follow USP, and compendial methods.
• Approve specifications, test methods, and analytical results.
• Maintain calibration and qualification of QC laboratory equipment.
• Implement effective sampling plans and statistical quality control practices.

Leadership & Cross-Functional Collaboration

• Lead and mentor the QA/QC team, fostering a culture of accountability, continuous improvement, and compliance.
• Partner with Manufacturing, R&D, Regulatory, Supply Chain, and Operations to ensure quality is built into all processes.
• Train and develop employees on cGMPs, ISO standards, and company quality policies.
• Report key quality metrics and trends to senior leadership.

Requirements

Education

• Bachelor's degree in Life Sciences, Chemistry, Pharmaceutical Sciences, Engineering, or related field (Master's degree preferred).

Experience

• 8 + years of progressive Quality Management experience in a regulated manufacturing environment (OTC drugs, cosmetics, dietary supplements, or medical devices).
• Strong working knowledge of 21 CFR 210/211, 111, 820, ISO 13485, and Cosmetic GMPs (ISO 22716 preferred).
• Experience with FDA inspections, ISO audits, and third-party audits, demonstrated success in investigations, CAPA Management, change control, validation, supplier quality, laboratory controls, product disposition, risk-based quality systems, and continuous improvement initiatives.
• Proven leadership, coaching, conflict resolution, and team-development abilities.

Skills

• Strong knowledge of cGMPs and risk-based quality systems.
• Sound technical and regulatory judgment in product quality decisions.
• Clear communicator who effectively conveys quality risks and collaborates at all organizational levels.
• Organized, accountable, and adaptable in fast-paced environments; proficiency with eQMS, LIMS, or ERP systems is preferred

Benefits

• Comprehensive Health Benefits package (Medical, Dental, Vision, Life, AD&D)

• Competitive 401(k) match

• Paid time off (Vacation, Sick, Holiday, Summer Fridays)
• Monthly birthday celebrations + other fun activities!

• Daily subsidized meals

iLABS (Innovation Labs) Inc. is an equal opportunity employer. We do not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other characteristic protected by federal, state or local laws. All employment is decided on the basis of qualifications, merit, and business need.