Sr. Quality Manager

the ASSURANCE group; New Jersey; On-site; USD 130,000 - 170,000; Full time

Job summary

the ASSURANCE group is seeking a Director/Sr. Quality Manager to lead Quality Assurance, Quality Control, and Microbiology for cosmetics, OTC drugs, dietary supplements, and Class II medical devices.

You will partner with internal teams and external partners to ensure product quality and compliance. You will build a high-performing quality organization, drive CAPA, change controls, and risk assessments, and oversee audits, investigations, and laboratory testing programs across the product

Qualifications

• Bachelor's degree in Life Sciences or related field; master's preferred.
• 8+ years of quality management experience in a regulated manufacturing environment.
• Strong knowledge of 21 CFR Parts 210/211, 111, and 820; ISO 13485; and cosmetic GMPs. ISO 22716 experience preferred.
• Experience supporting FDA inspections, ISO certifications, and customer or third-party audits.
• Proven expertise in CAPA, investigations, change control, validation, supplier quality, laboratory controls, risk management, and continuous improvement.
• Strong leadership, communication, coaching, and cross-functional collaboration skills.

Responsibilities

• Lead QA, QC, and Microbiology operations and develop a high-performing Quality team.
• Maintain compliance with FDA, ISO, cGMP, MoCRA, customer, and company requirements.
• Oversee audits, inspections, CAPAs, deviations, complaints, change controls, recalls, and investigations.
• Direct laboratory testing, specifications, analytical methods, environmental monitoring, stability, validation, and equipment qualification programs.
• Manage supplier quality, third-party laboratories, quality agreements, management reviews, risk assessments, and product disposition.
• Partner with Manufacturing, R&D, Regulatory, Supply Chain, and Operations to embed quality throughout the product lifecycle.
• Report quality metrics, trends, and risks to senior leadership.

Skills

QA Leadership

Cross-functional leadership

Regulatory knowledge

Audit management

CAPA & investigations

Supplier quality

LIMS/eQMS experience

Education

Bachelor's degree in Life Sciences or related

Master's preferred

Tools

eQMS

LIMS

ERP systems

Job description

Leading contract manufacturer is seeking a collaborative Director/Sr. Quality Manager of Quality to lead Quality Assurance, Quality Control, and Microbiology for cosmetics, OTC drugs, dietary supplements, and Class II medical devices, partnering with internal teams, external stakeholders and other third-party partners to ensure product quality, compliance, and continuous improvement.

Key Responsibilities

• Lead QA, QC, and Microbiology operations and develop a high-performing Quality team.
• Maintain compliance with FDA, ISO, cGMP, MoCRA, customer, and company requirements.
• Oversee audits, inspections, CAPAs, deviations, complaints, change controls, recalls, and investigations.
• Direct laboratory testing, specifications, analytical methods, environmental monitoring, stability, validation, and equipment qualification programs.
• Manage supplier quality, third-party laboratories, quality agreements, management reviews, risk assessments, and product disposition.
• Partner with Manufacturing, R&D, Regulatory, Supply Chain, and Operations to embed quality throughout the product lifecycle.
• Report quality metrics, trends, and risks to senior leadership.

Qualifications

• Bachelor's degree in Life Sciences, Chemistry, Pharmaceutical Sciences, Engineering, or a related field; master's preferred.
• 8+ years of progressive quality management experience in a regulated manufacturing environment.
• Strong knowledge of 21 CFR Parts 210/211, 111, and 820; ISO 13485; and cosmetic GMPs. ISO 22716 experience is preferred.
• Experience supporting FDA inspections, ISO certifications, and customer or third-party audits.
• Proven expertise in CAPA, investigations, change control, validation, supplier quality, laboratory controls, risk management, and continuous improvement.
• Strong leadership, communication, coaching, and cross-functional collaboration skills.
• Experience with eQMS, LIMS, or ERP systems is preferred.