Associate Director, Quality Assurance

US PharmaLab Inc.; North Brunswick Township (NJ); On-site; USD 125,000 - 141,000; Full time

Job summary

USPL is seeking an Associate Director, Quality Assurance Compliance to lead GMP/GLP programs and drive regulatory inspection readiness in North Brunswick, NJ.

You will develop and strengthen QA processes, oversee audits, CAPA, and cross‑functional collaboration to ensure sustainable compliance and operational excellence. This exempt role reports to the Vice President of Quality Assurance and requires a hands‑on, strategic QA leader with 10–12 years of industry experience.

Qualifications

• Bachelor’s degree or higher in science or related disciplines.
• About 10-12 years of relevant work experience in dietary supplement, nutraceutical, food, pharmaceutical, or biotech industry with QA/QC experience in Dietary Supplement GMP manufacturing or CDMO environment.
• PCQI certification is required; auditing, FSMA, HACCP or related certifications preferred.

Responsibilities

• Develop and maintain GXP required SOPs and related documents; approve SOPs ensuring control of GXP operations.
• Assist in / or perform periodic reviews of programs including vendor qualification management and annual quality management reviews; assist internal audits.
• Manage customer specifications, COAs, SDS, labels and related technical documents per product development direction.
• Oversee review/approval of Food Safety Plans, validation/verification protocols and related reports.
• Lead audits and provide support during external audits; drive CAPA and corrective actions.

Skills

GXP knowledge

Audit readiness

Leadership

Regulatory compliance

Education

Bachelor’s degree or higher in science

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Associate Director, Quality Assurance

Full Time Level 1 North Brunswick, NJ, US

Salary Range: $125,000.00 To $140,500.00 Annually

Job Description

Date

2026

Location

1300 Airport Rd, North Brunswick NJ

Title

Associate Director, Quality Assurance Compliance

Department

Quality Assurance

Reports to

Vice President, Quality Assurance

FLSA (Exempt or Non-Exempt

Exempt

Role Overview

The Associate Director of Quality Assurance Compliance is responsible for developing, maintaining, and continuously strengthening Quality Compliance programs, QA procedures, GMP and GLP compliance, regulatory inspection readiness, product testing support, quality planning, and continuous improvement initiatives. This role provides leadership and direction to the QA team while driving practical upgrades to GMP practices, procedures, documentation standards, and inspection readiness across the organization.

Areas of Responsibility

• Develop and maintain GXP required Standard Operating Procedures (SOPs) and other required documents in line with industry and regulatory requirements. Author and/or approve required SOPs ensuring control of GXP operations and activities.
• Assist in / or perform periodic reviews of all established programs including Vendor qualification Management, Quality Agreements, Annual Quality Management Reviews, and in the performance of internal audits of quality-controlled activities as executed by other departments.
• Management and preparation, review and /or approval of customer specifications and other related technical documents as per customer requirements per Product Development direction
• Management of product specifications, COAs, SDS, review of product label and supplement facts
• Review and/or approval of Food Safety Plan, Validation, Verification protocols, reports, and other quality related documents.
• Oversee the day -to-day activities of the quality assurance team in line with industry and regulatory requirements, provide GMP training, mentoring and performance management.
• Provide assistance to Quality management during audits performed by external groups, customers and regulatory agencies. Develop action plans to resolve documented observations and ensure adequate resolutions are achieved.
• Lead Quality Compliance initiatives to meet current GMP expectations and proactively upgrade GMP practices, procedures, documentation, training, and inspection readiness systems to support sustainable compliance and operational excellence.
• Own preparation, hosting, coordination, response management, and follow-up for external third-party audits including GMP, Kosher, Halal, Organic, customer audits, and regulatory inspections or audits by agencies such as State authorities, FDA, TGA, and other applicable regulatory bodies.
• Manage internal and external audits, ensuring that findings are addressed, and corrective actions are implemented in a timely manner.
• Document, resolve or provide assistance to other groups with Corrective Actions, Deviations, Non- Conformance, Customer Complaints and Change Controls.
• Approve actions as necessary and monitor for effectiveness and timeliness of completion.
• Assures the implementation of GMP procedures throughout the company.
• Collaborate with cross – functional teams including production, engineering, supply chain and customer service, to identify and resolve quality issues.
• Develop and implement quality metrics and KPI’s, regularly report on performance to management.
• To perform any other tasks as given by the management

Requirements/Preferred

Education & Qualification:

• Bachelor’s Degree or higher in science or related scientific disciplines
• About 10-12 years of relevant work experience in the dietary supplement, nutraceutical, food, pharmaceutical, or biotech industry, with strong preference for hands‑on Quality Assurance and Quality Compliance experience in a Dietary Supplement GMP manufacturing or CDMO environment.
• Or equivalent combination of education and experience

Certifications, Licenses, Credentials:

• PCQI certification is required. Certifications in auditing, FSMA, HACCP, or other applicable quality and food safety programs are preferred.

Skills & Ability

• Strong knowledge of Dietary Supplement GMP requirements and compliance expectations, including 21 CFR Part 111, 21 CFR Part 117, GLP principles, and applicable electronic records expectations such as 21 CFR Part 11.
• Experience in preparation of compliance documents for product approval by customer, transition from product development / R&D stage to commercial quality systems and operations as per product specification & quality requirements.
• Hands‑on experience with implementing and managing Quality Compliance systems and processes, experience in handling internal and external audits.
• Demonstrated ability to lead audit readiness programs, manage external third‑party and regulatory audits, prepare effective audit responses, drive CAPA completion, and use audit outcomes to improve GMP systems and procedures.
• Strong leadership and interpersonal skills, problem solving skills, verbal, and written communication skills, with the ability to identify and resolve quality issues.

Physical Requirement

• The employee is frequently required to sit (50%), stand, and walk (50%). Useshands to finger, handle or feel writing tools and computer keyboard. May reach with hands and arms and infrequently may lift up to 30lbs. Use desk telephone/cell phone to talk and hear or converse with other employees.

Work Environment (Office, Warehouse, temperature extremes, etc.)

• Primarily located in an office environment where temperatures are controlled for heat and air conditioning; occasionally walks through warehouse or manufacturing workplace and will be required to wear appropriate PPE for each work area including safety shoes, hair net, safety glasses, face mask, gloves, or disposable jumpsuit.

The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all the job responsibilities, duties, skill, or working conditions. In addition, thisdocument does not create an employment contract, implied or otherwise, other than an "at will" relationship.

USPL is proud to be an Equal Opportunity Employer.

Qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity or expression, national origin, age, genetic information, disability, protected veteran status, or any other characteristic protected by applicable local, state, or federal law.

Job Description Acknowledgement

I have read and understand the job requirements, responsibilities, and expectations set forth in the job description provided for my position. I attest that I can perform the essential job functions as outlined with or without any reasonable accommodation.