Associate Director, Quality Assurance

USPL NUTRITIONALS•North Brunswick, NJ

1d•Onsite

About The Position

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.

Requirements

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
PCQI certification is required.
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.

Nice To Haves

Certifications in auditing, FSMA, HACCP, or other applicable quality and food safety programs are preferred.

Responsibilities

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

Benefits

medical
dental
vision
short- and long-term disability
basic life insurance
supplemental life insurance
AD&D insurance
matched 401(k) savings plan
premium pay such as overtime, shift differential, holiday pay, sick time
up to 10 days of vacation in the first year, which grows to 12 days starting the second year of employment