Associate Director, Quality Assurance

Associate Director, Quality Assurance ComplianceDate - 2026 - Location - 1300 Airport Rd, North Brunswick NJTitle - Associate Director, Quality Assurance Compliance - Department - Quality AssuranceReports to - Vice President, Quality Assurance - FLSA (Exempt or Non-Exempt - ExemptRole OverviewThe 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 ResponsibilityDevelop 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 managementRequirements/PreferredEducation & 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 experienceCertifications, 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%). Uses hands 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, this document 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.Benefits And Compensation: Our benefits are designed to help you move forward in your career, and in areas of your life outside of USPL. From health and wellness benefit options including medical, dental, vision, short- and long-term disability, basic life insurance, supplemental life insurance, AD&D insurance. We also offer a matched 401(k) savings plan. Employees have the opportunity to receive compensation in the form of premium pay such as overtime, shift differential, holiday pay, sick time, etc. Newly hired employees receive up to 10 days of vacation in the first year, which grows to 12 days starting the second year of employment.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. Biofarma Srl