Onsite Quality Assurance Manager

About Us:

Uniphar, founded in 1967, is a leading, global, full-service life sciences and healthcare services company that has grown and expanded its operations internationally across Europe, the USA, MENA and APAC. Working from clinical development to commercialization, our end-to-end services remove barriers to launch, increase access and optimize brands. Capabilities span across consulting, communications, global supply chain, regulatory compliance, medical affairs, medical communications, medical information, field (msl, sales, virtual), access, agency, research, digital, and in-licensing. We have over 3.5K employees, $3 billion in annual revenue, over 200+ multinational partners, and deliver medications to more than 180 countries. Uniphar US operations include integrated services from Uniphar Clinical, Uniphar Logistics, Uniphar Medical, and Uniphar Commercial including Access and Supply chain. We deliver exceptional results driven by trust, innovation, and our patient-first culture. Check out our EVP and why you should work for us: https://uniphar.euwest01.umbraco.io/media/44rfphln/uniphar-pharma_evp_2024_pdf_v2.pdf

US Uniphar Website:

www.uniphar.us Why Join Us?

• Competitive salary
• Comprehensive benefits: health, dental, vision, 401(k) match, and more
• A collaborative, flexible work environment that supports career growth
• Opportunity to make a global impact in the dynamic life sciences industry Uniphar is seeking an experienced Quality Assurance Manager to provide site‑wide quality leadership in a regulated GxP packaging, labeling, storage, and distribution environment.

This role is responsible for ensuring compliance with FDA, DEA, and ISO requirements, with a strong focus on controlled substances, medical devices, electronic records, and quality systems. The Quality Assurance Manager will oversee batch record review and product release, lead regulatory compliance activities, support audits and inspections, and drive training and quality culture across the site. This role partners closely with operations and leadership to ensure all activities consistently meet federal, state, and local regulatory expectations.

Key Responsibilities:

Provide quality oversight for GxP operations, including drugs and medical devices Approve master and executed batch records and support product release decisions Ensure compliance with FDA and DEA regulations, including ARCOS and controlled substance reporting Maintain accurate, compliant documentation and electronic records (21 CFR Part 11) Support internal and external audits, inspections, and CAPA activities Oversee controlled substance inventory management, security, and disposal Lead GxP training, SOP adherence, and quality culture initiatives

Qualifications:

Bachelor's degree required 7+ years of Quality Assurance experience in a regulated life‑sciences environment Strong experience with cGMP, controlled substances, FDA/DEA regulations, and

ISO 13485

Proven ability to manage audits, inspections, and regulatory documentation Excellent organizational, communication, and decision‑making skills Top 3 skills required for this role:

• GxP Regulatory Compliance & Controlled Substance Oversight
• Expert‑level knowledge of FDA and DEA regulations, including 21 CFR Parts 210/211, 212, 11, 820/QMSR, 1340 (ARCOS) and

ISO 13485

2016, with hands‑on experience managing controlled substances across their full lifecycle (receipt, storage, documentation, reporting, and disposal).

• Quality Systems & Risk Management
• Strong capability in batch record review and product release, documentation control, CAPA, audit readiness, and inspection management within a regulated packaging, labeling, storage, and distribution environment.
• Leadership, Training & Communication
• Proven ability to train, qualify, and influence cross‑functional teams, build and sustain a strong quality culture, and clearly communicate regulatory expectations, SOP requirements, and compliance risks.

Physical Requirements:

Mobility:

Must be able to sit frequently and stand or walk occasionally.

Equipment Operation:

Occasional operation of a forklift is required.

Lifting:

Must be able to lift up to 10 lbs frequently and 25-50 lbs occasionally.

Body Movements:

Occasional bending, squatting, crawling, reaching above shoulder level, and climbing.

Manual Dexterity:

Frequent grasping, pushing, pulling, and fine manipulation.

Foot Controls:

Must be able to use both feet for repetitive actions.

Work Environment:

Exposure to moderate noise levels. An employee must meet the physical demands described here to perform the essential functions of this job successfully. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. Equal Opportunity Employer Uniphar recognizes the right of an individual to work and to advance on the basis of merit, ability, and potential. It is the policy of Uniphar to ensure that job applicants are considered, and that employees are treated during employment, without regard to their race, color, religion, creed, sex, national origin, age, physical or mental disability, veteran status or Vietnam-Era veteran status, citizenship, marital status, domestic partnership status, familial status, gender identity, sexual orientation, legally protected medical condition (including pregnancy, childbirth, or related medical condition), genetic characteristics or other characteristic, condition or classification protected by federal, state, or local law. Uniphar is committed to the principles of equal opportunity and resolves to ensure equal opportunity in all employment practices.

Benefits:

401(k) matching Dental insurance Health insurance Life insurance

Work Location:

In person