Associate, Compliance

Company Overview

ADMA Biologics is a biopharmaceutical company dedicated to developing superior products for immunodeficient patients at risk of infection. Our commitment to this underserved population drives our innovation and hands‑on approach to production and development, setting us apart in the industry.

The Compliance Associate is responsible for providing GxP (GMP/GLP/GDP) compliance oversight for the organization.

• Act as a liaison for ethics and compliance support adhering to critical business activities within our US market, including activities planned by Commercial, Medical Affairs, and Government Affairs teams.
• Execute and help manage paper, field, and program auditing and monitoring activities.
• Organize and evaluate facts and evidence and draw sound conclusions in relation to auditing and monitoring activities and processes.
• Prepare timely, accurate, and complete reports with corrective action recommendations and follow‑through with key stakeholders for implementation.
• Assist in the development, preparation, and management of periodic reporting of results to senior management.
• Assist in the maintenance of ADMA’s compliance program, including, but not limited to, the company’s commercial compliance policies and procedures.
• Ensure compliance with internal policies, standards and procedures and external laws and regulations, including environmental health and safety programs for the company.
• Monitor all state and federal regulations affecting pharmaceutical personnel and report on upcoming changes in federal and/or state laws.
• Compose and disseminate standardized internal communications to personnel on important compliance developments, company policies, and procedures.
• Assist with investigation of alleged violations of compliance policies, laws, regulations, or procedures.
• Ensure adequate GAp analyses are performed for new/revised Corporate and Division documents; implement changes as appropriate.
• Assists with all state, federal & regulatory inspections and information requests.
• Supports all compliance responsibilities; supports the preparation, revision, and implementation of relevant SOPs.
• Remain current with emerging regulatory trends and changes in regulations and standards to incorporate into the business to ensure ongoing compliance.

• Ability to follow the cGMP procedures with great attention to detail.
• Works in high‑pressure, deadline‑driven environment.
• Demonstrated ability to achieve goals, overcome obstacles, and meet deadlines.
• Balances multiple job assignments at once with excellent time‑management skills.
• Possesses excellent oral and written communication skills with close attention to detail and accuracy to collaborate effectively with cross‑functional teams and communicate findings and recommendations.

• Bachelor’s degree in science, engineering, quality or another technical field; or high school diploma with a minimum of 4 years of experience.
• Promotional Review Committee (PRC) or Legal Medical Review (LMR) designation is a plus.

• Minimum of four years of experience in the pharmaceutical/biotechnology industry or other highly regulated industry.
• Experience acting as a liaison for ethics and compliance support within the US market, including activities planned by Commercial, Medical Affairs, and Government Affairs teams.
• Conducted a minimum of 2 to 3 external/field commercial audits.

The minimum compliance expectation for this role entails strict adherence to FDA regulations and company policies governing sales and marketing activities. This includes completion of required compliance training, accurate documentation of sales interactions, and adherence to data privacy regulations. The role requires proactive participation in compliance reviews, prompt reporting of any potential issues, and ongoing education to stay updated on relevant FDA regulations.

• 401K plan with employer match and immediate vesting.
• Medical, Vision, Life, and Dental Insurance.
• Pet Insurance.
• Company paid STD and LTD.
• Company Paid Holidays.
• 3 Weeks’ Paid Time Off (within the first year).
• Tuition Assistance (after the first year).
• Easily accessible to Tri‑Rail.
• Free Shuttle to the Boca Tri‑Rail station.

ADMA Biologics uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit https://(Use the "Apply for this Job" box below). ADMA Biologics is an Equal Opportunity Employer.

Seniority level:
Mid‑Senior level.

Employment type:

Full‑time.

Job function:
Finance and Sales.