Associate, Compliance

Role Summary

Associate, Compliance based in Boca Raton, FL. This role provides GxP (GMP/GLP/GDP) compliance oversight for the organization and supports the development and maintenance of the compliance program. The position collaborates with cross-functional teams to implement corrective actions and ensure ongoing regulatory compliance.

Responsibilities

• 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, among others.
• 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.

Qualifications

• Required: A minimum of four years of experience in the pharmaceutical/biotechnology industry or other highly regulated industry.
• Required: Must have experience acting as a liaison for ethics and compliance support adhering to critical business activities within the US market, including activities planned by Commercial, Medical Affairs, and Government Affairs teams, among others.
• Required: Must have conducted a minimum of 2 to 3 external/field commercial audits.
• Preferred: Promotional Review Committee (PRC) or Legal Medical Review (LMR) designation a plus.

Skills

• Ability to follow the cGMP’s and procedures with great attention to detail
• Able to work in high-pressure, deadline-driven environment
• Demonstrated ability to achieve goals, overcome obstacles, and meet deadlines
• Possess time management skills and be able to balance multiple job assignments at once
• 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

Education

• Bachelor’s degree in science, engineering, quality or another technical field or high school diploma with a minimum of 4 years of experience is required.