Quality Assurance Manager

Job Description - Quality Assurance Manager

(Ocean Springs, MS--Relocation Assistance Provided)

Job Title

Quality Assurance Manager

Objective

On behalf of our client, 10X is seeking a Quality Assurance Manager responsible for overseeing all Quality activities related to managing licenses, Drug Enforcement Administration (DEA) compliance, and importing and exporting licensed drug and unlicensed drug products. This role is responsible for ensuring all activities related to product procurement and distribution comply with international, federal and local regulatory requirements and company policies and procedures, maintaining the highest level of quality, compliance and safety of products.

Responsibilities

Key Responsibilities

License Management

Maintain and manage all required licenses and permits for the company’s operations, including state, federal, and international licenses.

Ensuring timely renewals and updates of licenses to avoid any operational disruptions.

Coordinate with relevant regulatory bodies to ensure compliance with all licensing and reporting requirements.

Controlled Substance Compliance

Oversee all Controlled Substance activities, ensuring compliance with DEA and state regulations

Manage systems to monitor and report controlled substance inventory, purchases, distributions, imports and exports.

Conduct regular audits and inspections to ensure DEA compliance and maintain a constant state of inspection readiness.

Liaise with the DEA and state and local regulatory agencies as necessary.

Import/Export Management

Manage all aspects of importing and exporting commercial drug products, ensuring compliance with international trade regulations.

Prepare and submit all required documentation for importing and exporting activities.

Coordinate with customs brokers, freight forwarders, and other logistics partners to ensure the timely and compliant movement of products.

Resolve any issues related to customs, shipping, and regulatory compliance.

Quality Assurance

Develop, implement, and maintain Quality Assurance systems and processes to ensure compliance with regulatory requirements.

Conduct regular internal audits and manage external supplier audits to ensure ongoing compliance with existing company procedures.

Implement and maintain a corrective and preventive actions (CAPAs) program.

Ensure all documentation and record-keeping meet regulatory standards and adhere to record retention requirements.

Team Leadership and Collaboration

Lead and manage the QA team, providing guidance, training , and performance management.

Collaborate with other departments and sites to ensure quality and compliance across the organization.

Foster a culture of continuous improvement and quality excellence.

Reporting and Documentation

Prepare and present regular reports on Quality activities, compliance status, and key metrics to senior management.

Maintain accurate and up-to-date records of all Quality activities including audits, inspections, corrective actions, and complaints.

Skills

Strong organization and project management skills

Excellent communication and interpersonal skills

Ability to lead and motivate a team

Proficiency in Quality Management Systems and software

SOP Development

Change Control

Auditing

Process Improvement

Complex Problem-Solving

Change and Growth Management

Qualifications

Education: Bachelor’s degree in a related field (e.g., Pharmacy, Chemistry, Biology)

Experience: Minimum of 5-7 years of experience in Quality Assurance within the GxP industry, with a focus on DEA compliance and import/export activities.

Knowledge: In-depth knowledge of FDA, DEA, DSCSA, and international regulations related to drug products.