Job Description

Job Description

Job Description

Department

Quality Operations

Job Title

Compliance Manager

FLSA Status

Exempt

Reports To

Site Quality Head

1. Role Purpose:

The Compliance Manager ensures continuous adherence to current Good Manufacturing Practices (cGMP) and relevant regulatory requirements for investigational medicinal products. This role supports the site's self-inspection program, prepares for health authority inspections, and leads general GMP readiness and compliance initiatives.

2. Key Duties & Responsibilities:

• Lead and support self-inspections and inspection readiness activities across manufacturing facilities, laboratories, and support areas.

• Conduct internal audits and assessments to ensure compliance with applicable regulations.

• Issue comprehensive reports summarizing findings and track resulting Corrective and Preventive Actions (CAPAs) to satisfactory closure, maintaining appropriate risk posture for the site.

• Develop and maintain metrics and key performance indicators to measure trends and improve quality performance.

• Perform trend analyses of observations and commitments, compile trend reports, and present outcomes to management and Quality Councils.

• Maintain expert knowledge of GMP requirements and industry trends as described in applicable worldwide regulations; provide guidance and interpretation of GMP, regulatory, and compliance standards.

• Lead and support preparation activities for GMP compliance audits and health authority inspections as needed.

• Track audit and inspection commitments to closure.

• Develop and harmonize procedures and processes that promote, facilitate, and ensure compliance with domestic and international regulations and industry standards.

• Proactively identify, develop, and implement opportunities for work/process improvement and efficiency.

• Promote a culture of quality and operational excellence; proactively identify areas for improvement and collaborate across multiple organizations to implement solutions.

• Represent the Quality department on inter-departmental and cross-functional teams, ensuring effective information flow and providing quality compliance guidance.

• Develop and maintain the supplier qualification program.

• Evaluate testing procedures to ensure they meet specifications and regulatory commitments.

3. Typical Supervisory Responsibility:

Serves as an effective member of the Compliance team and may serve as a mentor to other Compliance employees.

4. Education & Experience:

Education Requirement:

Bachelor's degree in a relevant Science discipline (e.g., Chemistry, Biology, Biochemistry, Microbiology), Information Technology, or Engineering.

Experience Requirement:

• Minimum of 10 years of experience in Quality Assurance/Compliance within the pharmaceutical, biopharmaceutical/biologics, or related industry.
• Hands-on experience in QA, QC, laboratories, manufacturing, supply chain, facilities, or engineering.
• Familiarity with R&D or clinical supply processes.
• Experience leading internal/external audits and supporting health authority inspections.
• Demonstrated experience developing Quality Systems and GxP compliance within a regulated environment.

5. Technical competencies/ Certifications/ Licenses:

Technical competencies

• Extensive knowledge of GMPs, US FDA and EU GMP regulations, and ICH guidelines.
• Proficiency in applying scientific and regulatory principles to solve operational and quality tasks.
• Strong leadership skills to lead cross-functional teams.
• Experience using electronic quality systems to monitor, report, and track quality tasks and KPIs.
• Demonstrated experience using Quality Risk Management tools.
• Excellent attention to detail and proficiency in PowerPoint, Excel, and Word.
• Excellent verbal and written communication and presentation skills across all levels.
• Ability to prioritize and manage multiple priorities and projects independently.

6. Physical demand and Work environment:

a. Physical demands:

While performing the duties of this job, the employee is required to walk, sit, and use hands to finger, handle or feel tools or controls, reach with hands and arms, balance, stoop, crouch, bend, talk and hear. The employee must lift and/or move up to 20 pounds. Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, and depth perception.

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