Quality & Compliance Manager

Job Description

Job Purpose

The Quality & Compliance Manager will be responsible for ensuring adherence to regulatory standards, ethical guidelines, and internal policies and procedures. This role requires a deep understanding of regulatory requirements, strong attention to detail, and excellent communication skills.

Core Responsibilities

Regulatory Compliance

• Monitor Regulatory Changes and stay updated on the latest regulatory changes and industry standards, including FDA, ISO, and other relevant regulations.
• Conduct internal audits to assess compliance with regulatory requirements, internal policies, and standard operating procedures (SOPs).
• Develop and implement comprehensive compliance programs, including code of conduct, anti-bribery and corruption policies, and data privacy policies.
• Oversee the regulatory approval process for new products, devices, and clinical trials.
• Respond to inquiries from regulatory agencies in a timely and accurate manner.

Quality Assurance:

• Implement and maintain quality management systems, such as ISO 13485.
• Ensure the quality of products and services through rigorous quality control processes.
• Monitor and manage supplier quality performance and compliance.
• Develop and implement procedures for managing product recalls.

Data Privacy and Security:

• Ensure compliance with data privacy regulations, such as NDPR.
• Implement data security measures to protect sensitive patient information.
• Develop and implement a data breach response plan.

Risk Management

• Conduct Risk Assessment, identify and assess potential compliance risks.
• Develop and implement strategies to mitigate compliance risks.
• Monitor and review risk assessments and mitigation plans.

Training and Education

• Develop and deliver compliance training programs for employees at all levels.
• Promote a culture of compliance and ethical behavior
• Manage and control documentation, including SOPs, work instructions, and records.

Qualifications

Educational Requirements

• Bachelor’s degree in a Law, Business, Healthcare Administration, or a related field.
• Master’s degree is an added advantage.

Professional Requirements

• Certified in Healthcare Compliance

Experience Requirements

• 6 - 8 years’ experience in compliance, quality assurance, or regulatory affairs in the medical device or pharmaceutical industry.
• Strong foundation in healthcare operations, regulations, and ethics.

Competency Requirements

Knowledge Requirements

• Knowledge of medical terminology to effectively communicate with healthcare professionals and patients.
• Basic understanding of common medical conditions and treatments.
• Knowledge of NDPR regulations and how to handle patient information confidentially.

Skill Requirements

• Excellent communication and interpersonal skills to effectively interact with patients and AMCE staff.
• Problem-solving skills to resolve complex issues.
• Strong attention to detail and ability to multitask.

Personal Abilities

• Professional attitude towards work
• Shares the AMCE’s vision.
• Proactive and organized.
• Has personal and professional credibility and commands the respect of colleagues and peers. 
• Supportive and approachable.
• Ability to adapt accordingly.
• High levels of honesty and integrity

Additional Information

African Medical Centre of Excellence, Abuja (AMCE Abuja) aims to be an Employer of Choice, providing equal opportunity for everyone regardless of their background, gender, race and other protected characteristics.