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Quality & Compliance Manager

DELOITTE CONSULTANTA SRL·Salary not specified

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ComplianceQuality Assurance

Job description

About the Position

Quality & Compliance Manager

The African Medical Centre of Excellence (AMCE) in partnership with King's College Hospital London (KCH) is seeking a talented individual to fill the role of Quality & Compliance Manager. This flagship facility in Abuja is a key part of Afreximbank’s network of healthcare facilities, aiming to revolutionize healthcare in Africa.

Responsibilities

Regulatory Compliance

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

Quality Assurance

  • Implement Quality Management Systems: Maintain quality management systems, such as ISO 13485.
  • Ensure Quality of Products and Services: Implement rigorous quality control processes to ensure the quality of products and services.
  • Monitor Supplier Quality: Manage and monitor supplier quality performance and compliance.
  • Develop Recall Procedures: Create and implement procedures for managing product recalls.

Data Privacy and Security

  • Ensure Data Privacy Compliance: Adhere to data privacy regulations, such as NDPR.
  • Implement Data Security Measures: Protect sensitive patient information with robust data security measures.
  • Develop Data Breach Response Plan: Create and implement a data breach response plan.

Risk Management

  • Conduct Risk Assessments: Identify and assess potential compliance risks.
  • Develop Risk Mitigation Strategies: Create and implement strategies to mitigate compliance risks.
  • Monitor Risk Assessments: Review and monitor risk assessments and mitigation plans.

Training and Education

  • Develop Compliance Training Programs: Create and deliver compliance training programs for employees at all levels.
  • Promote Compliance Culture: Foster a culture of compliance and ethical behavior.
  • Manage Documentation: Control documentation, including SOPs, work instructions, and records.

Requirements

Educational Requirements

  • Bachelor’s degree in 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.

We Offer

  • Opportunity to work in a pioneering healthcare facility in Africa.
  • Be part of a team committed to revolutionizing healthcare in Africa.
  • Competitive compensation package.
  • Professional growth and development opportunities.

About the Company

The African Medical Centre of Excellence (AMCE) in partnership with King's College Hospital London (KCH) aims to revolutionize healthcare in Africa. Established to address critical gaps, the AMCE Abuja is committed to providing world-class care through innovative research, development, and education. The partnership with King's College Hospital ensures global expertise, world-class clinical training, research, and professional development. The Centre will offer comprehensive services in oncology, haematology, cardiovascular care, and general healthcare across the continent, with plans for expansion.

Set to commence operations in early 2025, this flagship facility in Abuja is a key part of Afreximbank’s network of healthcare facilities, actively countering brain drain, reducing medical tourism by offering advanced procedures such as stem cell transplantation and state-of-the-art treatments for various diseases, and fostering employment opportunities. The vision for the AMCE initiative is to shape a healthier and more educated future for Africa.

Applications Close

Friday, February 21, 2025.

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