Are you a seasoned professional with a passion for upholding the highest standards of quality and compliance within a dynamic environment? Akintola Williams Deloitte, the esteemed Nigerian member firm of Deloitte Touche Tohmatsu Limited (DTTL) and the oldest indigenous professional services firm in Nigeria, invites highly skilled and dedicated individuals to join our team as a Quality & Compliance Manager.
Established in 1952 by Mr. Akintola Williams, FCA, CFR, CBE, the doyen of the accountancy profession in Nigeria, Deloitte Nigeria has a rich legacy of professional excellence and a deep commitment to corporate responsibility, shaping society through the exceptional service we provide to our clients.
Job Purpose
The successful Quality & Compliance Manager will be the cornerstone in ensuring unwavering adherence to stringent regulatory standards, ethical guidelines, and our robust internal policies and procedures. This pivotal role demands an individual with an intricate understanding of regulatory landscapes, an exceptional eye for detail, and impeccable communication skills to navigate complex compliance requirements.
Core Responsibilities
Regulatory Compliance
- Monitor Regulatory Changes: Proactively track and stay abreast of the latest regulatory shifts and evolving industry standards, including those from key bodies such as FDA, ISO, and other relevant regulatory frameworks pertinent to our operations.
- Conduct Internal Audits: Lead and execute thorough internal audits to comprehensively assess compliance with both external regulatory requirements and our internal policies and Standard Operating Procedures (SOPs).
- Develop Compliance Programs: Design, implement, and continuously refine comprehensive compliance programs, encompassing our code of conduct, anti-bribery and corruption policies, and critical data privacy policies.
- Oversee Regulatory Approvals: Manage and oversee the entire regulatory approval process for new products, devices, and clinical trials, ensuring all submissions are timely and complete.
- Respond to Inquiries: Serve as the primary point of contact for regulatory agencies, responding to inquiries and requests for information in a precise, accurate, and timely manner.
Quality Assurance
- Implement Quality Management Systems: Establish, maintain, and enhance robust quality management systems, such as ISO 13485, to drive operational excellence.
- Ensure Product and Service Quality: Champion the quality of products and services through the implementation of rigorous quality control processes and continuous improvement initiatives.
- Monitor Supplier Quality: Oversee and manage the quality performance and compliance of our suppliers, ensuring they meet Deloitte's high standards.
- Manage Product Recalls: Develop and implement clear, effective procedures for managing potential product recalls, ensuring swift and compliant action.
Data Privacy and Security
- Ensure Data Privacy Compliance: Guarantee full compliance with critical data privacy regulations, including NDPR, safeguarding sensitive information.
- Implement Data Security Measures: Deploy and enforce robust data security measures designed to protect confidential patient information from unauthorized access or breaches.
- Develop Breach Response Plan: Create and regularly update a comprehensive data breach response plan to effectively manage and mitigate the impact of any security incidents.
Risk Management
- Conduct Risk Assessment: Proactively identify, analyze, and assess potential compliance risks across all operations.
- Develop Mitigation Strategies: Formulate and execute effective strategies and controls to mitigate identified compliance risks.
- Monitor Risk Assessments: Continuously monitor and review risk assessments and the efficacy of implemented mitigation plans.
Training and Education
- Deliver Compliance Training: Design and deliver engaging and informative compliance training programs for employees across all organizational levels.
- Promote Ethical Culture: Actively foster and promote a strong culture of compliance and ethical behavior throughout the firm.
- Manage Documentation: Oversee and control all essential documentation, including SOPs, work instructions, and critical records, ensuring accuracy and accessibility.
Qualifications
Educational Requirements
- A Bachelor’s degree in Law, Business, Healthcare Administration, or a closely related field is essential.
- A Master’s degree will be considered a significant advantage.
Professional Requirements
- Certification in Healthcare Compliance is a mandatory requirement for this role.
Experience Requirements
- Candidates must possess 6 - 8 years of progressive experience in compliance, quality assurance, or regulatory affairs, specifically within the medical device or pharmaceutical industry.
- A strong foundational understanding of healthcare operations, regulations, and ethics is critical.
Competency Requirements
Knowledge Requirements
- Medical Terminology: Proficiency in medical terminology to facilitate effective communication with healthcare professionals and patients.
- Medical Conditions: A basic understanding of common medical conditions and treatments relevant to the industry.
- NDPR Regulations: In-depth knowledge of NDPR regulations and best practices for handling patient information confidentially and securely.
Skill Requirements
- Communication & Interpersonal: Excellent communication and interpersonal skills to interact effectively with both clients and internal staff.
- Problem-Solving: Strong problem-solving skills, capable of resolving complex compliance issues efficiently.
- Attention to Detail & Multitasking: Exceptional attention to detail combined with the ability to manage multiple priorities and tasks simultaneously.
Personal Abilities
- Demonstrates a highly professional attitude towards work and responsibilities.
- Actively shares and embodies the vision of Akintola Williams Deloitte.
- Proactive, highly organized, and capable of independent initiative.
- Possesses strong personal and professional credibility, earning the respect of colleagues and peers.
- Supportive and approachable, fostering a collaborative work environment.
- Exhibits a strong ability to adapt quickly to changing circumstances and demands.
- Maintains exceptionally high levels of honesty and integrity in all dealings.
Method of Application
Interested and qualified? Go to Deloitte on jobs.smartrecruiters.com to apply