Quality Assurance Manager at Nalis Pharmaceuticals Ltd

Job Summary

• The Quality Assurance Manager holds the critical role of ensuring that all pharmaceutical products meet stringent regulatory and internal quality standards. 
• This role demands vigilance, scientific rigor, and leadership to maintain compliance with cGMP, WHO, NAFDAC, and international regulatory bodies. 
• The QA Manager is the company’s final defense against compromise, safeguarding product integrity, patient safety, and company reputation.

Key Responsibilities
Quality Management System (QMS):

• Develop, implement, and maintain QMS in alignment with regulatory standards (NAFDAC, WHO-GMP, ISO 9001).
• Ensure continuous improvement of QMS through regular audits and management reviews.

Compliance & Documentation:

• Oversee compliance with cGMP, GLP, and SOPs across production, QC, and packaging lines.
• Ensure accurate and timely documentation, batch record reviews, deviations, and change controls.

Audits & Inspections:

• Lead internal audits, host external audits (regulatory bodies, clients), and manage CAPAs.
• Prepare the site for regulatory inspections and ensure timely closure of observations.

Process & Product Oversight:

• Monitor validation of processes, cleaning, and equipment.
• Oversee product release based on conformance to specifications.

Training & Leadership:

• Train and mentor QA personnel and cross-functional teams on quality systems and cGMP updates.
• Foster a culture of quality and ownership across all departments.

Vendor & Supplier Quality:

• Evaluate and audit raw material suppliers and third-party contractors.
• Ensure traceability and quality of materials throughout the supply chain.

Educational Qualifications

• Bachelor’s Degree in Pharmacy (B.Pharm), Pharmaceutical Sciences, Microbiology, Biochemistry, or related field.
• Advanced degrees (M.Sc., MBA) in Quality Management or Regulatory Affairs are an advantage.
• Certification in ISO 9001:2015, Six Sigma, or cGMP is highly desirable.

Experience:

• Minimum 5 - 7 years of relevant experience in QA/QC in a pharmaceutical manufacturing environment.
• At least 2 years in a supervisory or managerial role.
• Proven experience managing regulatory inspections and internal audits.
• Familiarity with sterile and non-sterile production environments is a plus.

 Other Requirements:

• Must be registered with relevant professional bodies (e.g., PCN, NAFDAC-recognised body).
• Must be conversant with national and international pharmaceutical laws and regulations.
• Must exhibit ethical integrity and professional discretion.
• Flexibility to work extended hours when required.
• Strong leadership presence and ability to make high-stakes decisions under pressure.

Required Skills and Competencies:

• Deep knowledge of current Good Manufacturing Practices (cGMP), quality control principles, and pharmaceutical regulations.
• Strong analytical and problem-solving skills.
• High attention to detail and documentation accuracy.
• Excellent communication and interpersonal skills.
• Proficiency in Quality Management Software and ERP systems (e.g., Odoo, SAP, TrackWise).
• Ability to lead under pressure and drive cross-functional coordination.
• Root Cause Analysis (RCA) and risk management expertise.