Job Description:
Overview:
The External Supply & LOC Quality Manager oversees quality assurance processes related to external contract manufacturers and the pharmaceutical industry's local operating companies (LOC). This role ensures compliance with regulatory requirements, company standards, and best practices to ensure the quality and safety of pharmaceutical products.
Key Responsibilities:
1-Contract Manufacturer & LOC Management:
Develop and maintain a quality management system with contract manufacturers and LOCs according to the latest regulatory requirements
Conduct regular audits and inspections to ensure compliance with Good Manufacturing Practices (GMP), regulatory requirements, and company standards.
Evaluate and approve new contract manufacturers based on established quality criteria.
2-Quality Assurance and Compliance:
Ensure adherence to relevant regulatory guidelines and industry standards (e.g., FDA, EMA, ICH) among external partners.
Review and approve quality agreements, Standard Operating Procedures (SOPs), batch disposition, and other documentation provided by external partners.
Monitor and manage quality-related issues, including deviations, non-conformances, batch releases, and product recalls, in collaboration with external partners.
Participate in Product tech transfer to actively update and implement operational controls in batch records, ensuring alignment with production processes and regulatory standards
Provide regular oversight of the external CMO by approving deviations and change controls, reviewing OOS and complaint investigations, overseeing Julphar production campaigns, and conducting APQR for manufactured products.
Coordinate with the CMO quality team to prepare the site for the Julphar routine audit, ensuring all relevant documentation, facilities, and personnel are thoroughly organized and ready for compliance verification
3-Performance Monitoring:
Track and analyse key performance indicators (KPIs) related to external quality.
Prepare and present regular reports on quality performance, compliance status, and initiatives for improvement.
4-Continuous Improvement:
Identify opportunities for improvement in the quality management processes of external partners.
Collaborate with external partners to implement corrective and preventive actions (CAPAs) and other quality improvement initiatives.
5-Training and Support:
Provide guidance and support to external partners regarding quality-related matters.
Conduct training sessions to ensure external partners remain informed about regulatory changes and quality requirements.
6-Regulatory and Documentation Management:
Maintain up-to-date knowledge of regulatory changes and industry trends impacting external quality management.
Ensure that all documentation related to external quality is complete, accurate, and compliant with regulatory standards.
Qualifications:
Bachelor’s degree in Pharmacy, Chemistry, Biochemistry, or a related field. A Master’s degree or higher qualification is preferred.
Professional certification in Quality Management or a related field (e.g., ASQ Certified Quality Manager) is a plus.
A minimum of 7 years of experience in quality management within the pharmaceutical industry, with a focus on external quality assurance.
In-depth knowledge of GMP, FDA regulations, and other relevant regulatory standards.
Proven experience in conducting audits and managing quality-related issues with external partners.
Willingness to travel as required for site audits and inspections.
Core Competencies:
Professional knowledge in Quality Management systems
Technical Background related to the GMP areas and strong knowledge about the Regulatory standards and audit basis.
Completed the Auditor Qualification program
Ethical and adheres to an organization code of conduct and complies with the principles of auditing as listed in ISO 19011, section 4
Risk Based Approach
Process management
High on Accountability & Ownership
Strong analytical, problem-solving, and communication skills.
Ability to work independently and manage multiple projects simultaneously.
Good Communication skills and presentation skills
Solid knowledge about Quality improvement tools and continuous improvement frameworks
High on business acumen, having a strong understanding and practice of 'cost consciousness'
Excellent in Result & Process Orientation for self and department achievement
High on adaptability and change management skills
High on resolution mindset with good decision-making skills
Excellent team building, strong time and task management for self and team