Manager - External Supply and LOC Quality - Julphar

Job Description:

Overview:

The External Supply & LOC Quality Manager oversees quality assurance processes related to external contract manufacturers and the pharmaceutical industrys 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:

1Contract 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.

2Quality 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 qualityrelated issues including deviations nonconformances 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

3Performance 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.

  
  

4Continuous 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.

5Training and Support:

• Provide guidance and support to external partners regarding qualityrelated matters.

• Conduct training sessions to ensure external partners remain informed about regulatory changes and quality requirements.

6Regulatory and Documentation Management:

• Maintain uptodate 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:

• Bachelors degree in Pharmacy Chemistry Biochemistry or a related field. A Masters 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.

• Indepth knowledge of GMP FDA regulations and other relevant regulatory standards.

• Proven experience in conducting audits and managing qualityrelated 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 problemsolving 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 decisionmaking skills

• Excellent team building strong time and task management for self and team