Global Head, Quality and Compliance
Novartis
Head of Quality, Supply Chain Operations
Acino
full-time
Posted on:
Location Type: Hybrid
Location: 🇪🇬 Egypt
Visit company websiteJob Level
Lead
About the role
- Provide strategic leadership and develop/implement quality strategies aligned with business objectives and regulatory expectations
- Act as quality business partner to corporate supply chain team and serve as SPOC for CMOs, BD&L, transfer projects and product launches
- Oversee quality performance of CMOs (ESO ownership), set and monitor KPIs, and provide front-line support for quality issues
- Co-design and implement ESO QMS compliant with Acino standards and local regulations
- Implement continuous improvement initiatives (Lean, Six Sigma, Kaizen) and leverage digital tools to monitor quality performance
- Oversee qualification status of CMOs and ensure ongoing training and development programs
- Participate in central working groups (Quality Review Board, Corporate Quality Review Board, Safety Board) and escalate quality issues per Acino directives
- Collaborate with BD&L for due diligence, quality assessments, and integration plans for acquisitions and partnerships
- Manage transfer project oversight for technology and manufacturing process transfers and resolve technical/quality issues
- Define and support product launch requirements, timelines, and quality objectives
- Ensure global distribution compliance, evolve SOPs and quality agreements, and qualify/monitor 3PLs and external distribution partners
- Lead product complaint investigations, root cause analysis, and interactions with distributors, 3PLs, and contract manufacturers
- Lead and develop a high-performing quality team, establish quality and data integrity culture, and drive talent development
- Develop and maintain quality governance framework, manage quality risk, support regulatory inspections and product license maintenance
Requirements
- Degree in Pharmaceutical Sciences, Chemistry, or related field; advanced degree preferred
- > 10 years practical experience in the pharmaceutical industry in quality function and different functions
- Relevant experience in manufacturing and supply chain environments
- Experience in Auditing is a plus
- Experience in international GMP requirements
- Proven leadership experience in global quality management within the pharmaceutical industry
- Proficient in managing across QC and QA organizations and implementing proper controls
- Strong understanding of regulatory requirements and quality standards (FDA, EMA, MHRA, WHO, etc.)
- Experience with quality by design and operational excellence initiatives (Lean, Six Sigma, Kaizen)
- Excellent strategic planning and organizational skills
- Ability to drive change and foster a culture of quality and compliance
ATS Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
quality managementLeanSix SigmaKaizenquality by designregulatory complianceauditingKPI monitoringroot cause analysisquality governance
Soft skills
strategic leadershiporganizational skillschange managementteam developmentcollaborationcommunicationproblem-solvingtalent developmentquality culturedata integrity
