Lead global quality assurance for CMOs, BD&L, transfers and launches at pharmaceutical firm Acino. Ensure GMP/GDP compliance and oversee suppliers, 3PLs, and launches.
Responsibilities
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
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