Head of Investigations and Improvement
7 maanden geleden
The opportunity
Management of the Investigation & Improvement department and broad support of Operations by means of knowledge contribution, development and realization of improvement processes (by CAPA and Change control), co-realization of pharmaceutical production, challenging production processes, performing investigations (gDR) and analyzing batch documentation and batch review, in such a way that an optimal working method and product quality are guaranteed in the production process. You will manage a team of 7 professionals, 3 project managers and 4 pharmaceutical specialists.
How you’ll spend your day
Develop, implement, and manage departmental objectives aligned with our annual production plan. Provide direction and leadership for the Investigation & Improvement (I&I) team, fostering a culture of continuous improvement. Plan, prioritize, and oversee departmental activities, ensuring efficient execution and alignment with broader operational goals. Collaborate effectively with cross-functional teams (QA, RA, etc.) to identify and address production challenges. Manage and mentor a team of 9 consisting out of Project Professionals and Pharmaceutical Specialists, guiding their development and ensuring a high-performing team environment. Lead investigations into production deviations, implementing corrective actions (CAPA) to prevent recurrence. Champion a data-driven approach, analyzing processes and identifying opportunities for improvement. Participate in and prepare for inspections and audits by national and international authorities, ensuring departmental expertise is represented. Report on departmental progress and performance to senior leadership.Your experience and qualifications
Master’s degree in a relevant field (e.g., Pharmaceutical Science or Pharmacy) preferred. Candidates with a Bachelor's degree and significant proven experience will also be considered. Extensive experience in managing and leading a production-focused investigation and improvement team within the pharmaceutical industry. Proven track record of successfully implementing process improvements that enhance efficiency and product quality. Strong understanding of Good Manufacturing Practices (GMP) and regulatory requirements. Excellent analytical and problem-solving skills with a focus on root cause analysis. Exceptional communication, collaboration, and leadership abilities with a coaching approach. A passion for quality, continuous improvement, and building high-performing teams Demonstrated ability to apply scientific judgment to analyze data, solve problems, and make informed decisions in a pharmaceutical context-
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