Baden-Württemberg: Head of Global Quality Systems (m/w/d) - bis zu 75% Remote

Unserem langjährigen Kunden, hat uns mit der exklusiven Suche nach einem passenden Kandidaten für die folgende Position beauftragt:

Head of Global Quality Systems (m/w/d)

Standort: bei Stuttgart
Home Office: bis zu 75%

In dieser anspruchsvollen Rolle übernehmen Sie die globale Verantwortung für die strategische Weiterentwicklung und Steuerung der Quality Systems.

Aufgaben

• Develop and implement robust quality management systems, policies, and procedures to meet regulatory requirements, including Good Manufacturing Practices (GMP), Good Distribution Practice (GDP) and Good Clinical Practices (GCP).
• Ensure the company’s quality systems are compliant with applicable local, regional, and international regulations, such as FDA, EMA, and ICH guidelines.
• Ensure the fulfillment of the quality and GxP requirements for Service Providers through the team QU-Service Provider Management.
• Ensure the performance of the processes of ‘Change Control’, ‘Deviations and Complaints’ as well as ‘Document and Learning”
• Ensure conduct of regular internal audits and self-assessments to identify areas for improvement and drive corrective actions.
• Monitor and interpret regulatory guidelines and industry trends to ensure the company remains updated on evolving quality and compliance requirements.
• Collaborate with regulatory affairs teams to support regulatory submissions and provide necessary quality documentation for product approvals.
• Lead inspections and audits conducted by regulatory authorities, addressing any identified non-conformances and implementing corrective actions.
• Ensure the global roll-out, maintenance and regular auditing of the Global Quality Management System at any entity inside
• Drive a culture of continuous improvement by implementing quality metrics, key performance indicators (KPIs), and monitoring systems to assess the effectiveness of quality systems. Result-oriented management based on trend analyses and tracking the execution of action plans.
• Foster a proactive approach to quality by promoting risk management methodologies and the use of quality tools, such as root cause analysis, Failure Mode and Effects Analysis (FMEA), and Quality by Design (QbD).
• Ensure Amplexor, the eQMS of WP, is efficiently used across all processes, regularly updated and the quality team is trained adequately. Host the Amplexor system Administrator in the Quality Systems Department.
• Ensure expertise and capacity for CSV via the Quality Systems department

Qualifikation

• Bachelor’s or Master’s degree in pharmacy or a related scientific discipline. Advanced degree (phD) is preferred.
• Extensive experience (8+ years) in quality management within the pharmaceutical industry, with a focus on quality systems.
• Thorough understanding of pharmaceutical regulations and guidelines, such as FDA, EMA, AMG, AMWHV, ANVISA, EAEU and ICH.
• Proven track record of leading and implementing quality systems in compliance with regulatory requirements.
• Strong knowledge of quality assurance principles, practices, and tools.
• Experience in managing and conducting audits and inspections by regulatory authorities.
• Excellent leadership and team management skills, with the ability to motivate and develop a team of quality professionals.
• Strong analytical and problem-solving abilities, with a proactive approach to identifying and addressing quality issues.
• Effective communication and interpersonal skills, with the ability to collaborate with and influence cross-functional stakeholders.
• User proficiency of the common MS-Office programs and familiarity with quality-relevant IT systems (e.g. document management, eQMS, CAQ, ERP) as well as CSV-know how is expected.
• You have a high degree of responsibility, result orientation and self-reliance as well as the ability to develop and implement process improvements
• Strong communication skills on all levels of cooperation, also in English, rounds off your profile

Benefits

• A dynamic, international environment with the opportunity to take on responsibility quickly and extensively, to contribute experience and knowledge and to implement ideas
• Varied challenges, as well as exciting projects with a strong team spirit
• Central company headquarters with good public transport connections, as well as mobility allowances
• A wide range of opportunities for personal and professional development
• Regular employee events
• Compensation in line with the market and your performance, as well as additional benefits which can be used flexibly according to your needs, e.g.,
• Subsidy for direct insurance
• Individual compensation options for days off, pension provisions or payout
• Bonago vouchers for special occasions
• Support for your general well-being and/or work-life balance
• Health-promoting measures such as discounted conditions on over-the-counter (OTC) pharmacy products or health days.

Contact:

Mariana Chaumont
Senior Consultant
Tel.: 0049-(0)89-80913072-0

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