Pharmaceutical Affairs Director - HELM Pharmaceuticals (m/f/d)

HELM Pharmaceuticals GmbH is looking for an experienced Pharmaceutical Affairs Director (m/f/d) to lead our quality and regulatory affairs activities for HELM Portugal.

Your tasks:

• In this position, you will drive cross-functional alignment, fostering integrated and lean regulatory and quality processes across departments, making sure efficiency, compliance, and a strong Quality Mindset are embedded in our daily operations.
• In doing so, you build and sustain our Pharmaceutical Affairs team by cultivating a customer-centered culture that focuses on compliance and operational excellence, always balancing internal and external customer needs with continuous improvement initiatives.
• Here, you will lead the strategic development and continuous optimization of our comprehensive Quality Management System (QMS), while ensuring it supports all operating authorizations and licenses and is adaptable to the organization’s evolving business models and market needs.
• This also includes full oversight and continuous improvement of all core QA system processes such as deviation and CAPA management, change control, risk management, complaint handling, supplier qualification, document control, training management, self-inspections, and quality metrics monitoring.
• Moreover, you will be responsible for all Regulatory Affairs activities: You will oversee all submissions, product registrations, and communications with regulatory authorities, ensuring our portfolio moves forward smoothly and compliantly. This also includes the maintaining of our licenses for wholesaling and API importation/distribution.
• Furthermore, you oversee our Master Data Management (MDM), ensuring integrity and accuracy of our master data across all systems, supporting traceability and efficient decision-making. Here, you also lead and supervise our Computer System Validation (CSV).
  
  

Your profile:

• You completed a university degree in Pharmaceutical Sciences or equivalent, ideally you have completed pharmacy studies and possess of a license to practice as a pharmacist.
• Ideally, you have already gained at least 5 years of work experience in Quality Assurance in the pharmaceutical industry.
• Furthermore, you have a strong overall quality mindset and can provide a good understanding of relevant quality regulations in our major markets.
• Moreover, you are familiar in delivering client-focused solutions based on stakeholder needs.
• Your working style is strategic, solution-oriented, and characterized by a hands-on mentality.
• You demonstrate a high level of intercultural competence and know how to lead, motivate, and develop teams across different cultural backgrounds.
• Excellent written and spoken communication skills in English complete your profile.