Manager Projects & Validation
Leiden (NL) | 40 hrs.
The Manager Projects & Validation is the driving force behind the Validation and Projects teams, including Operations (OPS) and Tech Transfer (TT). You’ll orchestrate the smooth execution of exciting internal and external projects at a GMP-regulated manufacturing site, keeping everything on track, compliant, and aligned with goals. If you love coordinating teams, solving challenges, and celebrating successful project deliveries, this role is for you!
Your tasks
- Lead cross-functional teams to execute projects successfully.
- Develop and manage milestone-based project plans to meet goals and deliverables.
- Coordinate departmental activities, delegate tasks, and ensure timely project completion by monitoring progress and addressing challenges.
- Analyze process performance during projects, recommend corrective actions, and drive quality and productivity improvements.
- Plan, supervise, and execute validation activities following the System Development Life Cycle (SDLC).
- Prepare and manage key validation documents, including risk assessments, user requirements, SOPs, testing protocols (IQ, OQ), and change controls.
- Act as the primary liaison between operations and project teams, translating needs into actionable project plans.
- Keep stakeholders informed with regular updates on project status.
- Oversee the performance of the Validation department and ensure successful project outcomes.
- Manage team operations, including setting objectives, evaluating performance, recruiting, and handling HR-related matters.
- Ensure all activities comply with GMP and local Quality System requirements, meeting Quality Assurance standards.
You have
- BSc or MSc degree in project management or comparable level through experience.
- Experience in life sciences (Biotechnology or related) is strongly preferred
- Knowledge of pharmaceutical GMP regulations.
- Ability to communicate effectively with customers and the matrix organization.
- Ability to interact, influence and motivate colleagues from various disciplines.
- Critical thinking skills to analyze and manage complex technical data.
- Excellent technical writing skills.
- Good command of the English language, both verbally and in writing. German / Dutch is advantageous.
Who are we looking for?
As Manager Projects & Validation you stand out through your interpersonal skills, such as collaborative leadership, effective communication, and problem-solving, as well as your industry knowledge, particularly strategic thinking and customer focus. You have the ability to deal with a variety of concrete variables in situations where only limited standardization exists.
Our offer
- You will be part of a steadily growing and dynamic biopharmaceutical company offering a great environment for self-starters.
- A culture that is characterized by entrepreneurial spirit and a friendly and helpful atmosphere. The patient’s well-being is always our top priority. This combination is the basis for an interesting and challenging environment.
- You will be working in our dynamic headquarters in Leiden, where we work on the full project pipeline from development to commercial production.
- Being part of a company that is geared towards helping people live happier and healthier lives.
- A competitive salary that matches your responsibilities and experience.
- A 13th month salary
- 30 leave days.
- Company contribution to a pension package and health insurance.
Your application
We look forward to hearing from you! We are interested in your CV, but we also want to find out more about your ambitions, your personality and what drives you to apply. So be sure to include a brief cover letter telling us why you are a match for this position. The application process consists of an introduction by the Recruiter, two interviews either via video call or live at our office in Leiden with the Hiring Manager and/or a Department Specialist followed by contract negotiations. Depending on the vacancy, an assessment could be part of the process.
Important notice to search firms and recruitment agencies
HAL Allergy does not accept unsolicited approaches from recruitment agencies and/or search firms (such as, for instance, the sending of resumes) for any job posted on this or a referring website. All recruitment agencies and search firms are required to contact HAL Allergy Recruitment via recruitment@hal-allergy.com to enquire about a potential recruitment or search agreement with HAL Allergy.
HAL Allergy, for those who seek pharmaceutical innovation
HAL Allergy is one of the European top players in the development, production and distribution of allergen immunotherapies for the treatment and prevention of allergic diseases. We focus on the development and manufacturing of modified allergen extracts for the therapeutic and diagnostic purposes of respiratory and food allergies. With all our activities the patient's well-being is always top of mind. At Hall Allergy we foster open discussions, an entrepreneurial spirit and close collaborations within the teams and with our international colleagues summing up to more than 300 highly specialized people across various positions. If you too would like to become a part of an innovative and challenging pharmaceutical manufacturer, then this is your perfect opportunity!
HAL Allergy is headquartered in Leiden, where all disciplines work under one roof, from development to sales. We work in an informal, culturally diverse organization with room for growth and continued personal development. HAL Allergy is located in the middle of the thriving and energetic Leiden Bio Science Park, the largest innovation district of the Netherlands in the field of Life Sciences & Health. The central train station and the ancient city center of Leiden are just a 5 minute bike ride away from our office.
