Founded in 2012, EyeD Pharma is a pharmaceutical company dedicated to the development of innovative drug products in ophthalmology. EyeD Pharma is developing innovative products based on a new delivery pathway of well-known drugs with the aim of improving quality of life of patients in various ocular pathologies.
In 2019, UniD Manufacturing was born, which brings together production activities. In parallel with its R&D and industrialization activities, EyeD Pharma started in 2017 a commercial activity of medical devices (equipment and consumables) for eye surgery.
EyeD Pharma and UniD Manufacturing headquarters are located in the Science Park of Liège. This collaborative environment will allow a positive synergy between R&D activities, production, logistics and administration.
To support its development, EyeD Pharma is hiring a Product Design Office Manager.
Main objectives of the function
Accountable for the design & development of EyeD Pharma products portfolio in accordance with regulatory requirements, quality standards, timelines, and budget. Perform managerial functions of moderate to significant scope with a high level of independence.
Main missions of this function
- Translate EyeD Pharma strategic goals into operational goals for the Product Design Office.
- Ensure the safety, low risk profile, reliability, ergonomics, and cost targets of products developed by Eyed Pharma.
- Ensure that User’s Needs, Voice of Customer, and Voice of Business are properly translated into product requirements.
- Provide technical expertise in the areas of design inputs definition, planning and execution of studies required to establish design outputs, and verification & validation strategy.
- Ensure that the product developed, as specified by its outputs, meets user’s needs and requirements.
- Ensure that product risk management activities are performed according to quality system and appropriate standards.
- Ensure that Human Factor & Usability Engineering studies are performed according to quality system and appropriate standards.
- Have a global oversight of pharmaceutical and medical device development activities, including the work of third parties.
- Drive effective collaboration with internal and external partners.
- Report progress to management, other departments, and partners.
- Ensure proper documentation of department activities according to quality management system.
- Ensure critical data review and compliance with GxP and standards requirements for all operations.
- Drive and lead the team to proactively identify project risks and mitigations.
- Ensure technical competency and expertise in the organization around: Quality by Design tools, risk management, safety and usability requirements, and reliability.
- Contribute to a continuous learning and process improvement environment.
- Hold team accountable for successful completion of projects/tasks.
- Provide leadership to team members, guiding them in terms of prioritization, problem resolution, process clarification, referrals to appropriate experts, etc
- Select, develop, and retain team members. Define and communicate criteria by which team and individual success will be measured. Provide constructive feedback and recognition.
- Ensure establishment and maintenance of procedures associated with Product Design Office activities.
- Professional background in a scientific discipline preferably in chemical or biomedical engineering, pharmaceutical sciences, or polymer chemistry
- Minimum of 5-7 years of relevant experience in R&D department of the pharmaceutical or medical device industry.
- Minimum of 3 years or significant experience in people management. Leadership of technical teams, and project management experience is desirable.
- Strong knowledge of the requirements of medicinal product, medical device, and/or combined product design & development (ICH Q8, ISO13485).
- Very good command in quality risk management (ICH Q9, ISO14971) and Usability Engineering (IEC62366).
- Experience in ophthalmic product development is a plus.
- Fluent in English and French.
- Strategic thinking, strong problem-solving and analytical skills.
- Effective administrator who efficiently manages time, resources, and workload.
- Strong written and verbal communication skills: display ability to communicate effectively using a wide variety of skills and vehicles and to various audiences including senior management.
- Must be able to challenge the status quo.
- Can comfortably handle risk and uncertainty; can decide and act without having the total picture.
- Act as an inspiring example for the other team members.
- Team player, Integrity, Caring
- Proactive and willing to work in a start-up environment.
EyeD Pharma offer
- A permanent position in an innovative and dynamic and fast growing company;
- Full time ;