Program Lead

Hyper Recruitment Solutions; Wallonië; On-site; EUR 170,000 - 185,000; Full time

Job summary

Hyper Recruitment Solutions Ltd is recruiting a Program Lead - Drug Delivery to join a leading Pharmaceutical company in the Walloon Region, Belgium. You will lead drug delivery system design, development, industrialisation and lifecycle management, ensuring regulatory compliance and manufacturing readiness.

The role reports to the head of device programme leadership and is a senior freelance appointment, initially until October 2027, with a daily rate of €920-€1000.

Qualifications

• As a minimum, a scientific or engineering degree or equivalent
• Extensive drug delivery systems experience and capability to lead technical programs
• Knowledge of ISO 13485, 21 CFR 820 and related device regulations

Responsibilities

• Lead drug delivery system design, development, industrialisation and maintenance
• Coordinate cross-functional interfaces and start design control activities
• Manage programme planning, budgets and resources across teams
• Drive lifecycle management, risk assessment and post-market activities

Skills

Drug delivery systems

Project management

Cross-functional leadership

Planning and budgeting

Communication skills

Education

Science/Engineering degree

Tools

ISO 13485 knowledge

Regulatory affairs experience

Job description

We are actively recruiting a Program Lead - Drug Delivery to join a leading Pharmaceutical company in the Walloon Region, Belgium. As the Program Lead - Drug Delivery you will be responsible for bringing drug delivery systems from early design and new product introduction through industrialisation, commercial launch and ongoing lifecycle management.

This is an opportunity to shape the technical direction and delivery of device programmes, connecting development decisions with manufacturing readiness and regulatory compliance. As a Program Lead - Drug Delivery, you will work across device development, manufacturing, quality assurance and regulatory affairs, alongside external partners, to turn programme objectives into practical results.

Reporting to the head of device programme leadership, you will lead one or more programmes while also contributing specialist expertise to others.

This is a senior Freelance appointment, the mission is initially until October 2027, and the budget is €920-€1000 per day.

KEY DUTIES AND RESPONSIBILITIES:

Your duties as the Device Program Lead will be varied however the key duties and responsibilities are as follows:

• 1. As a Program Lead - Drug Delivery, you will lead drug delivery system design, development, industrialisation and maintenance. You will assess new devices and technologies, translate stakeholder needs into realistic product requirements, and coordinate early development handovers into formal design control activities.
• 2. As a Program Lead - Drug Delivery, you will own programme planning, budgets and resources, aligning cross-functional and matrix teams around delivery priorities. You will manage internal and external interfaces, support negotiations on industrialisation contracts and supplier agreements, and ensure intellectual property arising from programme activities is appropriately protected.
• 3. As a Program Lead - Drug Delivery, you will coordinate design verification, design validation, process validation and commercial launch readiness, contributing to regulatory submissions and maintaining the Design History File. You will ensure activities meet the medical device quality management system and applicable quality, safety, efficacy and good manufacturing practice requirements for drug-device combination products.
• 4. As a Program Lead - Drug Delivery, you will drive lifecycle management and on-market technical support, addressing market feedback, technical documentation, post-market obligations and further regulatory submissions. You will assess risks, lead issue resolution and corrective and preventive actions, and coach colleagues in practical problem-solving and continuous improvement.

ROLE REQUIREMENTS:

To be successful in your application to this exciting opportunity as the Program Lead - Drug Delivery we are looking to identify the following on your profile and past history:

• 1. Relevant degree in a scientific or engineering discipline, or equivalent technical expertise developed with combination / drug delivery products. Green Belt and/or project management certification would be advantageous.
• 2. Extensive industry experience with drug delivery systems, with the ability to lead technical programmes and influence cross functional teams. You will bring planning, negotiation and communication skills, independent judgement and a constructive approach to coaching, feedback and resolving delivery challenges.
• 3. A working knowledge and practical experience with ISO 13485, 21 CFR 820, 21 CFR 210/211, 21 CFR 4, ISO 14971, ICH Q9 and Medical Device Regulation requirements. Your background should support evidence-based decisions, effective risk management and compliant device development throughout the product lifecycle.

Key Words: Device Program Lead / Device Programme Manager / Drug Delivery Systems / Combination Products / Medical Device Development / Design Control / Industrialisation / Lifecycle Management / Design Verification / Medical Device Quality / Device Program Lead / Drug Delivery / Industrialization / Packaging

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the Life Science sectors, combining recruitment expertise with scientific knowledge to help you advance your career.