CMC Manager

We are currently supporting a well‑established healthcare manufacturer undergoing a period of significant expansion across multiple sites. Due to a growing portfolio of CapEx projects and increased operational demand, the organisation is seeking an experienced Validation Officer to provide critical support to the validation function.

Having partnered with this business for over 15 years, we have a strong understanding of their culture and high expectations around quality, communication, and collaboration. This role provides the opportunity to contribute to a series of meaningful projects within a GMP‑regulated environment where natural health, nutraceutical and pharmaceutical products are all manufactured to pharmaceutical standards.

While this is an interim role, it represents an exciting opportunity to make a visible impact on key technical and site expansion initiatives.

 

Key Responsibilities:

• Leading the process to bring a previously outsourced filling line back in‑house, including full process reversal, tech transfer, and process development activities.
• Delivering validation activities across equipment, systems, and processes (IQ, OQ, PQ).
• Supporting equipment installation, upgrades, replacements, and expansions across the manufacturing facility.
• Contributing to multiple new and ongoing projects.

 

Experience & Requirements:

• Strong experience in process validation and the full validation lifecycle (IQ/OQ/PQ).
• Experience with tech transfer, equipment installation, and modifying existing systems.
• Demonstrated experience in GMP and pharmaceutical manufacturing.
• (Bonus) Experience in project management or supporting CapEx programmes.
• Ability to integrate quickly into a fast-paced team and adapt to evolving project needs.

 

Contract Details

• 3‑month contract (with opportunity for extension based on performance and project load).
• Ideally full-time (37.5 hours/week) or 4 days per week (30 hours).
• On-site in Wimbledon.
• Start date: ASAP (within 2-4 weeks preferred).

Change Lead – Learning Management System (LMS) Transformation (GxP)

We’re looking for a hands‑on Change Lead to drive the successful delivery and adoption of a new enterprise Learning Management System. In this role, you’ll turn the change strategy into practical, people‑centred activities across stakeholder engagement, communications, training readiness, and adoption support—ensuring the programme lands smoothly and delivers real business value.

You’ll work closely with Quality, Digital Enterprise Capabilities, project leadership, business stakeholders, and vendor partners to guide impacted teams through the transition and set the organisation up for long‑term success.

 

What you’ll do:

• Lead day‑to‑day change activities, aligned with key project milestones and go‑live readiness.
• Translate the change strategy into an integrated plan covering communications, engagement, learning, and adoption.
• Conduct impact and stakeholder analysis to identify risks, readiness needs, and mitigation actions.
• Build and manage stakeholder engagement plans and activate a change champion network.
• Create and deliver clear, engaging communications and end‑user materials.
• Support training planning, readiness, and learning-material quality.
• Track change actions, adoption indicators, risks, and resistance themes.
• Support governance, reporting, decision‑making, and transition to BAU.

 

What you bring:

• Experience in change management, within pharma GxP regulated environments.
• Strong communication and stakeholder management skills.
• Familiarity with GxP, IT compliance, data privacy, and validation requirements.
• Experience with LMS platforms (GxP LMS preferred).
• Ability to plan, coordinate, create content, and drive execution.
• Skilled with collaboration tools (Teams, Jira, Miro, etc.).
• Change‑management certifications (PROSCI, APMG, IOIC, etc.) are a plus.

 

Work environment:

• Fully remote, with occasional travel (Dublin/Cambridge/London).
• Some flexibility required for late‑day meetings with US West Coast stakeholders.

Job Title: Senior Clinical Research Associate (Sr. CRA)
Location: Remote (Eastern or Central Time Zone, U.S.)
Travel: ~50%

 

About the Role

We are seeking an experienced Senior Clinical Research Associate (Sr. CRA) to support clinical trials for an innovative cardiovascular medical device portfolio. This individual will play a critical role in ensuring the successful execution of clinical studies, maintaining compliance with regulatory requirements, and driving high-quality data collection across investigative sites.

 

Key Responsibilities

• Independently manage all aspects of site monitoring activities, including site qualification, initiation, routine monitoring, and close-out visits
• Oversee approximately 10 clinical trial sites, ensuring adherence to study protocols, GCP, and applicable regulatory requirements
• Build and maintain strong relationships with investigators and site staff to support enrollment, retention, and overall study success
• Perform source data verification (SDV) and ensure data integrity, accuracy, and completeness
• Identify, document, and resolve protocol deviations, data queries, and site performance issues
• Provide site training and ongoing support for study-related procedures and compliance expectations
• Collaborate cross-functionally with Clinical Operations, Data Management, Regulatory, and Medical Affairs teams
• Assist with site management responsibilities, including tracking site performance metrics and supporting risk mitigation strategies
• Contribute to study documentation, including monitoring reports, trip reports, and audit readiness activities

 

Qualifications

• Bachelor’s degree in life sciences, nursing, or related field
• 4+ years of clinical monitoring experience, with at least 1–2 years in a senior-level or lead CRA capacity
• Experience in cardiovascular studies and/or medical device trials strongly preferred
• Strong knowledge of ICH-GCP guidelines, FDA regulations, and clinical trial processes
• Proven ability to manage multiple sites and prioritize workload effectively
• Excellent communication, organizational, and problem-solving skills
• Ability to travel up to 50% as required

 

Preferred Qualifications

• Experience with complex interventional cardiovascular device trials (e.g., structural heart, electrophysiology, or vascular interventions)
• Prior involvement in site management or mentoring junior CRAs
• Experience working in a fast-paced, growth-stage company environment

 

What We Offer

• Competitive salary and performance-based incentives
• Comprehensive benefits package (medical, dental, vision, 401k, etc.)
• Opportunity to work on cutting-edge cardiovascular technologies that improve patient outcomes
• Collaborative, mission-driven culture with strong growth potential

 

Equal Opportunity Employer

We are committed to building a diverse and inclusive workplace and welcome applicants from all backgrounds.

 

If you’re a driven CRA looking to take the next step in your career and make a meaningful impact in cardiovascular innovation, we encourage you to apply.

Role

• Develop strategies addressing both biologic/drug and device components and align with company goals and regulatory expectations.
• Comprehend regulations, regulatory standards, directives, guidelines and advise Development, Technical Operations, and Quality teams on their applicability to and impact on product development projects.
• Lead plans and protocols for compatibility, design verification and functional stability studies, as well as  contribute to the design of human factor studies and usability testing.
• Provide strategic input to Design Control processes and documentation, ensuring alignment with health authorities and notified body requirements and global technical standards. Review DHF documentation from a regulatory perspective.
• Design and execute submission strategies for device-related dossier components (INDs/CTAs, marketing applications, and post-approval changes) in collaboration with company SMEs.
• Conduct research for the development of state-of-the-art studies.
• Operating effectively in a matrixed environment, influence cross-functional decision-making without direct authority.
• Assess change controls to identify and mitigate any regulatory risks.
• Lead health authorities and notified body interactions.
• Oversee device-related regulatory information in company systems.
• Support other Regulatory CMC activities.

 

Requirements

• Experience as the regulatory lead for combination products in pharmaceutical, biotechnology, or medical device industry setting.
• Prior and proven experience in late stage development of combination products.
• In-depth and broad experience with regulations, standards, directives, guidelines and requirements related to the use of combination products in global clinical trials and commercial registration.
• Strong understanding of ISO and ASTM standards relevant to combination products.
• Up to date with current industry trends and regulatory expectations associated with combination products.
• Good knowledge of ICH guidelines and GMP requirements for the development and manufacturing of biologics.
• A successful candidate will have strong communication skills, strategic acumen, collaboration, and influencing attributes.
• A bachelor's degree preferably in a scientific/engineering discipline

Location: Belgium / UK / Germany

 

I’m supporting a major biopharmaceutical company that is building out its Quantitative Clinical Pharmacology capability and looking for an experienced Pharmacometrics & AI/ML Lead. This is a strategic role for someone eager to push the boundaries of model‑informed and machine‑learning driven drug development. This position is perfect for someone who thrives at the intersection of advanced pharmacometrics, AI/ML innovation and clinical strategy. You will lead the vision and execution of AI‑enabled modelling approaches across the organisation’s development portfolio.

 

Key Responsibilities

In this role, you will drive and deliver:

• A robust AI/ML and Pharmacometrics strategy to guide dose optimisation, extrapolation, study design and regulatory planning.
• Application and evaluation of emerging technologies relevant to quantitative clinical pharmacology.
• Hands‑on delivery of AI/ML models, population PK/PD analyses, exposure–response modelling, and clinical trial simulations.
• High‑quality documentation including regulatory‑ready analysis plans and reports.
• Management of external vendors and the opportunity to internalise and grow AI/ML and PMx capabilities.
• Scientific and technical development of team members in modern PMx and AI‑driven modelling approaches.
• Engagement with global regulatory agencies, including contribution to discussions across therapy areas.
• Close collaboration with project leads to ensure seamless integration of modelling outputs.

 

We are looking for candidates with:

• PhD or MD in pharmaceutical sciences, engineering, statistics or a related field.
• 5+ years of industry experience in pharmacometrics, including significant hands-on AI/ML application in drug development.
• Strong background in population PK/PD, disease progression modelling, and simulation-based decision support.
• Technical skills in R, Python, Matlab, NONMEM or equivalent PMx software environments.

Overview:

We’re supporting a pharmaceutical manufacturing site operating in a 24/7 API / chemical processing environment. They are looking for a hands-on engineering leader to take ownership of facilities, utilities, and maintenance operations, ensuring continuous and reliable plant performance.
This is a key role focused on keeping the plant running, troubleshooting issues, and driving improvements across site infrastructure.

 

Key Responsibilities:

• Lead facilities and maintenance operations across a 24/7 manufacturing site
• Ensure reliability of critical plant utilities (e.g. HVAC, steam, water systems, compressed air, wastewater / effluent treatment)
• Act as a hands-on problem solver, supporting breakdowns and technical issues
• Drive preventive and predictive maintenance strategies to minimise downtime
• Oversee and interpret P&IDs to support troubleshooting and system improvements
• Manage and develop maintenance teams and external contractors
• Ensure site infrastructure operates in line with GMP and regulatory standards
• Support continuous improvement initiatives across plant operations

 

What They’re Looking For:

• Engineering background (Mechanical preferred)
• Strong experience in maintenance, facilities, or utilities within:
  • Pharmaceutical (API)
  • Chemical / process manufacturing
• Proven experience working in 24/7 continuous operations
• Hands-on experience with:
  • Plant utilities systems
  • Wastewater / effluent treatment (ETP/STP)
• P&IDs and process systems
• A practical, problem-solving mindset — someone who can get involved on the ground