We are looking for a Validation Manager who will be responsible for providing specialized validation support and oversight of external CMO’s, critical manufacturing suppliers and internal development.
The Validation Manager will work closely with the VP Manufacturing and within the company QMS, to agree and define documentation requirements. They will also carry out and/or oversee external CMO practical aspects of IQ, OQ, and PQ validation tasks and associated validation approach/documentation and processes.
Key Roles & Responsibilities
Reporting to the VP Quality and Regulatory Affairs, and performing a combination, but not necessarily all, of the following duties:
- Lead validation activities relating to QuantuMDx Q-POC (instrument) and Q-CAS-2 (cassette) and sample caddy products.
- Ensure all requirements are laid out in validation protocols that cover all aspects of our partners processes, performance and internal equipment.
- Achieve validation timescales and highlights potentially problematic processes and supports internal/external teams in resolving them.
- Establish and define, in-conjunction with CMO’s and internal resources, acceptance test requirements.
- Provide input to product validation requirements.
- Set key validation criteria and specifications.
- Manage and execute periodic validation reviews as required.
- Execute statistical analysis to support validation procedures.
- Lead supplier audits relating to validation topics.
- Evaluate validation impact of proposed equipment or facility improvements.
- Provide continuous improvement and streamlining of validation procedures.
- Maintains all validation documentation updates throughout the product life cycle i.e. i.e. FMEA, URS, SIA, Risk, HSE, Work Instructions etc.
- Establish site validation procedures/processes/templates.
- Perform and manage all work in a safe manner and in compliance with local procedures/ company standards and current health, safety and environment legislation.
- Team Management:
- Work closely with the Quality and Manufacturing teams to ensure that the QMS demonstrates compliance with requirements for all products across all relevant territories with respect to process and product validation
- Identify opportunities to share knowledge across company functions and disseminate information for example through formal training sessions for any other relevant company departments
- Process Development:
- Ability to understand and apply regulatory standards for the products being developed
- Research and interpret standards for In vitro diagnostic devices and keep abreast of changes in regulations and standards to ensure that QuantuMDx validation activities comply and continue to comply
- Participate in risk management to all aspects of product development including process risks and product risks. Able to apply sound judgment and act quickly to contain, address and mitigate any risks that occur
- Time Management:
- Ability to manage both self and others conflicting activities to deliver on time
Experience, knowledge and requirements
- A highly motivated, organized, proactive and enthusiastic individual with a proven ability to work and motivate with utmost tact and diplomacy.
- Experience of working with ISO 13485 is essential with direct experience working in the IVD industry an advantage.
- Experience of planning, undertaking and recording process and product validation is essential with experience of including multi-component assembly and injection molded parts an advantage.
- Outstanding teamwork and ability to interact with external and internal partners on fast-paced projects.
- Good sense of humour and ability to adapt to a changing environment as the Company matures and moves from the R&D stage into commercialisation.
- Ability to work full time within the UK without restriction.
To apply for this role please send a cover letter and CV to moc.xdmutnauq@tnemtiurcer.
The intent of this job description is to provide a representation and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description.
QuantuMDx Group is an exciting and highly innovative multinational company headquartered in the United Kingdom, with operations and partners in the United States, Asia, Europe and Africa.
The Company’s technology innovates the molecular diagnostic work-flow, enabling delivery of rapid actionable answers to complex clinical questions at a price point accessible to both high and low resource settings.
The Company’s flagship device is the Q-POC™, a simple-to-use, affordable, portable sample to answer molecular diagnostic device. With its laboratory quality testing and cost-effective disposable, Q-POC™ will bring the power of precision medicine to health professionals throughout the world, regardless of location or budget. Moreover, with its best in class multiplexing technology, it enables rapid detection of antimicrobial resistance and subsequent ‘right first-time prescribing’.
The company is developing further diagnostic platforms that may be used as standalone devices or integrated into diagnostic workflows. Products include the pathogen enricher CAPTURE-XT™.