Head of Quality
Department: Quality
Employment Type: Permanent - Full Time
Location: invoX Remote (UK)
Reporting To: Joe Neale
Description
The invoX Belgium NV, Respiratory Innovation Centre is focused on the development of pharmaceutical products with superior delivery to the lung using the differentiated technology in our next generation Soft Mist Inhalation (SMI) device. Our proprietary, propellant-free, purely mechanical device delivers medication to the lungs more effectively than other types of inhalers and is poised to change the treatment paradigm in large markets including asthma and COPD.
To help continue our growth and success, we are looking for a Head of Quality. This position will be focused on overseeing and ensuring the highest standards of quality for our next generation Soft Mist Inhalation (SMI) device. As invoX continues to grow, this is a compelling opportunity to work in a fast-paced business.
invoX is a research-driven global biopharmaceutical company using next-generation technology platforms to discover and develop innovative medicines that can change the lives of people around the world. Our vision is to be a leading global biopharmaceutical company with an advancing pipeline of products addressing the unmet healthcare needs of patients. invoX is a wholly owned subsidiary of Sino Biopharmaceutical Limited, a Hong Kong listed global top 40 pharmaceutical company with more than 24,000 employees.
Key Responsibilities
The purpose of the Head of Quality role is to ensure that our next generation Soft Mist Inhalation (SMI) device meets the highest standards of quality and regulatory compliance, ultimately enhancing patient outcomes and revolutionizing respiratory treatment. This will be achieved by leading and mentoring the quality team, implementing a robust fit for purpose quality management system, establishing a quality culture across the organisation and driving continuous improvement activities. This position is crucial for maintaining the integrity of our products, fostering customer trust, and supporting the company’s growth and success in delivering life-changing therapies to those in need.
You will:
* Develop and implement the quality strategy for the evolution of our QMS, drive its implementation and ensure its continuous improvement.
* Ensure compliance with all relevant regulatory standards and guidelines.
* Ensure proper documentation and record-keeping in line with regulatory requirements.
* Address and resolve any quality-related issues or non-conformances.
* Establish and maintain quality metrics and performance indicators.
* Lead quality audits and inspections from regulatory bodies and clients.
* Develop and implement a quality plan for the delivery of our next generation Soft Mist Inhalation (SMI) device to market.
* Develop and implement a strategy for establishing a quality culture through the organisation and ensure the relevant education and training is provided.
* Manage and mentor the quality team, fostering a culture of excellence and continuous improvement.
* Collaborate with cross-functional teams to support product development and manufacturing processes.
* Stay current with industry trends, regulatory changes, and best practices in quality management.
Skills, Knowledge & Expertise
You will have significant experience in quality management within medical device industry, ideally with drug/device combination products. Extensive experience with regulatory audits, GMP, and ISO standards is essential, along with a proven track record of successfully leading quality teams.
Strong analytical and problem-solving skills, excellent communication and leadership abilities, and proficiency in quality management systems are crucial. Additionally, the candidate should be detail-oriented, capable of managing multiple projects in a fast-paced environment and committed to continuous improvement and compliance with all regulatory requirements.
Essential
* Extensive experience in quality management within the medical device industry.
* Proven track record of successfully leading quality teams.
* Demonstrated ISO13485 and 21CFR820 compliance implementation.
* In-depth knowledge of regulatory requirements for drug/device combination products.
* Detail-oriented with a focus on continuous improvement, strong analytical and problem-solving skills.
* Excellent communication and leadership abilities.
* Ability to work effectively in a fast-paced, dynamic environment.
* Experience with quality management systems and tools.
* Experience with regulatory audits and inspections.
* Strong understanding of GMP
* Excellent organizational and project management skills.
* Bachelor's degree in a relevant field (e.g., Quality Management, Pharmaceutical Sciences, Engineering).
Desirable
* Advanced degree in a related field.
* Experience in Respiratory
* Experience with Soft Mist Inhalation (SMI) devices.
* Knowledge of statistical process control (SPC) and Six Sigma methodologies.
* Proficiency in multiple languages.
* Experience in a global or multi-site environment.
Job Benefits
We get things done, we keep things simple and we are driven by the science. We are ambitious so we work hard to create an environment where we can take smart risks. We want to be innovative so encourage debate and collaboration to challenge the usual way of doing things. We love our celebrations and socialising, which make invoX a fun and diverse place to work. And most of all, everyone has the opportunity to make a difference.
For this position candidates must be eligible to live and work in the UK or EU, and be based in either the UK or Belgium. Regardless of location, you will be required to spend some time at our offices in Diepenbeek, Belgium
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