Head of Quality
£110000 - £130000 per annum
England

SciPro are partnered with a leading British healthcare company that brings together research, development, manufacture, marketing and distribution under one umbrella.

We are supporting them on their search for their next Head of Quality with a focus on leadership and support to Quality Managers across the Group.

Role Tasks:

Provide leadership and support to Quality Managers across the whole company.

Co-ordinate the development, implementation, monitoring and measurement of the QMS to satisfy relevant Company and regulatory requirements.

Identify and champion the harmonisation of key Quality systems and processes across the company to deliver efficient and robust processes.

Management Representative for the business. In conjunction with the Quality Managers, responsibility for planning all aspects of the Management Review process including scheduling meetings, setting the agenda and ensuring preparation and distribution of meeting minutes to Senior Management.

Work with cross-functional teams to effectively create and support process enhancement initiatives to create and maintain an environment of excellence and continuous improvement by acting as chair and facilitator for the Quality Assurance meetings.

Ensure self and Quality department are trained in all Health and Safety procedures and that all accidents are reported.

Skills / Knowledge /Experience:

Significant experience gained from working in a Pharmaceutical environment.

Many years in various management roles within QA.

Successful multi-disciplinary projects to deliver business benefit and/or QMS enhancements

Excellent interpersonal skills with the ability to work with and influence senior members of staff to ensure robust and reliable systems are in place.

Successful preparation and involvement with regulatory inspections/audits including MHRA and Medical Device Notified Bodies.

Apply
Other roles you might
be interested in:
Director of Clinical Quality
California, USA

A key client of ours in the CAR-T Cell Therapy space are looking for an experienced Director/Senior Director of Clinical Quality to join their team during an exciting growth phase! If you are passionate about making a difference in patients lives, and want to explore a new opportunity, look no further....   Responsibilities:   Apply advanced, international expertise in Good Clinical Practice (GCP) to develop, implement, and enhance cost-efficient, risk-focused quality assurance and compliance initiatives. Craft and execute a strategic roadmap for GCP/GLP Quality Assurance to harmonize with organizational goals. Establish and cultivate the GCP/GLP Quality Unit. Lead the establishment of a scalable, cost-effective, and risk-aligned quality assurance and compliance framework for overseeing clinical trials, ensuring site compliance, and monitoring safety. Provide quality oversight for international clinical trials, offering consultation to program/study teams and conducting risk assessments. Contribute to site activation, initiation, and qualification activities as necessary. Formulate and manage the GCP audit strategy and plan, collaborating with program/study teams and adhering to program timelines and objectives. Conduct evaluations of vendors and clinical sites as needed. Collaborate with cross-functional teams to address audit findings and implement corrective and preventive actions. Maintain and update the Corrective and Preventive Action (CAPA) process to ensure timely resolution of audit reports and actions. Serve as the primary liaison with regulatory agencies, leading GCP health authority audits and inspections. Implement an Inspection Readiness program and provide leadership for GCP inspection readiness training. Offer technical support during regulatory inspections of investigator sites and participate in regulatory agency inspections. Represent Quality Assurance (QA) in Program Teams, sub-teams, and study teams as required, providing guidance to ensure compliance with clinical protocols, GCP, and regulatory requirements. Strategize inspection readiness activities to support program/study teams. Develop and manage a robust quality management system to support clinical operations, including the development and implementation of policies, procedures, and processes aligned with industry standards and regulations. Continuously improve quality systems for efficiency and compliance. Lead investigations into significant quality issues related to GCP elements, product handling, administration, or safety. Facilitate root cause identification and develop appropriate corrective and preventive actions. Ensure reporting of potential or confirmed violations to regulatory authorities. Oversee the development, implementation, and maintenance of quality systems, processes, and procedures related to GCP/GLP and clinical trial oversight. Recruit, train, and mentor a high-performing team of quality assurance professionals. Foster collaboration with clinical development, regulatory affairs, clinical operations, patient operations, medical affairs, and other departments to ensure alignment in quality compliance activities. Provide guidance and support on quality-related matters. Stay abreast of GCP legislation and relevant guidelines, integrating updates into organizational processes supporting clinical development.   Requirements: Advanced degree in life sciences, pharmacy, or related field. Minimum of 10 years' experience in GCP/GLP compliance and monitoring in biotechnology or pharmaceuticals, preferably with a focus on autologous and allogeneic cell therapy treatments. Strong knowledge of FDA, EMA, and ICH regulations, particularly regarding cell and tissue studies. Proven experience in developing and implementing quality systems in a clinical setting. Demonstrated success in managing audits and inspections.

Senior Embedded Electronics Engineer
San Diego, CA, USA

Job Description: You will be responsible for designing, testing, and implementing innovative sensor solutions, ensuring they meet the highest standards of performance, reliability, and efficiency. Knowledge of ultra-low power system design is crucial for this role. Proficiency in PPG (Photoplethysmography), EEG (Electroencephalography), acoustics, and signal processing is preferred.   Key Responsibilities: Lead the design, development, and deployment of cutting-edge embedded sensor systems for medical devices and wearable technologies, ensuring regulatory compliance and safety. Collaborate with cross-functional teams to integrate sensor hardware and software solutions seamlessly into medical devices and wearable technologies. Create prototypes, conduct rigorous testing, and refine sensor systems for optimal performance and accuracy in medical devices and wearables. Provide technical leadership within the team, guiding junior engineers and mentoring them in sensor technology for medical devices and wearables. Stay updated with the latest advancements in sensor technology and identify opportunities for innovation in the medical device, wearable, and related fields. Ensure that developed sensor systems meet high-quality standards and perform reliably within the medical device and wearable technology environment. Maintain comprehensive documentation of designs, test procedures, and results, adhering to medical device and wearable technology regulatory requirements. Collaborate with other teams to ensure the integration of sensor systems into existing medical device products and wearable technology solutions.   Qualifications: Bachelor’s or Master’s degree in Electrical Engineering, Computer Engineering, or a related field. A minimum of 10 years of experience in systems and embedded sensor systems development, with a focus on medical devices and wearable technologies. Deep experience in systems architecture for embedded ultra-low power multi sensor systems. Proficiency in sensor technologies, including PPG, EEG, acoustics, and signal processing, within the medical and wearable technology context. Strong programming skills in C/C++, Python, or other relevant languages. Knowledge of Bluetooth technology is a plus. Experience developing medical equipment is a plus. Expertise in hardware and software integration for medical devices and wearable technologies. Knowledge and experience in ultra-low power system design. Excellent problem-solving skills and the ability to work on complex, interdisciplinary projects. Strong leadership and mentorship capabilities. Exceptional communication skills. Experience in developing wearables is a significant plus.

banner

Need more help? Reach out<br></br> to one of our team.

We are a trusted partner for every step from Discovery through to Development. So, no matter where you are in your journey, we're here to help you make a difference. We are a trusted partner for every step from Discovery through to Development. So, no matter where you are in your journey, we're here to help you make a difference.