We are looking for a Senior Project Manager to join a growing and innovative Specialty Diagnostics environment, supporting business transformation and change control initiatives. This role sits within a high-impact setting focused on delivering diagnostic solutions, where strong leadership and strategic direction are essential to achieving organisational goals and driving continuous improvement across functions.
Job Description
We are seeking a Quality Engineer to ensure quality compliance and support operations within a highly regulated environment. In this role, you will provide essential quality oversight through detailed documentation reviews, process monitoring, and close collaboration with cross-functional teams.
ou will directly contribute to delivering life-changing products by maintaining high standards, leading investigations, and driving continuous improvement initiatives
Responsibilities
- Compliance: Support and maintain strict compliance with GMP/GxP, ISO standards (9001/13485), and other international regulatory requirements.
- Investigations & CAPA: Investigate quality issues, lead root cause analysis efforts, and collaborate across teams to implement corrective and preventive actions.
- Process Management: Manage and support change control activities, deviations, and quality processes.
- Audits: Conduct, support, and lead internal and external audits as well as regulatory inspections.
- Documentation: Author, review, and update standard operating procedures (SOPs), investigation reports, and other quality documentation.
- Data & Analytics: Perform statistical analysis, data trending, and regular reporting of quality metrics.
- Continuous Improvement: Work with Quality Management Systems (e.g., MasterControl) to drive system enhancements and efficiency.
Requirements
- Bachelor's degree in Life Sciences, Engineering, Chemistry, Biology, or a related technical field with 5+ years of relevant quality assurance/control experience,
- OR Master's (or advanced) degree in a similar field with 3+ years of relevant experience.
- Industry Experience: Proven track record working within heavily regulated industries such as pharmaceuticals, biotechnology, or medical devices.
- System Knowledge: Practical experience with Quality Management Systems (QMS) like MasterControl or similar Document Control Systems.
- Core Competencies: Demonstrated expertise in CAPA processes, deviation management, change control, and root cause analysis techniques.
- Audit Experience: Direct experience with conducting or hosting internal/external audits and regulatory inspections.
- Nice-to-have: Project management experience and familiarity with risk assessment methodologies.
Benefits
- Location: REMOTE meetings attendance would be required- 1x month in Basingstoke
- Opportunity to lead high-impact transformation initiatives within a growing diagnostics organisation.
- Collaborative and innovative work environment.
- Opportunity for professional growth and long-term career development.
- Working hours: 40 hours per week, Monday to Friday
- Salary: £4670 per month ;
- Contract: Temporary for min 9 months - possibility of extension
- ref number: 27317
