Summary
Overview
Work history
Education
Skills
References
Timeline
Generic

Nicola Mackenzie

Lancaster,Lancashire

Summary

In my 38 years at University Hospitals of Morecambe Bay NHS Trust (UHMBT), I have consistently demonstrated strong leadership in Quality Assurance and Governance. As a key member of the R&D Senior Management Team, I have successfully led the management and oversight of the Trust’s Quality Management System (QMS) and Quality Assurance (QA) processes. My role has involved not only ensuring compliance with critical regulations but also driving continuous improvement initiatives that enhance the quality and efficiency of research activities. I take pride in my ability to inspire and guide teams, fostering a culture of excellence and accountability.

I firmly believe that diversity is a powerful asset in any organisation. Throughout my career, I have actively endorsed the value of diverse perspectives and experiences within my teams. I have implemented practices that ensure every team member feels valued and empowered to contribute their unique insights. By promoting an inclusive environment, I have witnessed firsthand how diverse teams drive innovation and achieve exceptional outcomes. I am committed to continuing this philosophy in my next role, ensuring that all employees are given equal opportunities to excel and progress.

While I have greatly enjoyed my time at UHMBT, I have also recognised the challenges posed by financial constraints that have impacted our ability to maintain a healthy work-life balance for staff. This realisation has motivated me to seek new opportunities where I can leverage my skills to make a meaningful impact. I view these challenges as opportunities for growth and transformation, and I am eager to bring my experience in managing quality assurance and governance to a new organisation that prioritises employee well-being and development.

Having researched your organisation, I am impressed by your commitment to quality, inclusivity, and excellence. I resonate deeply with these values and believe that my extensive experience in quality assurance aligns perfectly with your mission. I am particularly drawn to your focus on fostering a supportive environment where employees can thrive. I am excited about the prospect of contributing to your organisation’s goals while ensuring that all research activities are conducted to the highest ethical and regulatory standards.

I am highly motivated to embrace new challenges and continue my professional development in a supportive environment. I am eager to learn from my colleagues and contribute my expertise to enhance the quality and effectiveness of research initiatives. I believe that by joining your team, I can not only share my knowledge and experience but also grow alongside the organisation, adapting to new challenges and opportunities as they arise.

Overview

39
39
years of professional experience
4
4
years of post-secondary education

Work history

Clincal Research Governances & Admin Manager

University Hospitals of Morecambe Bay NHS Foundation Trust
Lancaster, Lancashire
07.1987 - Current
  • Managed Research Governance and Administration Teams, optimising workloads and fostering staff development.
  • Oversaw approval processes for Trust-hosted research studies, ensuring compliance with regulations.
  • Collaborated on strategic priorities within the R&D Senior Management Team, implementing governance initiatives.
  • Implemented risk management frameworks to support safe research delivery across the department.
  • Maintained up-to-date knowledge of industry trends and regulations, facilitating informed decision-making.
  • Streamlined operational processes to enhance productivity while maintaining quality standards.
  • Conducted regular audits to ensure adherence to regulatory compliance and identified areas for improvement.
  • Managed conflict resolution among team members to foster a harmonious work environment.
  • Undertook project management duties, ensuring timely completion within budget constraints.
  • Liaised with external vendors, negotiating favourable terms of service contracts.
  • Oversaw recruitment processes to attract high-quality candidates.
  • Developed comprehensive quality control procedures to ensure optimal product manufacture.
  • Collaborated with other department heads to improve overall company operations and efficiency.
  • Reviewed production processes, identifying areas for improvement.
  • Initiated timely corrective actions whenever defects were identified during audits.
  • Engaged in continuous professional development activities, enhancing personal skills and knowledge base in the field.
  • Implemented preventive measures to reduce incidents of non-conformance with set standards.
  • Provided administrative support to manage annual review processes for programmes.
  • Adhered to compliance and business timetables to meet set deadlines.
  • Performed periodic operational checks of data held within the database to uphold quality standards.
  • Assisted with drafting, reviewing, and finalising Standard Operating Procedures and Work Instructions.
  • Collated required documentation to support external reviews and audits.
  • Attended meetings and submitted decisions made to senior management for approval.
  • Mitigated potential risks by implementing proactive strategies to address key issues.
  • Contributed to the development of guidelines, processes, and documentation to meet required business standards.
  • Assessed data to meet contractual obligations and identify missing or incomplete information.
  • Followed up on allocated action plans to meet completion timescales.
  • Established plans governing production policies, daily operations, and long-term planning.
  • Negotiated rates with suppliers and managed relationships to maintain adequate levels of quality.
  • Prepared timelines for the delivery of research development projects to manage stakeholder expectations.
  • Led the recruitment of manufacturing staff members, overseeing the selection, training, and performance of new employees.
  • Provided quotations for the manufacture of specialised goods and products, establishing contracts with customers.
  • Set clear budget targets and established successful controls to manage expenditure.

Education

B/TEC National Diploma in Bussiness - Business

Lancaster and Morecambe College of Further Education
Lancaster, Lancashire
09.1983 - 04.1987

Skills

    Quality Assurance and Compliance
  • Managed oversight of the Trust’s Quality Management System (QMS) and Quality Assurance (QA) processes in R&D to ensure compliance with regulations
  • Oversaw approval processes for Trust-hosted research studies while ensuring ongoing compliance
  • Conducted regular audits to ensure regulatory compliance
  • Developed comprehensive quality control procedures ensuring optimal product manufacture
  • Implemented risk management frameworks supporting safe and effective research delivery across the department
  • Maintained up-to-date knowledge of industry trends and regulations, aiding in informed decision-making processes
  • Implemented preventive measures reducing incidents of nonconformance with set standards
  • Reviewed production processes, identifying areas for improvement
  • Maintained up-to-date procedures for complaints and compliance
  • Implemented and maintained complaints and compliance action tracker to improve production standards
  • Handled and oversaw logistics for visits by external review bodies
  • Analysed data from external sources to identify potential product and service issues
  • Regulatory compliance (This item is a general statement and could be considered redundant if the specific compliance items are already listed)
  • Team Leadership and Development
  • Directed Research Governance and Administration Teams, managing workloads and fostering staff development
  • Engaged in continuous professional development activities enhancing personal skills and knowledge base in the field
  • Managed conflict resolution amongst team members, fostering a harmonious work environment
  • Oversaw employee performance to monitor and enforce compliance with company standards
  • Staff supervision and development (This is similar to managing workloads and fostering staff development)
  • Training and development (This could overlap with staff development)
  • Interpersonal communication
  • Leadership skills
  • Team leadership (This could overlap with directing teams)
  • Operational Management
  • Collaborated on strategic priorities within R&D Senior Management Team to implement governance initiatives
  • Streamlined operational processes to enhance productivity without compromising quality
  • Optimised use of resources for cost-effective operations whilst maintaining high-quality output
  • Mitigated potential risks by carrying out thorough risk assessments regularly
  • Provided administrative support to manage annual review processes for programmes
  • Performed periodic operational checks of data held within the database to uphold quality standards
  • Developed operational strategies
  • Process improvements (This could overlap with streamlining operational processes)
  • Process optimisation tools
  • Time efficiency
  • Logistical planning
  • Operational support
  • Communication and Relationship Management
  • Compiling reports
  • Business correspondence
  • Customer relationship management usage
  • Interdepartmental communication
  • Scheduling and diary management
  • Outstanding customer service
  • Client account management
  • Public relations strategies
  • Communication proficiency
  • Cultural awareness
  • Intercultural competence
  • Financial Management
  • Basic accounting
  • Budgeting expertise
  • Budgeting and financial analysis
  • Invoicing and billing
  • Financial reporting
  • Contract negotiation and administration
  • Procurement procedures
  • Contract management
  • Project and Event Management
  • Project management
  • Event coordination
  • Proposal writing
  • Audit preparation
  • Vendor negotiation
  • Quality and Safety Assurance
  • Quality assurance
  • Health and safety compliance
  • Safety consciousness
  • Critical evaluation
  • Resilience under pressure
  • Initiative taking
  • Resourcefulness

References

References available upon request.

Timeline

Clincal Research Governances & Admin Manager

University Hospitals of Morecambe Bay NHS Foundation Trust
07.1987 - Current

B/TEC National Diploma in Bussiness - Business

Lancaster and Morecambe College of Further Education
09.1983 - 04.1987
Nicola Mackenzie