Experienced Manager with over 11 years in Pharmaceutical industry. Excellent reputation for resolving problems and improving customer satisfaction. Offers flexible schedule to deliver on team goals.
Overview
13
13
years of professional experience
5
5
years of post-secondary education
Work history
General Manager
Medicines Manufacturing Facility
12.2022 - 04.2025
Management of 3 Manufacturing sites with the purpose of manufacturing medicines for patient use for autoimmune conditions
Management of large teams 30-40+ including contractors having access to the facilities for maintenance
Working closely with the Assistant Director of Operations
Supervise and support Quality and Production and Service delivery managers to facilitate and ensure Good Manufacturing Practice services
Ensuring robust processes are set up and maintained.
Manage resource management throughout the business to ensure a timely delivery of services
Provide expert input across the Medical School in relation to the operation of the manufacturing business.
Execution and effectiveness of any strategic decisions relating to the business
Manage the Senior Management Team in the provision of training to personnel in line with legislation, national and local standards, and expectations.
In liaison with the management team and Clinical Research Compliance Team, ensure overall efficiency performance and quality of the business functions and services provided, and ensure dissemination of information to relevant parties are applicable.
Ensure any issues noted are dealt with appropriately. Support the Senior management Team in the promotion of the business to diverse network of academic, clinical and commercial customers, maintaining relationships and resolving high level client issues.
Manage the Production and Quality Managers in the maintenance of the existing Medical Health Regulation Agency and Human Tissue Authority licences on behalf of, and in close partnership with, the Designated Individual and Qualified Person.
Ensuring licences are fit for inspection by the Medical Health Regulation Agency/ Human Tissue Authority and compliant with the regulations and codes of practice.
Persons Designated on the Human Tissue Authority licence
Manage Quality Managers in preparation for, management of, and responses to any external audits and inspections, liaising with all relevant stakeholders as appropriate.
Active member of the Human Tissue Oversight Committee
Ensure emerging legislation, research, governance, ethical conduct, and good practice is appropriately embedded in the business through the Pharmaceutical Quality System
Facilitate the further development of the Quality System and contribute to its execution, ensuring fit for purpose
Input and review of quality check and audits within the company, contribute to resolution of any issues raised, leading to operation response.
Review and complete the appropriate contracts such as, Material Transfer Agreements, Service Level Agreements and Quality Technical Agreements
Identify areas of non-compliance
Oversee appropriate resolution by Corrective Action Preventative Actions. Develop and maintain systems to underpin financial oversight.
Budget planning costing for clients and cost recovery for the provision of services
Ensuring the facility and associated staffing structures remain effectively self-funded through their activities
Led cross-functional teams to enhance operational efficiency and streamline production processes.
Developed and implemented strategic initiatives to improve product quality and compliance with industry regulations.
Coordinated training programmes for staff to ensure adherence to safety protocols and best manufacturing practices.
Oversaw budget management and resource allocation to facilitate successful project execution and operational stability.
Fostered a culture of continuous improvement by encouraging employee feedback and implementing innovative solutions.
Managed relationships with suppliers and stakeholders to secure necessary materials and maintain supply chain integrity.
Analysed production metrics to identify trends and drive informed decision-making for future operational strategies.
Successfully negotiated contracts with suppliers to reduce costs.
Managed key stakeholder relationships for smoother project completion.
Oversaw all aspects of daily operations, ensuring smooth running of the organisation.
Established a positive work environment which promoted staff morale and productivity.
Streamlined communication processes for improved team collaboration.
Maintained compliance with industry regulations at all times.
Allocated resources to teams and projects based on need, performance and availability.
Worked with board of directors to establish objectives and decisively lead operations.
Established budgets based on historical, current and forecasted business data.
Quality Manager
Medicines Manufacturing Facility
12.2018 - 12.2022
Lead the validation and quality control of in-process investigations and release assays. Approving specifications, sampling instructions and test methods to monitor factors which may affect product quality, assess intermediate, bulk and finished product.
Proactive in ways to further to improve quality and compliance. Continually monitor and trend quality control parameters and implement improvements when required.
Report frequently reoccurring issues related to quality deviations, and quality standards and recommend ways of dealing with them.
Development and implementation of written policies, standard operating procedures, and quality-controlled documents, their ongoing review and revision.
Participate in internal audits, to include planning, performing, reporting of findings, making recommendations, and implementing improvements
Amendment of SOPs that are no longer fit for purpose by recommending, developing and implementing new, appropriately validated procedures.
Approval and monitoring of suppliers
Approval and rejection of materials and packaging materials
Designation and monitoring of storage conditions for materials and products.
Ensure facility, systems and equipment are validated
Ensure production/ batch records are signed by an Qualified person
Facilitating the development of new therapies by assisting with the translation of research protocols into clinical protocols, with a view for regulatory validation, and compliant to cGMP standards.
Pre-Final check of Final Product in readiness for QP release.
Approving and monitoring contracts with third parties and ensuring they are in line with the requirements of the MHRA, the HTA and any other relevant bodies with regards to quality.
Preparation of new, or renewal of existing, regulatory licence applications in regards to quality control
Preparation and close involvement during regulatory inspections e.g. MHRA, HTA, Health and Safety.
Developed and implemented quality management systems to ensure compliance with industry regulations.
Conducted regular audits and inspections to assess adherence to quality standards and identify areas for improvement.
Trained and mentored staff on quality assurance practices, fostering a culture of continuous improvement.
Collaborated with regulatory agencies during inspections to demonstrate compliance with quality assurance requirements.
Reviewed and approved documentation related to quality control processes, ensuring accuracy and completeness.
Ensured consistency in product quality with regular inspections and tests.
Managed audits of manufacturing operations, ensuring compliance with industry regulations.
Handled non-conformance issues proactively, reducing production delays significantly.
Led company-wide quality campaigns, fostering a culture of excellence and continuous improvement.
Ensured adherence to health and safety guidelines within the organisation protecting employee wellbeing.
Evaluated manufacturing processes regularly and documented analysis results for business improvement and growth.
GMP Production
Medicines Manufacturing Facility, Microbiome Treatment Centre
05.2018 - 12.2018
Material Receipt
Cleaning and Disinfection of a Non Sterile Grade D laboratory
Environmental Monitoring FMT Manufacture
Lead Analyst
Boots Contract Manufacturing
Nottingham
10.2017 - 02.2018
Company Overview: Nottingham
HPLC, GC Stability Testing and Maintenance
Working Review
Scrutiny of Chromatograms
Trained Trainer
SOP Reviewer and Amendments
Reference Standards testing
Nottingham
Quality Control Analyst
Boots Contract Manufacturing
Nottingham
10.2016 - 09.2017
Company Overview: Nottingham
Support Delivery of an efficient and compliant testing service to internal and external customers
Manage work priorities inline with deadlines
Performing a variety of routine chemical and physical tests of medicinal and healthcare products to Good Laboratory Working Practice
Maintaining consistency and focus everyday particularity on quality and compliance
Review test results ensuring any Out Of Specification are promptly escalated
Communicate and problems and delays to projects and escalate through appropriate routes
Support a positive culture of safety to ensure the laboratory meets all health and safety requirements
Routine Testing included, Karl Fisher, Titrations, GC, HPLC and Chromeleon, Dry Matter, Loss of Drying, UV Vis Spectroscopy, Limit Tests, FTIR, NIR, Viscosity, Density, TIN, ZINC
Preparation of Solutions
Calibration of Equipment
Monitoring of Equipment
Verified P&G scent test
Nottingham
Microbiologist
Mondelez International
Birmingham
09.2016 - 10.2016
Company Overview: Birmingham
Sample and Media Preparation
Testing for Salmonella, TVC, Yeast and Mould
Pathatrix and PCR
Documentation
Birmingham
Forensic Technician/ Toxicology
ESG Ltd: Toxicology Department
Burton on Trent
08.2014 - 09.2016
Company Overview: Burton on Trent
Sample receipt as per Chain of Custody Process
Immunoassay analysis Beckman Coulter
Troubleshooting of equipment
Confirmation of Drugs of Abuse using SPE, GCMS, and Head Space GCMS
Data Processing
Hair Analysis via UHPLC Shimadzu
Report Generation
Non Compliance
Customer Queries
Prioritising workload and working to strict deadlines as per court orders
Good documentation practice
Operation of Excel Spreadsheets for results, data entry into internal lims systems
Client Communication
Monitoring and Training new staff
Quality Assurance
Writing SOPs and amending if required on review.
Sharp attention to detail to ensure no mistakes are made delivery of high quality of work
Booking in appointments for Drugs & Alcohol testing
Uploading certification for Drugs & Alcohol testing
Issuing approved certification
Routine Proficiency Testing
Documenting all purchases made in the department via Purchase requisitions and excel
Stock take
Ordering
Client Confidentiality
Waste Management
Burton on Trent
Microbiology Department
Exova UK Ltd
Birmingham
12.2013 - 03.2014
Company Overview: Birmingham
Sample Sorting Job Numbers and LSN Numbers
Aseptic Filtration
Plating and Pouring
Labelling
Legionella, S&B, TVC (1,2 and 3 Day)
ECOLI and Coliforms, Pseudomonas, SRB, NRB, Yeast and Mould
Weighing
Preparation of media
Restock of materials
Cleaning and Disinfection
Birmingham
Analytical Chemistry Internship
Avans Hogeschool Breda
10.2012 - 03.2013
Company Overview: Netherlands
Trained in GC and HPLC
Fire Investigation Research
Thin Layer Chromatorgraphy
Fourier Transform Infrared
Polilight PL500
UV Vis Spectroscopy
Assistant Teaching
Laboratory preparation student classes
Netherlands
Education
International post graduate course - PCR principles and Parameters