Concept Life Sciences is a knowledge based, science led business focused on delivering the expertise and capabilities our clients demand. We work in the pharmaceutical, biotechnology, food, environmental, agrochemical, petrochemical, chemical and consumer products sectors. In order to deliver the science our clients demand, our business is focused on a number of core sectors. We support drug discovery and development in the pharmaceutical and biotechnology markets. We provide testing and specialist analytical services and consultancy to the food and environmental sectors. We provide toxicology services to the agrochemical, consumer products, chemical and pharmaceutical industries and materials chemistry services to the petrochemical industry.
This is an opportunity to join the Analytical and Development Services Division in the role of Quality Manager for the Groups UKAS ISO 17025 and GMP divisions
The successful candidate would be required to take the lead in ensuring that the demands of both customers and certifying bodies/ regulators are met and that a consistent approach to quality based processes is achieved.
Main Duties to:
- Lead the existing QA team across the company’s locations, at sites across the UK, to provide compliance oversight of GMP and ISO regulated activities.
- Fulfil the role of Group UKAS Quality Manager, in accordance with 17025 requirements.
- Work with the other Quality Managers within Concept Life Sciences to ensure a consistent approach to Quality is maintained across the company.
- Host Accreditation and Regulatory Inspections.
- Develop auditing strategies to ensure Concept Life Sciences meet the requirements of the regulations & accreditations held.
- Ensure that the systems and resources in place currently, and those that are developed, make efficient use of employees and are compliant with all regulatory and accreditation demands.
- Monitor the performance and develop your Quality Assurance (QA) team, and ensure that they have adequate training to complete their duties.
- Lead customer audits, where it is appropriate, to ensure the best possible outcome for the business in maintaining the customer’s confidence in the company’s services.
- Work with business development and operational staff to ensure that data quality and integrity is embedded into all the business does.
- Work in harmony with all employees to keep them engaged with the quality objectives of the company and foster effective communication between departments.
- Work with existing and developing systems to be able to report on quality related matters to the board in a timely manner.
- Remain current with compliance related developments and ensure that potential impacts are communicated to all relevant departments.
- Aid with the implementation of electronic Quality Management System (QMS).
- Assess problems pragmatically and assess risk and escalate as appropriate.
- Advise Management of any deficiencies in Accreditation or Regulatory requirements.
- A graduate with substantial experience in the testing and contract research/pharmaceutical industry working to ISO 17025, in a Quality Management role. Experience in a high throughput environment would be an advantage.
- Thorough knowledge, skills and abilities in managing ISO 17025, GMP Standards, guidance and regulations.
- Proven knowledge and experience of scheduling and performing audits.
- Experience in hosting/supporting customer, accreditation and regulatory agency inspections, in particular, understanding the requirements of UKAS.
- Excellent organisational, interpersonal and communication skills.
- Competent at preparing and delivering presentations to employees, customers and regulatory bodies.
- Strong management skills and ability to lead a team through change.
- Proven ability to challenge and drive quality and a compliant culture forward.
- Experience in influencing, impacting and leading QA operations through developing audit schedules, training initiatives, QA recruitment.
- Ability to investigate and review information and draw conclusions in support of CAPA, customer complaints etc.
- Travel throughout the UK will be required.
- Monday to Friday between 9:00am and 5:30pm. Flexibility is required, some weekend work may be needed and earlier or later start and finish times may also be required.
We offer a range of learning and development opportunities depending on the role, with all employees having access to a range of internally delivered training modules as standard. In our science based roles we offer structured career progression, more details of which can be discussed during the recruitment process. In addition to a competitive salary, we offer as a minimum: Pension scheme, Healthcare Cash Plan, Retail Discount scheme, Cycle to Work scheme, Childcare Vouchers, Discounted Gym membership rates and local Reward & Recognition schemes.