To lead the effective management of core quality processes and support activities for a range of biological products in the Quality Assurance Department ensuring all goods manufactured and services provided by the Company meet cGMP and quality requirements of the Company, customers, and regulatory authorities. Leading the team who provide ongoing support to QMS processes within highly dynamic manufacturing operations, ensuring continuous improvement, quality culture training and execution of the processes to required standard within facility.
- Lead and ensure compliance of the Deviation process, including categorisation and approval of deviations, Ensuring compliance with cGMP, quality, and regulatory standard requirements. Support other functions in identifying corrective and preventive actions, root cause determination, complete failure investigations, and follow up to corrective and preventive actions, ensuring adequate and timely closure, and escalations significant events as appropriate, leading the triage meetings for significant issues.
- Create and enhance collaborative and trusting relationships with manufacturing team and establish effective communication.
- Participate in the development, maintenance, and improvement of the deviation and risk management processes to meet the requirements of the relevant regulatory authorities, Notified Bodies (if applicable) and all other applicable quality and regulatory standards.
- Management and oversight of the Batch review and release process working cross functionally with other site functions. Tracking outstanding actions to meet targeted release dates, escalating risks to senior management.
- Ensure that KPIs are maintained and lead action plan improvements when necessary, supporting other departments in effective decision-making processes.
- Ensure execution of the Quality oversight on the shop floor schedule inclusive of Production, warehouse, QC, and engineering areas. Ensure relationships between The Quality department and all other operational departments are built and maintained.
- Line management of Quality Officers and Quality Administrators as applicable, responsibility for performance and development of direct reports. Ensure that departmental objectives are implemented in line with the overall Quality /Corporate goals. Influence change and lead continuous improvement projects, identify improvements, and lead projects for cost saving and time saving initiatives.
Skills and Attributes
- Degree in science discipline, chemistry, biology, or medical technology preferred. (Or demonstration of satisfactory experience within a pharmaceutical manufacturing environment)
- Recognised Quality qualification, e.g., CQI Diploma in Quality (or demonstration of satisfactory experience within QA department) or demonstrated adequate experience in the similar role.
- Experience in a drug manufacturing within GMP environment or biologics industry in Quality Assurance, Quality Control or Quality Engineering position.
- Demonstrated knowledge of document control systems.
- Experience with internal and external audit processes.
- Demonstrated knowledge of cGMPs, Notified Body, MHRA, FDA regulations and SOPs.
- Demonstrated advanced computer skills – Microsoft Office preferred.
- Ability to effectively lead the team, provide constructive feedback and influence other people.
- Excellent verbal, written and interpersonal skills, including the ability to conduct verbal presentations appropriate to the level of the audience.
- Highly driven individual who is organised and able to meet defined targets.
- The ability to think strategically and influence at a senior level.
- Demonstrated success working in a team environment.
- Dynamic Quality professional and diligent in all matters of compliance.
- 25 annual leave days plus bank holidays and 3 annual company closure days (to be taken between Christmas and New year)
- Competitive Pension Scheme
- Private Medical Insurance
- Discretionary Bonus Plan
- Paid Maternity and Paternity Leave
- Academic Study Assistance
- Eyecare vouchers
- Employee Assistance Programme
Applications are encouraged from all sections of the community.