Global Quality Lead (Assurance)

Global Quality Lead (Assurance) Location: Craigavon Hours: 37.5 hours per week Salary: Competitive Business Unit: Pharma Services Open To: Internal and External Applicants Ref No.: HRJOB10437 ? The Role The Global Quality Lead (Assurance) is responsible for developing and maintaining Global Quality Standards across all sites, ensuring compliance with global policies and procedures.
Apply (by clicking the relevant button) after checking through all the related job information below.
This role involves creating key performance indicators and process metrics to measure the performance(HD1) and effectiveness of the Pharmaceutical Quality System (PQS).
The Global Quality Lead monitors and reports on trends within the PQS, engaging with the business to address any issues promptly to maintain operational quality performance.
Additionally, the role supports continuous improvement by analysing data from key business areas and ensuring process compliance through training and governance.
The Global Quality Lead will be heavily involved in ownership of the PQS through development of the process, compliance with regulations, training and governance of the process.
This will also involve hosting forums (including preparing agendas, presentations and minute taking as required) with sites to promote discussions and aid consistency across sites, encouraging problem solving and continuous improvement.
Furthermore, the Global Quality Lead supports regulatory compliance, client audits, and regulatory inspections, leads process improvements, and develops training materials for global rollout.
? Key Requirements Have eligibility to work in the UK OR possess a valid work permit that will allow you to take up full time employment in the UK Degree level qualification (or equivalent) in a Life Science or technical discipline or related field OR significant experience in a similar technical role in lieu of a degree Significant experience working within an established Quality System within the Pharmaceutical Industry.
Significant experience working within the Quality compliance function with experience in multiple Quality Compliance aspects.
Significant experience with the generation, execution and review of quality compliance documents in pharmaceutical manufacturing and/or packaging facility eg change management, deviation/investigations, CAPA, product complaints.
Proven working knowledge of Pharmaceutical legislation and rules governing manufacture and distribution of products ? Desirable Requirements A degree in a Science/Business discipline Significant experience in conducting/supporting a Quality Risk Management process Previous experience in writing and producing detailed reports.
Lean Six Sigma/continuous improvement experience Experience of conducting Audits (Internal/External/Audit Qualification) Experience of project management/leading teams.
Previous experience of generating training material and the delivery of training.
? Further Information After a successful probation period the working pattern for this role is a flex pattern between the hours of 07:00 19:00 with core hours of 10:00 16:00.
This role will require coverage beyond normal working hours
– it is a condition of your employment that you are able to fulfil this requirement of the role.
? Apply Now Apply online and tailor your CV to outline how you meet the role criteria.
Please upload your CV in PDF format where possible.
? Closing Date We will no longer be accepting applications after 5pm on 25 February 2025 ? RECRUITMENT AGENCIES PLEASE NOTE: Almac will only accept applications from agencies/business partners that have been invited to work on this role by our Talent Acquisition team.
Speculative candidate CVs received or submitted directly to Hiring Managers will be considered unsolicited and no fee will be payable.
Thank you for your cooperation.
Skills: Quality Compliance quality systems Knowledge of GMP Benefits: Flexible Schedules Opportunities for Advancement Employee Referral Bonus Free onsite parking Group Healthcare Scheme