Site Name: Ireland - Dublin
Posted Date: Oct 30 2024
GSK create a place where people can grow, be their best, be safe, feel welcome, valued and included. We offer a competitive salary, annual bonus based on company performance, Healthcare & Wellbeing programmes, Pension Plan Membership, Shares and Savings programme.
GSK embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and office-based work.
407075 LOC QA Manager
QA Manager for the Commercial Local Operating Companies (LOC) to ensure that the mandated GSK Quality Management Systems requirements for operating units are met.
The function is critical to the effective management of systems and activities that are crucial or have a direct impact to product quality for the benefit of the patients and regulatory compliance, to ensure the licence to operate. QA Manager is expected to take the lead in implementing and sustaining the QMS in LOC Ireland, including encouraging the business to own quality activities in their day-to-day work. This position will strengthen the business partnership with supply chain, regulatory affairs, medical and commercial operations.
Job responsibilities (not limited to):
* Manage and co-ordinate day to day quality department activities including resource allocation, workflow, project priorities and department initiatives.
* Manage and develop quality personnel within LOC QA team.
* Responsible Person on the Wholesale Distribution Authorisation, ensuring the licence conditions, requirements of Good Distribution Practice (GDP) and Product authorizations are met.
* Approve any subcontracted activities which may impact on GDP.
* Ensure that a quality management system is implemented and maintained, focusing on the management of authorised activities and the accuracy and quality of records.
* Responsible for ensuring a robust, sustainable and effective QMS (Quality Management System) through monitoring and reviewing the compliance status within Ireland LOC.
* Ensure that all internal procedures and systems in use in the LOC are compliant to GSK QMS, and local regulatory requirements.
* Drive quality culture within the LOC building agility to respond to fast evolving environment, ensuring clear accountabilities and teamwork across local and global functions.
Why you?
Basic Qualifications & Skills:
* Pharmacy or Scientific Degree.
* Extensive experience within the Pharmaceutical / Consumer Healthcare industries in the capacity of a senior quality specialist or a manager.
* Strong understanding of and experience in quality assurance systems particularly in the areas of batch release, product incidents, quality oversight of logistics service provider.
* Able to effectively enable and drive change across cross functional stakeholders.
* Strong knowledge of regulatory requirements pertaining to GMP/GDP.
* Concise and persuasive in the description of the different QA situations. Able to stick to the standard and not be pressurised.
Preferred Qualifications & Skills:
* Right First Time execution.
* Flexible thinking – able to challenge and see views from different perspectives.
* Ability to self-motivate and be resilient and focused under pressure.
* Strong general computer literacy with Intermediate skills in Microsoft Word, Excel, Power Point and Outlook.
Closing Date for Applications: 22nd November 2024 (COB)
Please take a copy of the Job Description, as this will not be available post closure of the advert.
As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
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