Associate Director Quality
|Contact Name:||Laurentina Kennedy|
The Associate Director Quality will be responsible for performing key Quality tasks in respect of Company products and development projects. Work in the Quality Systems Group, within the Technical Operations department, which oversees, IT Validation projects as well as internal Quality Systems. Reports directly to the Executive Director Quality.
The Associate Director Quality will be responsible for monitoring and supporting the quality performance of contract vendors for GxP systems. Specific responsibility for providing compliance leadership and direction in computer system validation projects for GMP, GDP, GPvP and GCP areas. The Associate Director Quality receives assignments in the form of goals.
Lead and oversee a team that provides support activities for GxP IT projects which include, but are not limited to: the review and approval of Validation/Qualification Plans; Risk Assessments; User Requirement Specifications; Traceability Matrices; Test Scripts (IQ, OQ/PQ); Data Migration Protocol and Summary Reports; System Administration SOPs as well as IT system Deviations and Change controls
Lead Quality, process and business-related projects using project management and project execution tools to deliver the agreed project objectives on time and to budget
Agree on the Project charter with key stakeholders, including resource requirements and timelines.
Facilitate the gathering of business needs, use case and solution criteria as needed
Build authentic relationships, lead business meetings and audits of IT vendors in all applicable GxP areas and review associated agreements for data related elements
Ensure continuing compliance with in-house qualified systems in addition to designing, implementing and improving those systems in line with industry best practices and regulatory expectations.
Contribute to the management of the supplier approval program and to the maintenance of the external audit schedule with a specific responsibility for the management of IT vendors
Collaborate with all contract manufacturers, packagers and testing laboratories to resolve any data integrity related quality issues to support the supply of commercial and clinical material
Participate in due diligence activities associated with strategic partnerships or new company acquisitions as required
Contribute to the successful outcome of all regulatory inspections associated with company business both internally and at contract manufacturers, service providers, packagers and laboratories, as required
Maintain quality and regulatory compliance, to ensure that there are no significant regulatory agency citations associated with any company-specific GMP activities.
In this respect, it may be necessary to collaborate with the regulatory affairs department and liaise with regulatory agencies in the process of resolving GMP specific quality issues
Understand new regulations and guidelines, as they apply to the company business, and implement systems and procedures to incorporate these new regulations, if appropriate.
Roll out training as appropriate
Communicate, where appropriate, with the Corporate Compliance group, on areas of common interest.
Communicate, where appropriate, with all corporate personnel and contribute to the development of global systems and procedures, as required.
Contribute to the design and implementation of best practice quality improvement projects and programmes and company expansion programmes.
Contribute to the development of quality policies and procedures and participate in the internal audit programme, which serves to verify adherence to and compliance with the requirements set out in these controlled documents.
Contribute to the development of training as required for Data Integrity awareness and guidance on assessing Data integrity practices at CMOs and CLOs.
Advise on complex Risk Scenarios directly affecting our GxP systems via interactive meetings, workshops and cross-functional meetings with colleagues and be able to reference appropriate regulations and guidance as required.
A Degree or Masters level in a science discipline is required, with an excellent understanding of quality assurance.
Qualified person status is desirable.
Experience with computer system software validation projects in a variety of GxP areas is required.
A strong understanding of and experience in quality management is essential with a proven track record in people management and personal development.
At least 10 years’ experience gained in finished product pharmaceutical manufacturing including validation activities is required.
Knowledge of QA for Pharmacovigilance, clinical trial data collection and manufacturing operations is desirable.
Experience working with outsourced IT solutions is also desirable.
An excellent understanding of quality guidelines and regulatory requirements as they apply to the industry is required.
Customer orientated with excellent communication skills and the ability to apply pragmatic logic to problem-solving and issue resolution is also required.
For further information on this Associate Director Quality position please contact Laurentina Kennedy at The RFT Group on 01 2302400 / Laurentina@rftgroup.ie. Check out all our open jobs on our Recruitment website: www.rftgroup.ie
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