Clinical QA manager (Contract) Dublin
|Job Title:||Clinical QA manager (Contract) Dublin|
|Location:||Dublin, Republic of Ireland|
|Contact Name:||Nathan Wilson|
|Job Published:||July 26, 2017 19:02|
- Provide strategic Quality Assurance (QA) support at the Global Service Centre for Clinical Project Management (CPM) Clinical Team (CT), in the Scientific Services Practice within Product Lifecycle Services (PLS) and for respective medical services which fall under GxP.
- Closely collaborate with the PLS business partners to ensure GxP compliance and provide quality oversight for the respective service scope of the clinical trials (CT).
- Support the implementation of a risk based quality management process fully embedded into the clinical trial service delivery including all vendor managed business setups with the objective of achieving the highest data quality standards, full adherence to patient's rights and well-being and in support of successful Health Authority inspections.
- Provide operational QA support to the PLS clinical team, including quality oversight for Health Authority commitments, critical incidents including respective escalation process and the implementation of corrective & preventive actions (CAPAs) for the respective business areas.
- Act as QA contact to the customer QA organization in line with established quality agreements.
- Drive the implementation of the quality requirements within the PLS clinical team.
- Monitor and track implementation of the annual Quality Plan deliverables together with the supported CT including the quality risk assessments and inspection readiness components for the designated trials.
- Provide Quality input and oversight for the execution of clinical trials or respective services under the responsibility of PLS.
- Lead the quality requirement assessment for new services in close collaboration with the business teams.
- Lead the clinical part of the local Quality Review Board to ensure appropriate management review of all quality and compliance related topics including the review of key quality indicators (KQI); identify appropriate continuous improvement initiatives for quality and compliance related areas.
- Support strategic CT Quality and Business initiatives, including the design and implementation of respective quality and compliance activities and affected changes, the support of remediation programs and the development and implementation of strategic process improvement.
- Facilitate effective communications within the CT and by interacting with other QA functions and the customer QA in line with established quality agreements.
- Ensure that applicable PLS clinical processes are implemented in line with the service scope.
- Help to establish in-built controls in relevant process steps to ensure adherence to regulatory compliance.
- Monitor effectiveness of implementation of applicable clinical processes through KQIs in collaboration with business process owners to demonstrate that processes are in control and ensure required compliance levels.
- Implement and lead the process to regularly review and assess KQIs at the respective CTs. Ensure that potential gaps and risks are addressed and opportunities for continuous improvement identified.
- Ensure and provide effective Quality oversight and management.
- Adequate and timely escalation of incidents/issues within CTs and QA.
- Timely and effective initiation of investigations
- Definition of adequate CAPAs are defined, their implementation and effective closure tracked.
- Qualification and management of vendors for outsourced activities
- Provide quality oversight for Change Control
- Implementation of a self-assessment/self-inspection process.
- Implementation of adequate training within the respective CTs through respective tracking systems and effectiveness checks
- Facilitate respective regulatory inspection preparation, management and follow-up in collaboration with business functions.
- Support local inspections with adequate systems and process support.
- Support through open and effective communication and business partnering the cross-functional implementation of the Strategy, and Vision and Mission of PLS.
- Drive a culture of solution oriented and evidence based mind-set with openness for innovative ways of working and new technologies.
- Proactively contribute towards lessons learned information flow in the CTs based on read outs from audits, inspections, incidents, regulatory intelligence, effectiveness checks on process implementations and metrics.
- Degree in Life Sciences, Pharmacy or Medicines. Advanced degree a plus.
- At least 4 - 6 years of involvement in regulated activities, clinical development and QA positions; broad under-standing of global expectations of Health Authorities in the area of Clinical Development; profound understanding of the science of product development
- Ability to work independently and in a team environment.
- A minimum of 3 years experience in managing projects.
- Ability to effectively interact with and present to senior management at all levels, as well as to external audiences and inspectors.
- Strong skills in GCP, quality and/or clinical development.
- Strong interpersonal, communication, negotiation, and problem solving skills
- Strong project management skills desirable
Considerable organization awareness (e.g. interrelationship of departments, business priorities), including significant experience working cross-functionally and in global teams knowledge and understanding of cultural differences and diversity issues.
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