Director, Labsqa/audit Quality Assurance, R&d
hace 4 meses
**Director LabsQA/Audit Quality Assurance, R&D Quality Assurance**
**About AstraZeneca**
**Locations: On site 3 days in either Luton UK, Gothenburg SE, Barcelona ES, Mississauga CA or Gaithersburg US**
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we are pioneering new frontiers by identifying and treating patients earlier, working towards the aim of eliminating cancer as a cause of death.
**Come and join our AZ team where you will play a pivotal role in this exciting period of development**
As the independent second line assurance function for R&D, our mission in Quality Assurance is to achieve enduring excellence in auditing, quality management, quality risk assessment and enhance the R&D quality mindset for the benefit of our patients. In view is the rapid expansion of Personalised Medicine, companion diagnostics and digital health within AstraZeneca.
The job holder is responsible for one or multiple of the following areas:
- Actively lead or contribute to the strategic direction for a risk based assurance programme of in-vitro diagnostic medical devices’ specifically companion diagnostic and software as a medical device.
- Designs, manages and continuously improves an effective risk-based assurance programme for assigned GXP or regional area (i.e. APAC)
- Leads, plans and conducts the most complex audits in several GxP areas.
- Leading and/or providing oversight to major regulatory inspections and provision of expert advice to Senior Managers on emerging regulatory issues
- Managing business relationships with stakeholder groups and senior leaders, including management of significant CAPAs in collaboration with owning business functions
- Acts as an expert in audit and GxP assurance and provides mentorship and coaching to audit staff
- Conducts audits
**Key Responsibilities**:
- Audit_
- Provides expert input and support to the Supplier Quality Assessment portfolio of work, especially within the field of in-vitro diagnostics and medical devices.
- Plans, leads, conducts and reports complex audits in all or some of the GxP/medical device areas, and types e.g. investigator site audit, system or process audits and supplier audits.
- May maintain and update the resource management system for a QA region in a timely manner (i.e. APAC)
- Conducts due diligence activities as assigned
- Works with contract personnel or consultants to prepare, conduct and report outsourced audits as required
- Monitors risk and compliance intelligence for assigned GXP/medical device area
- Communicate and assess the standard of audits expected and delivered in their area of responsibility (as applicable)
- Leads directed (For Cause) audits.
- Capa_
- Assesses need for, and assists in development of CAPA plans, approves and monitors plans to completion
- Inspection _
- Provides QA oversight and/or management of regulatory GxP/medical device inspections
- Leads or supports Quality Assurance Associate Directors, to lead and prepare for regulatory inspections, including providing pre
- inspection training to the organisation as needed.
- Job specific Accountabilities
- Provides responsive and proactive quality and compliance advice to defined customers, effectively influence assigned area by being relevant GxP/medical device/quality system expert.
- Support quality and compliance risk management for functional area using risk framework standards to define risk and develop mitigation recommendations
- Maintains strong business relationship with relevant business partners
- Provide effective compliance reporting to senior management and contributes to strategic QA governance forums
- Contributes to functional budget management
- Travel expected
- General Accountabilities_
- Ensures own tasks are performed to current practices and in accordance with company policies, standards, SOPs and guidelines
- Promotes a culture of ethics, integrity and continuous improvement that focuses on delivering efficiencies and planned business benefits
- Communicates effectively with QA colleagues and business collaborators at all levels
- Maintains knowledge of relevant industry information affecting quality and compliance arena
- Leads training for colleagues and business collaborators as required.
- Involved in and may lead the development and/or revision of QA processes, projects and tools
- Coaches and mentors QA colleagues
- Provides general support related to regulatory authority inspections as and when required
**Requirements**:
- Degree level education r equivalent experience
- Knowledge of relevant medical device regulations and guidance’s e.g. FDA 21 CFR 820, FDA IVD, EU IVD Regulations; ISO standards for medical devices
- Significant experience in pharmaceuticals
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