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Associate Director Audit Quality Assurance
hace 3 meses
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.
The Associate Director Audit Quality Assurance is responsible for:- Planning, leading, conducting and reporting audit activities for R&D GxP risk-based audit programs
- Delivery of proactive GxP inspection support and management
CAPAs related to audit and/or inspection findings in collaboration with functions owning the issues.
The Quality Assurance GxP accountabilities are split between the QA teams as below:
- Audit team
- GCP, GVP including strategy where applicable
- Plans, leads, conducts and reports audits in assigned GxP areas, and types e.g. investigator site audit, system or process audits and vendor audits.
- Participate in and may lead directed (For Cause) audits.
- Works with contract personnel or consultants to prepare, conduct and report outsourced audits
- Supports Due Diligence activities as assigned
- Leads Supplier qualification activities (Operational Due diligence ODD) as assigned
- Identify and assess gaps during supplier qualification assessments
CAPA
- Assesses need for, and assists in development of
CAPA plans, approves and monitors plans to completion
- Provides QA oversight and/or management of regulatory GxP inspections
- Collaborates with Quality Assurance lead, to manage and prepare for regulatory inspections as assigned including providing training to the organisation as needed.
- 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 stakeholders
- Maintains knowledge of relevant industry information affecting quality and compliance arena
- Leads training for colleagues and business stakeholders as required.
- Involved in and may lead the development and/or revision of QA processes, projects and tools
- Mentors QA colleagues
- Provides general support related to regulatory authority inspections as and when required
- Provides responsive and proactive quality and compliance advice to defined customers, effectively influence assigned area by being relevant GxP/quality system expert
- Support quality and compliance risk management for functional area using risk framework standards to define risk and develop mitigation recommendations
- Travel expected
Education, Qualifications, Skills and Experience
Essential
- Degree level education or equivalent experience
- Experience in pharmaceuticals or a related industry
- Excellent analytical, written and oral communications skills
- Fluent in written and spoken English
- High ethical standards, trustworthy, operating with absolute discretion
- Strong collaborative, influencing and interpersonal
- Skilled at managing & using technology
- Ability to maintain and create professional networks with stakeholders
- Supplier qualification
Desirable
- Project management experience
- Experience in managing regulatory health authority GxP Inspections
- Key Account management
- Audit expertise
Key Relationships to reach solutions
Internal (to AZ or team)
- Other Audit and Quality Assurance Teams
- Legal and Global Compliance
- Stakeholder Leadership Team
- Audit sponsors
External (to AZ)
- Contract QA personnel
- External Quality Assurance network
- AZ subsidiary personnel
- External Collaborators
- Regulatory agencies
