Associate Director, APAC Quality Assurance
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 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
• Management of significant CAPAs related to audit and/or inspection findings in collaboration with functions owning the issues.
• Managing business relationships with defined stakeholder groups for the quality management activities (quality risk, issues, process etc.).
ROLE & RESPONSIBILITIES
Audit
• 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
• Leads Supplier qualification activities (SQA) as assigned
• Identify and assess gaps during supplier qualification assessments
• Supports Due Diligence activities as assigned
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 inspections
• Collaborates with Quality Assurance lead, to manage and prepare for regulatory inspections as assigned including providing training to the organisation as needed.
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 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
REQUIREMENTS
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
• skills – curious to understand business environment
• 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
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.
