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