AddressDirector 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 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 collaborators
Experience in managing regulatory health authority GxP Inspections
Audit experience
Desirables:
Project management experience
GxP (GCP, GLP) Knowledge
Experience of six sigma/lean/process improvement tool
Key Account management
AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.
So, what’s next:
Are you already envisioning yourself joining our team? Good, because we can’t wait to hear from you!
*** We will be reviewing applications and shortlisting on a rolling basis - as such we reserve the right to withdraw this vacancy ahead of the stated closing date
Competitive salary and benefits package on offer.
The successful candidate will have access to a flexible employee benefits fund, including holiday purchase and flexible time off, pension contributions, Share Save Plans, A performance recognition scheme and a competitive, generous remuneration package.
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
