At AstraZeneca, we are united by a common purpose: to push the boundaries of science to deliver life-changing medicines. This purpose underpins everything we do. Our work helps to make hearts healthier, to help people breathe easier, and to help more people survive cancer. Every single day, we make a difference by delivering potentially life-changing medicines to millions of people worldwide and by leading breakthrough science that promises to transform the treatment of disease.

Our purpose is ambitious and so is our approach. Becoming a more agile and creative company means building a multifaceted, inspiring culture where we celebrate diverse, ambitious thinking and act with a sense of urgency. We are courageous, taking risks and learning from both success and failure. We are curious, creative, and open to new ideas and ways of working. Above all, we are passionate about science and driven to always put patients first. Join us and be part of an outstanding place to work; an environment that energizes and empowers each of us to achieve our goal to develop and deliver medicines.

The ‘R&D GLP& Research Quality Assurance team’ provides excellence in auditing, quality management, quality risk assessment and enhancement of the R&D quality mindset for the benefit of our patients across the R&D operations at AstraZeneca.

As ‘Associate Director, QA’ based in either Cambridge, UK you will be responsible for performing audits within a variety audit programs: GLP (as applicable to non-clinical safety and toxicology studies) , Lab GCP, vendors, Human Biological Standard and AZ General laboratory standard. For this current opportunity we are primarily seeking an individual with prior experience relating to GCP in the laboratory environment e.g. bioanalytical labs, central labs and diagnostic labs, both auditing and providing compliance related advice and assessments. However, significant experience of auditing GLP would also be an advantage.

The successful person will be 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 leading the issues.
• Providing pragmatic compliance advice and support

This role is best suited to candidates with a high degree of integrity and critical thinking agility. It is also important to have a pragmatic attitude and the ability to navigate complex situations. Importantly, you will need to have a proactive attitude and the personal credibility to effectively communicate and establish trust with stakeholders across the globe.

Key accountabilities:

Audits

• Plans, leads, conducts and reports audits in assigned GxP areas, and types e.g. facility, study, report, 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

Inspection Support

• Collaborates with Quality Assurance Lead to manage and prepare for regulatory inspections, including providing pre- inspection training to the organisation as needed
• Provides QA oversight and/or management of regulatory GxP inspections

Capa

• Assesses need for, and assists in development of CAPA plans, approves and monitors plans to completion

Job Specific General Accountabilities

• 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

Quality Assurance 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 the need arises.
• 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

To be successful in this role you will need:

• Degree level education
• Experience in pharmaceuticals or a related industry
• Excellent analytical, written and oral communications skills
• Proficient 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 build professional networks with stakeholders

Date Posted

Closing Date

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 authorization and employment eligibility verification requirements.