Manager Audit Quality Assurance (GCP R&D)

Job Title: Manager Audit Quality Assurance (GCP)

Job Location: Hybrid w 3 days/wk office based in Gaithersburg MD

At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe. Sound good?

Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our offices are purposely designed with collaboration in mind, providing creative spaces where teams can come together to strategize, brainstorm and connect on key projects!

Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we’re taking bold action to address some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.

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 mentality for the benefit of our patients.

The job holder is accountable for:

• Planning, leading, conducting and reporting on audit activities for R&D GCP risk-based audit programs
• Support of GCP inspection activities
• Management of CAPAs related to audit and/or inspection findings in collaboration with QA colleagues and functions leading the issues.
• Support of QA activities such as CAPA tracking & follow-up

The Quality Assurance GCP accountabilities are split between the QA teams as below:

• Audit team – GCP and GVP
• LabsQA – Lab (GCP) and GLP

Audit

• Plans, leads, conducts and reports audits in assigned GCP areas, such as investigator site and/or project audits
• Supports lead auditors in the planning, conduct and reporting of more complex audits such as Process / System, External supplier
• Works with contract personnel or consultants to prepare, conduct and report outsourced audits
• Supports Supplier qualification activities as assigned

CAPA

• Assesses need for, and assists in development of CAPA plans, approves and monitors plans to completion for assigned audits
• Assists with the continuing follow-up of agreed audit CAPA actions from across QA to assist in the monitoring of QA Key Performance Indicators

Inspection

• May support Quality Assurance colleagues to prepare for regulatory inspections and assist with planning and logistical arrangements

General Accountabilities

• Ensures own tasks are performed to current practices and in accordance with company policies, standards, SOPs and guidelines
• Promotes an environment of ethics, integrity and continuous improvement that focuses on delivering efficiencies and planned business benefits
• Communicates effectively with QA colleagues and business partners
• Maintains knowledge of relevant industry information that affects the quality and compliance (Q&C)
• May provide responsive and proactive Q&V advice to defined customers.
• Support Q&C risk management for functional area using risk framework standards to define risk and develop mitigation recommendations
• Travel expected

Education, Qualifications, Skills, and Experience

• Bachelors degree level education or equivalent experience
• 3+ years experience in pharmaceuticals or a related industry
• Excellent analytical skills, as well as written and oral communications skills
• Fluent in written and spoken English
• Highly ethical individual, honest and capable of operating with absolute discretion
• Collaborative, able to influence colleagues, and has good interpersonal skills
• Curious to understand business environment
• Skilled at running equipment & using technology
• Ability to develop professional networks with team members and customers alike

Desirable Skills and Experience:

• Audit Experience
• Supplier qualification
• Experience of regulatory health authority GxP Inspections

Employer of Choice:

At AstraZeneca we’re dedicated to being a phenomenal Place to Work. Where you are empowered to push the boundaries of science and ignite your entrepreneurial spirit. There’s no b