Audit Manager - Audit QA
Job Profile: Audit Manager – Audit QA
Work Locations: Onsite with flexibility in Gaithersburg, MD or Mississauga Ontario Canada
Do you have an interest in being a Good Clinical Practices (GCP) auditor? Do you have a passion for promoting and optimizing quality and efficiencies? Do you enjoy providing data-driven insights? Would you like to apply your expertise to ensure that quality is a key factor in AstraZeneca’s sustainable business success? Then this role might be the one for you!
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization 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.
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 approach for the benefit of our patients.
R&D QA commits to provide our partners with an experience that is driven by patient protection and data integrity, represents regulators current and future views, optimizes quality thinking and promotes a ‘right from me’ approach, focuses on issues that matter, minimizes risks and drives inquisitive outcomes and provides simple, structured and efficient systems, with up-to-date quality information.
Come and join our AZ team where you will play a pivotal role in this exciting period of development!
What you’ll do
- Lead, guide and support the execution of GCP quality assurance audits.
- Support lead auditors in the planning, conduct and reporting of more complex audits such as Process / System, External supplier
- Work with contract personnel or consultants to prepare, conduct and report outsourced audits
- Support Supplier qualification activities (Operational Due diligence - ODD) as assigned
- Identify and summarize gaps during ODD
- 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
- Assist in leading the development and revision of Quality Assurance processes and procedures in the U.S.
- Assess and communicate relevant industry information and changes regarding compliance to colleagues and clients
- Work collaboratively with Quality Assurance team members, as well as external consultants, managing regulatory inspections, conducting outsourced audits, and providing internal training as needed
- Support quality and compliance risk management for functional area using risk framework standards to define risk and develop mitigation recommendations
- Travel is expected
Required Experience, Skills, and Qualifications
- Bachelor’s degree or foreign equivalent in one of the medical sciences (Medicine, Pharmacy, Biology, Chemistry)
- 2+ years experience in biotech or pharmaceutical industries
- Excellent analytical, written and oral communications skills
- High ethical standards, honest, operating with absolute discretion
- Strong collaborative, influencing and interpersonal skills – curious to understand business environment.
- Fluent in expressive and receptive English in speech and written communications
- Skilled at managing & using various types of technology
- Ability to maintain and create professional networks with collaborators
- Experience in leading GxP Audits
- Project management experience, PMP a plus
- Experience of Regulatory Health Authority GxP inspections
At 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.
Employer of Choice - Competitive salary and benefits package apply
AstraZeneca offers a total rewards program that addresses competitive compensation, bonus and equity shares in the business. We offer a comprehensive benefits program including health, vision, dental and life insurances, plus a generous paid time off program and let's not forget the array of other benefits you can utilize based upon your personal wants and needs.
We operate in a highly collaborative environment and we embrace 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.
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.