Senior Auditor, Global Quality
Senior Auditor, Global Quality
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1 Vacancy
Job Description
Senior Auditor Global Quality
Location: Gaithersburg MD
Introduction to role
Are you ready to take on a meaningful role that requires advanced audit skills and specialized knowledge Due to internal promotion we are search for a Senior Auditor for Global Quality to join our team!
As a Senior QA Auditor at AstraZeneca youll conduct audits of manufacturing sites contractors and other areas where your expertise is crucial. Your work will ensure compliance with local and international regulations and company quality standards. With your strong background in performing audits regionally and globally youll interpret and apply cGMP requirements conduct independent appraisals and keep AstraZeneca management informed of compliance status and significant issues. Are you prepared to make a difference
Accountabilities
- Conduct independent appraisals of quality and compliance systems within technically advanced manufacturing settings.
- Perform complex domestic and international audits of suppliers and contracted services in accordance with cGMPs ISO Standards IPEC ICH Q7A and company procedures.
- Plan coordinate and conduct scheduled or unscheduled cGMP audits of internal AstraZeneca Operational departments.
- Provide clear interpretations and support for audit findings and proposed corrective actions.
- Liaise with local regional and global senior management to ensure issues are understood and actions are acceptable.
- Interpret and apply cGMP regulations and expectations.
- Demonstrate proven written and oral skills in cross-cultural settings.
- Maintain close contacts with regulatory agencies and industry organizations to stay informed on trends in quality assurance.
- Develop and interpret audit findings to communicate trends and provide proactive recommendations.
- Collaborate with QA colleagues to ensure common understanding of cGMP interpretations.
- Conduct activities consistent with AstraZeneca values and compliance with the Code of Ethics.
Essential Skills/Experience
- 5-10 years experience in a QA environment with increasingly responsible job requirements including audit experience
- Bachelors degree in a scientific field
- AZ business language in English
- Self-directed and highly motivated teammate with solid organizational capabilities
- Cross-cultural awareness and sensitivity
- Excellent written and verbal communication skills with an ability to manage stressful and confrontational situations to positive outcomes
- Ability to travel extensively (up to 60% of time local/regionally/global)
- Proven ability to continually refresh cGMP interpretation and application through self-study and external involvement with industry groups
- Solid knowledge of modern quality systems risk assessment corrective and preventive action development and execution and other evolving principles across the global compliance arena
- Direct and increasingly responsible audit responsibilities
- Solid awareness of related functional areas such as product development
Desirable Skills/Experience
- Overseas auditing experience
- Experience in other GXP areas (GLP GCP)
- Ability to speak Spanish fluently
At AstraZeneca we are driven by a commitment to excellence. Our forward-looking approach empowers us to innovate continuously ensuring we improve outcomes for patients. We take quality seriously drawing lessons from others to drive our modern approach forward. Here youll feel empowered to make decisions that put patients first. Working collaboratively across functions we adapt quickly to get new medicines out faster while maintaining a sharp focus on patient-centricity. Our inclusive community shares knowledge and expertise fostering a sense of camaraderie that makes AstraZeneca an inspiring place to grow your career.
Ready to make an impact Apply now to join our team!
The annual base pay (or hourly rate of compensation) for this position ranges from $124826 to $187239.Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime pay offered may vary depending on multiple individualized factors including market location job-related knowledge skills and addition our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles)to receive a retirement contribution (hourly roles) and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program 401(k) plan; paid vacation and holidays; paid leaves; and health benefits including medical prescription drug dental and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired employee will be in an at-will position and the Company reserves the right to modify base pay(as well as any other discretionary payment or compensation program) at any time including for reasons related to individual performance Company or individual department/team performance and market factors.
Date Posted
28-Jul-2025Closing Date
Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and furtherance of that mission we welcome and consider applications from all qualified candidates regardless of their protected characteristics. If you have a disability or special need that requires accommodation please complete the corresponding section in the application form.
Required Experience:
Exec
Employment Type
Full-Time
