Senior Auditor, Global Quality

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, you'll 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, you'll 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
• Bachelor's 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, you'll 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 $124,826 to $187,239. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.  In 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

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In 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.