Senior Auditor Cell Therapy Quality

AstraZeneca • Gaithersburg, MD

9d • Hybrid

About The Position

The Senior QA Auditor positions establish a continuum at the senior lever for carrying out more challenging audits. These positions are responsible for audits of AstraZeneca Cell Therapy manufacturing sites, contractors, suppliers, due diligence and other audits where a higher level of skills and experience is required. Audits are conducted in accordance with local and international regulations/guidelines and company quality standards to assure compliance with cGMP`s. The incumbents possess advanced audit skills and specialised knowledge in one or more different areas e.g. sterile manufacture, API´s, excipients and packaging etc. The Senior QA Auditor position is an experienced and proven auditor with a strong background performing audits regionally/globally. The individual is required to be fully versed in the interpretation and application of cGMP requirements and expectations within their region but also experience of overseas regulatory standards. The job holder is responsible for conduction independent appraisals of quality and compliance systems, procedures and activities relating to GMP in order to determine their effectiveness in meeting requirements in a risk-based manner and ensuring AstraZeneca management are informed of the compliance status and any significant issues.

Requirements

• 10 years experience in a QA environment with increasingly responsible job requirements including audit experience
• Extensive knowledge of Cell Therapy Products and Cell Therapy Specific Regulations
• Bachelors degree in a scientific discipline
• AZ business language in English
• Self-directed and highly motivated team player with solid organizational capabilities
• Cross-cultural awareness and sensitivity
• Excellent written and verbal communication skills, with and 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

Nice To Haves

• Experience overseeing auditing
• Experience in other GXP areas (GLP, GCP)

Responsibilities

• Conduct independent appraisals of quality and compliance systems within technically advanced manufacturing settings.
• Performs complex and demanding domestic and international (subject to experience) audits of suppliers of raw materials, packaging components, drug substance or other process intermediates, and finished drug products, or contracted services.
• Audits are conducted in accordance with cGMP´s, ISO Standards, IPEC, ICH Q7A and company procedures.
• Plans, coordinates and conducts scheduled or unscheduled cGMP audits of complex internal AstraZeneca Operational departments to ensure compliance to CGMP´s and AstraZeneca standards.
• Provide clear and scientifically/technically justified interpretations and support for any audit findings and proposed corrective and preventive actions.
• Liaise directly with local AZ and/or regional and global senior management, where necessary, to ensure issues are understood and proposed actions are acceptable.
• Interpret and apply cGMP regulations and expectations.
• Initiate and maintain close contacts with regulatory agencies and/or industry/professional organizations to keep aware of trends and initiatives in quality assurance, GMP compliance, and inspections.
• Develop and interpret audits findings across the scope of the Global Quality Audit (GQA) in order to communicate trends and provide recommendations to address such developing trends in a proactive manner.
• While maintaining independence, work closely with other QA colleagues to assure common understanding of developing interpretations of cGMP
• Conduct activities and interactions consistent with Company values and in compliance with the Code of Ethics and supporting Policies and Standards relevant to your role.
• Complete all required training on the AZ Code of Ethics and supporting Policies and Standards on time.
• Report potential - issues of non-compliance.

Benefits

• qualified retirement program [401(k) plan]
• paid vacation and holidays
• paid leaves
• health benefits including medical, prescription drug, dental, and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Senior