Manager, Quality Systems
AstraZeneca

Job Info

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Manager, Quality Systems

Location: Gaithersburg, MD

The Manager, Quality Systems is responsible for developing and executing initiatives and projects that contribute to the Site Operations Department Compliance Management strategy. The Manager must look at the company objectives as they pertain to the Site Operations department and develop plans, policies and procedures for compliance management. The Manager provides input to the Regional Maintenance Governance Group, managing and implementing standards for alignment as well as managing change control and audit readiness for global Site Operations' systems. The Manager will also collect and compile data, lead investigations and participate in meetings that discuss the overall adherence to the Oncology R&D compliance program. This role will interface closely with the Quality Assurance department and will also be the Functional Lead in all inspection and audit response activities. This role will seek and coordinate training opportunities, support change management, and ensure audit readiness in the Gaithersburg Site Operations organization.

Major Duties and Responsibilities

• Contribute to the development and implementation of compliance-related policies and procedures affecting US Site Operations.
• Conduct periodic internal reviews to ensure that company policies and procedures are followed.
• Conduct or manage investigations of compliance issues or adverse trends.
• Design or implement improvements in communication, monitoring, or enforcement of compliance standards.
• Assess product, compliance, or operational risks and develop risk management strategies.
• Develop and maintain written policies and procedures related to compliance activities.
• Prepare management reports regarding compliance operations and progress and discuss emerging compliance issues with management.
• Serve as a point of contact for employees and management to seek clarification on issues or dilemmas, or report irregularities.
• Collaborate with other departments and sites to ensure the implementation of consistent corrective action strategies in cases of compliance standard violations.
• Provide or coordinate training on skills development, compliance related topics, policies, or procedures.
• Keep informed regarding pending industry changes, trends, and best practices and assess the potential impact of these changes on organizational processes.

Requirements/Qualifications:

• Gather product impact analysis for metrology and maintenance deviations
• Gather product impact analysis for EM and Utility deviations
• Create standard templates for data collection and deviation reports
• Develop metrics and reporting
• Prepare presentations, reports, flow diagrams, graphs and any other documents
• Database programming and entry

Education:

• Bachelor's Degree or equivalent

Experience:

• 3-5 years' experience

Special Skills/Abilities:

• Language Skills: Strong verbal and written communication skills, organizational, presentation, and analytical ability. Ability to communicate effectively with customers or employees of organization.
• Flexibility, fast turnaround, excellent technical skills and high motivation to fulfilling requests to meet critical timelines supporting work of others.
• Computer Skills: Microsoft SharePoint and MS Office applications, Adobe Pro, AZDoc/ECMS, SABA Cloud, SAP, ProCal, BMS, and TrackWise/EQV.

This job has expired.