QA/qc Manager

hace 3 meses


Guadalajara, México AstraZeneca A tiempo completo

At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality.

We’re inspired by the things that seem impossible. Here, we see the impact of our collective ideas and expertise, and the power of science to deliver them.

As the QA/QC Manager for Corporate Giving Services (CGS), you will be a member of the team Contracting, Legal, and Compliance Operations (CLCO) team within the Global Business Services (GBS) business unit and will be responsible for developing and managing the quality control and quality assurance program. Within this capacity, you will represent compliance and audit’s perspective in contributing to the design, launch and management of the CGS QA/QC governance and operating model.

The QA/QC Manager will report to the Director, Corporate Giving Technology. The QA/QC Manager will provide quality support across the technical and operations team to monitor compliant and timely delivery of services and technology. The incumbent will be responsible for the development, implementation and maintenance of the quality management process for CGS.

**Major Responsibilities**:

- Develop the overall strategy for Corporate Giving Services QA/QC, including External Funding, Employee Giving, and Single Patient Early Access (SPEA)
- Enhance the operations/service line Quality Score metrics and perform monthly reviews to capture an overall Quality Score for the service and technical team
- Review External Funding requests to ensure they comply with AstraZeneca’s Global External Funding Standard and SOP (ex. requests do not mention products, requests are not commercial in nature, align with the overall definition of External Funding, etc.)
- Collaborate with the teams on maintaining the business continuity plan, including but not limited to ensuring testing on an annual basis and updating as needed with department expansion opportunities
- Develop, communicate and continuously improve CGS policies standards and procedures
- Identify, manage and resolve quality, compliance risks and issues and oversee resolution and reporting
- Assure process meets regulatory, global and local market specific requirements
- Manage routine audits and assessments and ensure audit readiness
- Actively identify and engage in risk management activities including mitigation and escalation of such risks
- Ensure CGS Quality requirements are embedded throughout project and service lifecycle activities
- Ensure system/project compliance with security and privacy requirements
- Specialize in Quality Management and Compliance and recommend appropriate validation approaches for systems and process (if applicable).
- Monitor Compliance & Quality requirements that CGS products and services must effectively comply with
- Expand the monitoring and auditing plan for service line and perform
- Monitor performance and process adherence against all users and company policies and procedures
- Ensure team and business adherence to first line monitoring and reporting
- Implement preventive measure and corrective action plans for process and system nonconformities and defects
- Continuously explore opportunities to innovate the QA/QC process and automate controls
- Proactively identify, monitor and communicate regulatory or compliance changes that could impact the QA/QC process
- Make recommendations for corrective and preventative controls or actions
- Work closely with the business partners, the services team, business stakeholders, the deployment lead and process and technology lead to ensure controls and violations are effectively communicated and mitigated
- Provide continuous process improvement support across service/project

**Required Education & Experience**
- BA/BS business, IT, engineering, science or other relevant field
- 3+ years of experience in QA department or related role
- Experience with audits and compliance control frameworks
- Quality certification (desired)
- Strong decision making and problem solving skill
- Excellent planning and organization skills with demonstrated multi-tasking and project management skills
- Ability to uphold regulator, company and customer standards
- Excellent interpersonal skills
- Ability to delegate without authority
- Effective verbal, listening and written communication skills
- Strong interpersonal skills
- Demonstrated ability to think strategically; leadership and influencing skills


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