AstraZeneca Pharmaceuticals LP IT Quality Manager in Guadalajara, Mexico
AstraZeneca is one of the world’s most exciting bio-pharmaceutical companies. From scientists to sales, lab techs to legal, we’re on a mission to turn ideas into life-changing medicines that improve patients’ lives and benefit society. We are active in over 100 countries and we employ over 59,000 people. We are an innovation-driven biopharmaceutical with over 60 years of experience.
AZ Global Technology Center Guadalajara
The AstraZeneca GTC in GDL, is a vibrant, high-energy facility, fully equipped to support our business with 400 IT professionals. We continuously improve our IT environment by innovating for competitive advantage. We are fully committed to redefine and provide support to enterprise-wide IT solution platforms, infrastructure and services.
The IT Strategy and Performance (S&P) organization is responsible for driving the IT Strategic Plan, the IT Operating Model and the overall direction under which IT operates as a business unit.
The Quality Management function is established to cover;
Project Quality Management
Service Quality Management
Regional / Campus Quality Management
Site Assurance Activities
This function will also consult and educate business and the broader workforce on effectively integrating Compliance Requirements into all IT Lifecycle activities.
The IT Quality Manager will facilitate the realization of the Quality Management strategy for specific areas in Quality Management.
The role will be accountable for the application of Quality Management processes and services to assure that projects, systems, solutions and services delivered by IT and their 3rd party suppliers meet AZ internal and external regulatory requirements
The role will act upon risks and issues in order to raise compliance and quality levels within IT and the business
Supports the development and roll out of training, education and awareness campaigns for quality and compliance.
Contributes to the continuous improvement of IT Polices and standards
Candidate Knowledge, Skills & Experience
BA, BS in Computer or Life Sciences with 3-5 years of experience in the pharmaceutical industry regulatory requirements
Understanding of global Pharmaceutical Regulations (FDA, Annex 11, Sarbanes Oxley, etc.)
Knowledge of industry best practice and standards such as GxP, CMMI, SPI, GAMP, ITIL, COBIT, Risk Management
A working knowledge of governance of 3rd party relationships.
It is expected that the candidate would come from a good solid IT background, with a specialist in Quality, Compliance including Sarbanes Oxley.
Experience of contributing to implementation of the Quality and/or Compliance strategy with the ability to prioritise and understand the impact of the decisions made
Experience of operating across business functions and geographies in large, complex and sometimes uncertain IT environments
Strong communication, influencing and relationship building skills
Strong change leadership and team working skills
Fluent business english- 80%
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.