AstraZeneca Pharmaceuticals LP IT Quality Senior 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 Senior Quality Manager/Associate Director, will specialise in Quality Management and Compliance and is able to recommend appropriate validation approaches for complex systems based upon their experiences.
Assumes leadership role to actively and independently steer project and service teams from a regulatory compliance and quality management perspective, to meet company policies and government regulations.
Takes a lead in setting and interpreting both top level IT and specialist Quality and Compliance policies and standards.
Maintains proactive IT and business engagement and collaboration, to ensure Quality Management deliverables are aligned with customer expectations, IT strategy and meet the needs of AZ.
Candidate Knowledge, Skills & Experience
BA, BS in Computer or Life Sciences with 10-15 years of experience in the pharmaceutical/Life Sciences IT industry providing Quality GxP compliance support in a global role
Management experience with direct reports 5+ years
Demonstrated ability to independently lead the IS Quality input to validation projects in support of IS projects. Thorough understanding of pharmaceutical regulations, US and European with applicability.
Ability to collaborate with leadership across IT Quality, and Compliance and Risk and Business units.
Experience of contributing to defining the strategy for Quality and/or Compliance with the ability to prioritise and understand the impact of the decisions made
Experience in operating across business functions and geographies in large, complex and sometimes uncertain IT environments
The ability to apply regulatory requirements to project & service delivery, assuring a pragmatic approach
A self-starter with high levels of drive, energy, resilience and a desire for professional excellence
Ability to drive change and performance in supplier and internal AZ IT functions.
Ability to prioritise, re-schedule or adapt to changes
Ability to communicate both written and orally at all levels of the organization
Proven ability to interpret and communicate technical requirements into business language
Strong leadership skills
Knowledge of industry good practice and standards such as GAMP, GxP, ITIL, s404 Sarbanes Oxley, Risk Management, PMI
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.