Senior IT Quality Manager – Mergers & Acquisitions

Job Title: Senior IT Quality Manager – Mergers & Acquisitions

Career level: E

Introduction to role

Are you ready to take on a pivotal role in ensuring the quality and compliance of our Mergers & Acquisitions projects? As a Senior IT Quality Manager, you will be at the forefront of integrating systems and services that meet both internal and external regulatory standards. Your expertise will guide multidisciplinary teams to navigate complex regulatory landscapes and drive decision-making that mitigates risks. Join us in shaping the future of our IT landscape!

Accountabilities

• Accountable for the application of Quality Management processes and services to assure that Mergers & Acquisition (M&A) projects, integrations, systems, solutions and services delivered by IT and 3rd party partners meet AZ internal and external regulatory requirements.
• Demonstrates leadership and serves as the subject matter expert on regulations and compliance across multidisciplinary teams to ensure compliance.
• Drives compliant decision-making and risk mitigation across cross-functional teams.
• Act upon risks and issues 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 Policies, standards and procedures, as well as those pertaining to M&As.
• Collaborates with system/business process owner and M&A IT Deal Leads to complete or update the Regulatory Impact Determination (RID) as per the procedure to ensure an understanding of the Regulatory applicability (GxP, SOx, Data Privacy etc.), business, technical, software category, and regulatory risks for computerised systems, as applicable.
• Review of System lifecycle deliverables including RID, specifications, protocols, reports, and validation lifecycle deliverables, aligned with quality and compliance requirements.
• Review & approve M&A project deliverables including M&A Transfer Plan, Report and Data Migration activities.
• Participate in the review and approval of Exceptions, CAPA, Deviations, Changes, Incidents and Problems ensuring timely completion and update of System Lifecycle deliverables.
• Collaborates with the IT Project Manager to define the Quality Plan, processes, validation planning, and reporting processes.
• Reviews and approves the acquisition/divestiture/collaboration/repatriation/joint ventures/spin-offs plans, reports and procedures of data transfer from source systems from/to the purchaser/seller/partner/AZ target system, as appropriate.
• Review and approve the Workstream approaches and report(s), as applicable.
• Act as a QM point of contact for any potential internal and/or regulatory inspections.
• Driving accountability for the completeness, accuracy and currency of Quality related data through effective monitoring, tracking and reporting.
• Process authoring, ownership, lead, quality review and/or approval as appropriate.
• Provides guidance and support to M&A projects involving the development or introduction of new tools or systems to streamline M&A processes.

Essential Skills/Experience

• BA, BSc in Computer or Life Sciences or equivalent, with at least 3-5 years of experience in the pharmaceutical industry regulatory requirements
• Experience of providing regulatory support including validation of laboratory, manufacturing and business applications.
• Knowledge of industry good practice and standards such as ISO 9000, ISO 27002, CMMI, GAMP, GxP, ITIL, S404 Sarbanes-Oxley
• Experience of contributing to implementation of a 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, capable of discussing technical IT terms with a non-technical business audience
• Strong change leadership and team working skills
• Ability to make pragmatic decisions by analysing complex situations and assessing risks
• Concern for impact, analytically minded and able to prioritise and plan using initiative
• High levels of drive, energy, resilience and a desire for professional excellence
• Ability to hold self and others accountable for actions

Desirable Skills/Experience

• Broad IT management experience including project or service management
• Familiarity with technical concepts in infrastructure or applications
• External qualifications such as ISPE PCC CPIP and ISACA CISM
• Understanding of Lean principles, tools and techniques
• Third Party Suppliers / External Consultants
• External stake holders from other companies

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

At AstraZeneca, innovation is at our core. We are committed to developing groundbreaking therapeutics that challenge convention. Our diverse teams thrive on collaboration, drawing on varied perspectives to uncover new insights. With a focus on lifelong learning and professional growth, we empower our employees to take smart risks in pursuit of industry-leading growth. Join us in our mission to make a meaningful impact on patients' lives.

Ready to make a difference? Apply now to join our dynamic team!

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.