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Regulatory Platforms Manager - OFR0251

Location Gaithersburg, Maryland, United States Chennai, Tamil Nadu, India Bengaluru, Karnataka, India Cambridge, England, United Kingdom Gothenburg, Västra Götaland County, Sweden Job ID R-121542 Date posted 13/10/2021

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and spark your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. We foster an inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development.

Technology at AstraZeneca is a home for purposeful disruptors!

Here our work has a direct impact on patients – transforming our ability to develop life-changing medicines. We empower the business to perform at its peak and lead a new way of working, combining cutting-edge science with leading digital technology platforms and data. All with a passion to impact lives through data, analytics, AI, machine learning and more. In Business Partnering we will provide strategic partnership to the ITLT and the broader IT organization. We will drive continuous improvement and alignment, as well as preparing the organization to meet the needs of the future. As the Senior Business Partner you will report to the Head of the IT Business Performance Team in IT's Strategy & Performance function.

Job Description:

AstraZeneca is making significant investments in our IT Platform Capabilities to manage business demand around IT solutions and deliver value faster adopting Agile DevOps delivery model specifically tailored towards individual platform requirements for R&D Quality and Regulatory Value Stream.

 As part of this capability built we are looking for the individual to manage the technical delivery of our R&D Quality and Regulatory value stream and its associated Platform teams creating a delivery organization focused on delivering Enterprise  Regulatory Vault  (ERV) and Quality Assurance  platform supporting the Global Regulatory Excellence and Quality Assurance Function within Chief Medical Office Organization.

This role will ensure that common architecture and technology landscape decisions support both business and IT capability strategy, and thus the platform enabled solution deliverables are aligned with relevant AZ architecture and software engineering standards, blueprints and roadmaps. The role will assess and review the work of Platform lead and their respective teams and create a balance between the immediate and the strategic priorities based on the overall IT strategic blueprint and Platform roadmap strategies.

Our vision is to deliver the best R&D IT capabilities for Regulatory and Quality Assurance, which we define as agile, responsive and fit-for-future. Our goal is to engage with our stakeholders as a strategic partner in delivering life-changing medicines to our patients. The desired effect of this role is to take accountability as a leader for delivering a ‘Best in Class’ IT experience for the Regulatory and R&D Quality Assurance across the enterprise, including operations, manufacturing and R&D.

Role Overview:

Note: This is NOT a software testing or QA role. This is a role that will lead teams that will maintain and build upon regulatory and quality systems specific to pharmaceutical drug development, clinical, and submission processes.

What you´ll do

  • As a Platform Manager for Regulatory and Quality Assurance Value Stream you will be responsible to lead the platform strategies and related roadmaps in close collaboration with respective IT Platform Lead, Product Managers and associated Capability team consisting of Business Relationship Managers, Capability Leads, Domain Solution and Information Architecture.
  • The Regulatory and Quality Assurance Value Stream IT Platform Manager  will have the opportunity to collaborate with  Platform Leads, Senior  Platform Engineers, DevOps Leads, Release Engineers, and Solution/Integration Architects within AZ to establish best practices for software development and engineering, business analysis, solution designs, enterprise software integration and project management delivery practice adopted for the  platform ways for working in Agile DevOps Delivery Model.
  • Work in partnership with the Business Product Directors/Managers you will lead and oversight the value stream enabled cross platform initiatives and work closely with Platform Lead(s) and BRM to achieve your goals. The Platform consist of a wide range of product components where we are harmonizing both backend and frontend solutions into a service catalogue of solutions enabled within Platform framework.
  • Assesses business and technical requirements and business priorities as well as leads high-level investigations or analysis aligned to the strategy. 
  • Leads, Coaches and Mentors a team of Platform Leads, Release Managers, DevOps Leads, Senior technical Platform Engineers and Release Engineers while applying business acumen to deliver high-valued results.
  • Influence the designs for sophisticated technical solutions in a balanced and manageable way using existing and new platforms, in close collaboration with enterprise and solution architecture and software engineering practice.
  • Contributes as a technology advisor identifying technical implications and providing strategic and technical recommendations to support business objectives in line with overall Platform Strategy.
  • Accountable for implementing strategies covering testing, release, and documentation for applicable platforms working through respective Platform lead and DevOps Platform team. 
  • This role requires a hybrid set of technical, business domain, and leadership skills. You are encouraged to perform as a leader-doer with the ability to encourage and motivate an agile and diverse team of authorities in a complex matrix organization. This role is a mix of leading a team and building a relationship of trust with our partners, anchored by good technical and domain expertise and continuous learning and development.
  • Building strong strategic relationships with complex customer groups and senior stakeholders, developing a deep understanding of the short-term and long-term business direction & IT strategy.
  • Facilitating accurate IT Platform demand forecasting, planning, and delivery collaboratively with respective Platform Teams under scope of the R&D Quality and Regulatory Value Stream.
  • Leading technical impact assessments, identifying risks and issues that may affect current and future solutions within the Platform framework.
  • Partnering with key stakeholders such as Product Directors, Capability leads and BRMs on the proactive development of detailed Platform Roadmap working with Platform Lead. 
  • Presenting and gaining buy-in from senior leaders for IT initiatives, leveraging domain knowledge to gain credibility, trust, and commitment.
  • Responsible for technical supplier/vendor assessment and review of SoW and Purchase Orders on behalf of Delivery and Capability leadership team.
  • Perform the hands-on Technology Lead role across multiple initiatives, taking on IT Ownership for identified platforms/systems and collaborating closely with various business departments, other IT resources and our vendors both to develop, maintain and support the IT Platform E2E through offshore delivery centers.
  • Accountable for delivery of current-state system improvements and future-state requirements driving innovation and seeking new technical solutions contributing to the Applications portfolio realignment and thereby consolidating the existing applications into targeted platform framework.

Major Role Key Activities

  • Analyzing: Assess and document platform composition and condition, identify stakeholders and expectations on run (i.e., operations), exploit (e.g., requests) and new and current projects and issues.
  • Defining: Define and develop the platform strategic, roadmap, LRP Planning including relevant performance measures, addressing current issues and challenges, future plans for changes and opportunities for improvement.
  • Engaging: Proactively socialize the platform roadmap with business functions using the platform – and with other platform, process and partnership managers across IT. Collect feedback for improvement, ensure alignment and coordination, and avoid redundancy or conflicting demands.
  • Operating: Execute on the platform roadmap, actively manage the platform as a set of interconnected assets and manage cross-platform dependencies. Present financial show back and planning associated with platform roadmaps in collaboration with IT Capability, BRMs.
  • Evaluating: Assess the health and operational performance of the platform against established metrics. Achieve and improve operational service metrics and/or targets associated with platforms.
  • Problem Solver/Critical Thinker: This role requires someone who can understand the issues, the broader context, and help to develop strategic and specific solutions.
  • Technology Savvy: This role will be benefitted by an individual who is a quick learner and able to utilize different software technologies.
  • Process Implementation & Improvement Experience: The ideal candidate will have experience creating, implementing, and improving global processes, particularly within regulatory operations and quality assurance.
  • Executive Communication. Must communicate and present at the executive level: proficiency in stakeholder buy in, strong cross functional communication, organizational navigation, building rapport across functions and levels of management.
  • Improving: Identify and realize opportunities to increase the value of the platform by extending cost-effective use and/or reducing platform costs through rationalization, consolidation, streamlining, and price negotiation.

Essential Skills/Experience:

This role requires cross IT technical expertise/knowledge and familiarity in all core areas of Regulatory Operations and Quality Assurance Value Stream consists of IT Product Platforms for Regulatory Information Management (i.e. E2E Submission Planning, Content Management, Publishing to Health Authorities, Registration Tracking.) and Quality Assurance.

Technical/Management Expertise:

  • Proven track record to collaborate with teams to help them understand the product’s key capabilities and benefits; understand their needs to enhance adoption of IT Solutions.
  • Worked with customers and leaders to help in validating technical concepts, vision, and roadmaps.
  • Experience working with the team to specify technical requirements for current and future products.  
  • Maintained program objectives, success measurements or key performance indicators (KPIs).
  • Participated in release planning, demonstrations, and retrospectives with development teams.
  • Previous experience in Agile Methodology for backlog tracking, burndown metrics, velocity, and task definition.
  • Familiarity with common SaFe Agile practices, service-oriented environments, and better development practice.
  • Mastery of complex facilitation and dependency management techniques (cross team, cross department).
  • Managed cross team, ART and departmental impediments, planning, collaboration, and coordination.
  • Driven delivery and continuous improvement by utilizing feedback and metrics (quality, delivery rate, etc.) to identify areas of opportunity.
  • Experience working in IT GxP Validated environment adhering to good practices for – CSV (21 CFR Part 11, Annex 11 EU GMP, GAMP 5) including ITIL Service/Change Management framework.
  • Proven track record of working experience across different technology stack ranging for COTs, Cloud based SaaS vs On-prem, LAMP vs WAMP, SQL vs NoSQL, Multi-tier architecture Solutions.
  • Experience working or knowledge related to TOGAF architecture and Ajax Web Development Framework.

Regulatory Information Management:

  • Direct experience with systems such as Veeva Vault, PARAXEL/LIQUENT InSight, CSC Regulatory Tracker, ArisGlobal Register, OpenText, SharePoint, Documentum, FirstDoc/FirstPoint, NextDocs, CARA, Extedo eCTD Manager, TrackWise, or other RIM Solutions.
  • Excellent technical understanding and proven, hands-on experience in technologies such as SharePoint, eCTD Publishing Tools (InSight Publisher/Viewer), Veeva Vault RIM, and off-the-shelf and plug-in software such as DXC Publisher, LORENZ eValidator.
  • Solid understanding in developing Regulatory requirements, such as IDMP, XEVMPD for Regulatory Product data tracking, registration, eCTD for Publishing, SPL for Labeling IT Solutions.
  • Experience to maintain or support a robust data foundation across Global Regulatory Affairs/Operations processes and systems.
  • Knowledge about Submission Assembly (i.e. collecting Regulatory Documents and related data sets and creating a Submissions Package output, including experience with Electronic Common Technical Documents [eCTD]) across Health Authorities.
  • Experience in GxP Document Content Management Applications used by Regulatory Operations.
  • Experience with IT Systems for product labeling according to the requirements in domestic and international standards and regulations.
  • Worked in enterprise wide implementation across multiple phases and workstreams (e.g. solution design and configuration, systems integration, data migration, validation, and training).
  • Knowledge on full life-cycle development: IND/NDA/BLA/MAA/CTA/510K Submission types dossiers including component such as CMC, IMPD and related amendments to support the solution design in accordance with the industry regulatory regulations.
  • Expertise in ICH-HL7 data standards of eCTD and IDMP, MedRA, CDISC controlled terminology and data governance, dictionary management for EDMS for Submission dossiers.

Quality Assurance:

  • Experience in implementation and management for pharmaceutical/biologics/medical devices Quality Systems and Quality Risk Management Solutions.
  • Direct experience with systems such as Veeva Vault, ETQ Reliance, Sparta TrackWise, OpenText, SharePoint, Master Control, Documentum D2, FirstDoc FirstPoint, NextDocs, UL ComplianceWire, and other quality information management or content management systems.
  • Led requirements workshops: design, prototype, configure, and document content management/QMS data solutions.
  • Managed and overseen day-to-day maintenance continuous improvement of Quality System IT Components, including but not necessarily limited to Deviation, CAPA, OOS, Complaint, and Change Control related technical solutions.
  • Supported the preparation, coordination, and management of regulatory agency Preapproval or regular inspections from IT perspective.
  • Worked closely with Business Stakeholders to ensure/coordinate appropriate and complete resolution of findings/non-compliant issues, quality investigations, etc. in a timely manner, including approval of corrective action and preventative action (CAPA) plans, as necessary.
  • Participated or Conducted in internal audits (systems, processes, vendors, computer system validation)
  • Provided IT expertise to investigation teams of quality management framework, controls, policies and procedures
  • Experience with Quality System investigations and other concepts (Deviation, OOS, Issue Management, CAPA, Change Control, Audits, etc.).
  • Must have working knowledge of FDA (21CFR 210, 211 & 820) and EU regulatory requirements.
  • Provided quality oversight and compliance support to implement and validate electronic systems in accordance with the corporate computer system validation (CSV) procedures and requirements.

Education Requirements:

Bachelor’s/Master’s degree in Life Sciences, Computer Engineering, Electrical Engineering, Computer Science, Information Technology, or equivalent experience of 10-12 years in IT technical role related to R&D, Regulatory Operations and Quality Assurance IT Systems is preferred. Certification with RAPS and or ASQ is plus.

WHY JOIN US?

We’re a network of entrepreneurial self-starters who contribute to something far bigger. There’s a diversity of expertise in our Technology group that’s unique to AstraZeneca – it allows us to dive deep into exploring new leading-edge technology. We enable AstraZeneca to perform at its peak by delivering world-class technology and data solutions. Our work unlocks the potential of science. We optimize and evolutionise AstraZeneca by maximizing efficiencies and finding new ways to drive productivity. From automation to data simplification. We’re not afraid to take ownership and run with it. Empowered with unrivalled freedom. A place to be open and transparent – we speak up, think creatively and share ideas. Our diverse contributions help us to make better decisions. But we have a constant drive to innovate, and an appreciation for high standards. It takes challenging the status quo to add value in our ever-evolving environment. We love it here because put simply, we make a meaningful impact.

Technology at AstraZeneca is a home for purposeful disruptors!

SO, WHAT’S NEXT?

Are you already imagining yourself joining our team? Good, because we’d love to hear from you! Click the link to apply and we’ll be in touch as soon as we can.

WHERE CAN I FIND OUT MORE?

Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/

Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/

Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en



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 authorisation and employment eligibility verification requirements.

50200081 F ITSE Operations

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