Manager – Regulatory & Quality Assurance Platforms –

Manager, Regulatory & Quality Assurance Platforms - (OFR0251)
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 lead 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 work 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:

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 standard methodologies 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 catalog 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 intuition for business 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.

Chips in 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 empower an agile and diverse team of authorities in a sophisticated matrix organization. This role is a mix of leading a team and establishing a relationship of trust with our partners, anchored by good technical and domain expertise and continuous learning and development.

Building strong strategic relationships with sophisticated 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 consensus from senior leaders for IT initiatives, demonstrating 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 chipping in 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 duplication or conflicting demands.

Operating: Execute on the platform roadmap, actively lead the platform as a set of interconnected assets and lead 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: someone who can understand the issues, the broader context, and help to develop strategic and specific solutions.

Technology Savvy: 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, establishing 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 sophisticated facilitation and dependency management techniques (cross team, cross department).

Led 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 confirmed, 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.

Led and supervised 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 proven understanding 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.