Data Program Manager - GxP Experience Job at NTT DATA (Toronto)

New

Data Architect

Do you want to join a fast-growing global consultancy in the life science indust...

Location

Denmark , København

Salary:

Not provided

Life Science Talent

Expiration Date

Until further notice

Requirements

5+ years of experience in implementing IT solutions
3+ years in the pharmaceutical or life sciences industry
Experience building Data Architecture frameworks for a specific tech/data product
Experience designing and managing systems that integrate data from various sources (Mulesoft, Alteryx, Rest APIs)
Experience leading initiatives to establish robust data governance framework and lineage (GxP, 21 CFR Part 11)
Experience overseeing the continuous improvement of defined frameworks
Experience contributing to the identification of significant data assets & translation of business requirements into data products
Experience identifying & assessing potential impacts/opportunities of product choices from a data architecture standpoint
Experience coordinating with other Data/Tech Architects
Ability to provide data architecture best practices

Job Responsibility

Design and implement scalable data architectures to support the complex data needs of pharmaceutical clients
Lead the strategy for data integration, data governance, and cloud infrastructure across R&D and Commercial Excellence datasets
Ensure architecture aligns with industry standards and supports the team’s analytical objectives
Collaborate with senior stakeholders, business analysts, data engineers, and data scientists to create a unified, efficient data ecosystem
Translate pharma clients’ business needs into user stories and technology
Participate in implementation projects for high profile clients – from initiation to completion

What we offer

Flexible schedule
An entrepreneurial and multi-cultural work environment
Ongoing learning and development opportunities
An inspiring work environment with many social events
A culture based on trust, diversity, and inclusion
Home office setup and a remote friendly mindset
Comprehensive benefit package
Opportunities for career advancement
Competitive salary

Fulltime

New

Data Program Manager - GxP Experience

The Data Program Manager role requires a minimum of 8 years of project managemen...

Location

United States , Pittsburgh

Salary:

78948.00 - 164476.00 USD / Year

NTT DATA

Expiration Date

Until further notice

Requirements

8+ years of prior project management experience is essential
5+ years of healthcare domain experience
8+ years demonstrated familiarity with the application of project management principles, along with strong and proven coordination and project management abilities
5+ years of Application development project management experience
Bachelor’s degree or equivalent professional experience is required
CSM or SaFE Agile certification is preferred
PMP certification is desirable
Exceptional organizational skills and keen attention to detail are required
Strong interpersonal skills, as well as effective written and verbal communication abilities, are essential
Ability to prioritize tasks and perform successfully under tight deadlines is necessary

Job Responsibility

Project Delivery and Management
Ensure that all project deliveries are complete and accepted by the customer
Define, approve, manage, and control the scope of the project to meet customer expectations
Develop and manage project schedules to ensure on-time delivery
Estimate and manage project costs to deliver within the customer-approved budget, while preserving profit margins
Assign and manage resources effectively and efficiently to support project goals
Risk and Quality Management
Identify and manage risks and issues proactively throughout the project lifecycle
Plan and deliver high-quality results that meet all agreed-upon requirements, ensuring high customer satisfaction through effective management of the overall customer experience
Stakeholder Engagement and Communication

Fulltime

Senior Manager Global Category-Digital Health and Regulated Tech

We are seeking an individual who thrives in ambiguity, capable of driving catego...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Familiarity with procurement platforms such as Ariba, as well as ERP systems and advanced analytics tools
Excellent problem solving and organizational skills
Strong analytical skills, including the ability to analyze large datasets, identify trends, and derive actionable insights
Experience leading large, cross-functional teams and managing complex global projects in a matrixed environment
Strong knowledge of regulated software and digital health procurement
Familiarity with compliance frameworks (21 CFR Part 11, GxP, HIPAA, GDPR)
Experience with vendors in clinical technology, digital health, and connected medical solutions
Doctorate degree and 5 years of Global Strategic Sourcing, Procurement experience
Or Master’s degree and 12 years of Global Strategic Sourcing, Procurement experience
Or Bachelor’s degree and 15 years of Global Strategic Sourcing, Procurement experience

Job Responsibility

Lead category management for Digital Health and regulated technology software supporting clinical trials, patient engagement, and regulated applications
Partner with R&D, Clinical, Regulatory, and Compliance teams to ensure alignment with FDA, EMA, HIPAA, and GDPR standards
Negotiate contracts with vendors of e-clinical, ePRO, EDC, and patient-facing apps, balancing innovation with compliance
Build governance frameworks ensuring cybersecurity, data privacy, and quality system compliance for regulated digital solutions
Monitor evolving digital health regulations and integrate compliance into sourcing strategies
Provide strategic oversight as the lead for Digital Health and Regulated Software category and sourcing
Act as a trusted advisor to ensure that procurement initiatives are aligned with broader organizational objectives
Guide and facilitate collaboration across cross-functional teams and regional stakeholders
Ensure that all Software procurement activities are managed in compliance with regulatory, contractual, and operational risk requirements
Collaborate with Strategic Sourcing peers to oversee the strategic approach to complex negotiations for Software contracts

New

Executive Director – AIN Technology Lead for Enterprise Resource Planning (ERP)

Amgen India will be an integral part in driving growth & innovation, improving e...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

25+ years of extensive ERP leadership experience, including multiple SAP S/4HANA implementations, BTP, and RISE/Cloud ERP operations
Advanced program management expertise delivering complex, multi-year ERP programs
Experience in a global ERP environment and a commitment to continuous improvement of the ‘Run’ management
Strong experience in transformation, vendor management, and financial governance
Knowledge of ERP architecture, integration, and technology trends to drive innovation
Experience in biotechnology or pharmaceutical industry
Familiarity with SOX, GxP, and data protection regulations
Global leadership experience in shared services or digital hubs
Project Management Professional (PMP) (Preferred)
SAP Certification (Preferred): Certifications in SAP, particularly related to SAP S/4HANA

Job Responsibility

ERP Strategy Development: Define and lead Amgen’s global ERP vision, ensuring alignment with business growth, innovation, and digital strategy
Project and Program Management: Oversee delivery of a global ERP portfolio, ensuring business outcomes, scalability, and continuous improvement
Stakeholder Collaboration: Partner with global functional leaders (Finance, HR, Supply Chain, Commercial, Manufacturing) to optimize processes and enable digital transformation
Executive Engagement: Engage with executive leadership to communicate program outcomes, progress, and ROI in clear, actionable terms
ERP Implementation and Maintenance: Ensure ERP investments deliver measurable value through efficiency, compliance, and data-driven decision-making
Team Leadership and Development: Manage, mentor, coach and develop a large (up to 200 people) and diverse team of Technology professionals, fostering a collaborative and growth-oriented environment
Innovation and Technology Integration: Foster a culture of innovation, agility, and continuous improvement within the ERP organization and across the EP&P Teams

Sr Associate, AIN Learning and Performance

In this vital site enablement role you will be reporting to the Senior Manager, ...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Master's degree
Bachelor's degree and 2 years of Talent, Learning and Development, or Instructional Design experience
Associate's degree and 6 years of Talent, Learning and Development, or Instructional Design experience
Experience supporting training programs, content management, or learner support
Ability to work within established processes and support enhancements to learning workflows
Familiarity with learning methodologies, adult learning principles, or enterprise learning tools (e.g., LMS, LXP)
Experience with Learning Management Systems (e.g., Saba, Cornerstone) or content platforms
Experience in regulated environments (GxP, pharma, biotech) or training compliance support
Familiarity with project coordination for learning initiatives
Exposure to instructional design processes, even if not designing full curricula

Job Responsibility

Learning Program Execution & Coordination
Content & Data Management
Learning Analytics & Reporting
Stakeholder & Customer Support
Process & Quality Improvement
Collaboration & Cross-Functional Working
Guidance to Others

What we offer

Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible

New

Manager, Biospecimen Data Operations

Accountable for end-to-end biospecimen operational delivery across study lifecyc...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree
OR Master’s degree & 3 years of experience in supplier management at sponsor or supplier leadership at the vendor
OR Bachelor’s degree & 5 years of experience in supplier management at sponsor or supplier leadership at the vendor
OR Associate’s degree and 10 years of experience in supplier management at sponsor or supplier leadership at the vendor
Strong project management experience
Fluency in English, both in written and oral communication
Excellent user of Office Programs such as Excel, Word, Powerpoint
Scientific or drug development technical expertise supporting Research, Development, Medical, Global Regulatory, Global Safety or Knowledge Management

Job Responsibility

Accountable for end-to-end biospecimen operational delivery across study lifecycle (start-up through database lock and archive)
Accountable for LIMS study build governance, integration integrity, and controlled data transfers
Accountable for reconciliation rigor, discrepancy resolution standards, and shipment readiness controls
Accountable for final results release governance, data management export validation, and database lock readiness
Accountable for inspection readiness, audit trail completeness, and quality event/CAPA integration into study operations
Accountable for Back Office Study Health oversight, operational risk visibility, and SLA-based escalation model
Accountable for vendor performance governance (central labs, analytical labs, biobank partners)
Accountable for automation adoption, reporting validation standards, and change control lifecycle oversight
Accountable for master data governance (tests, analytes, mapping standards, templates, version control)
Accountable for talent management, workload prioritization (~multi-study portfolio), and capability scaling within India hub

Software Validation Engineer

Master Compliance, Inc. in Irving, TX is seeking Software Validation Engineer(s)...

Location

United States , Irving

Salary:

Not provided

Master Compliance Inc

Expiration Date

Until further notice

Requirements

Master’s degree in Information Systems Technologies, Computer Science, or any related field of study and 1-year of experience in the job offered or in any related position(s) in which the required experience was gained
Demonstrable proficiency, skill, experience, and knowledge with Regulatory Compliance: FDA 21 CFR Part 11 and GxP guidelines
Demonstrable proficiency, skill, experience, and knowledge with Create and maintain validation documentation, including validation plans, protocols, and reports
Demonstrable proficiency, skill, experience, and knowledge with Conduct risk assessments to identify and mitigate potential compliance and system risks
Demonstrable proficiency, skill, experience, and knowledge with Good Documentation Practices (GDP) principles for maintaining accurate and organized records
Demonstrable proficiency, skill, experience, and knowledge with Software testing methodologies and experience in executing validation tests (IQ, OQ, PQ)
Demonstrable proficiency, skill, experience, and knowledge with Change control processes to manage modifications to validated systems
Demonstrable proficiency, skill, experience, and knowledge with Validation tools and software for data integrity and system validation
Demonstrable proficiency, skill, experience, and knowledge with IT and system architecture to understand and validate computerized systems
Demonstrable proficiency, skill, experience, and knowledge with Communication as liaise with cross-functional teams, vendors, and regulatory authorities

Job Responsibility

Design or plan protocols for equipment or processes to produce products meeting internal and external purity, safety, and quality requirements
Develop validation strategy for manufacturing equipment and lab equipment such as chromatography systems, burst testers, leak testers, freezers, Kaye validators, and building automation systems
Closely work with suppliers in qualification of manufacturing and lab equipment according to client policies and procedures
Develop User Requirements, System Requirements including system flow diagram Specifications, Configuration and Design Specifications
Develop test strategy and test plan for all validation testing activities (OQ, PQ and Pre-validation UAT protocols)
Author, review, and execute Validation Plan, Design Review, IQ Protocol/ Report, OQ Protocol/Report, PQ Protocol/Report, test cases, test incidents, trace matrix, change controls and validation report
Execute validation test protocols and document the test results
Develop defect reports and track them for its resolution and maintain Requirements Traceability Matrix (RTM) and prepare test summary report to summarize all the test activities including any open deviations
Provide guidance on business process improvements to follow lean manufacturing methodology
Track and monitor review and approval of validation deliverables, participate in meetings with project team and client stakeholders as required

Fulltime

Senior Technology Quality Auditor

Technology Auditors possess significant authority and decision-making power with...

Location

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

At least 5 years’ experience in regulatory affairs, clinical research, monitoring, data management, safety / pharmacovigilance, pharmacy, laboratory, or other relevant area in life science such as technology, third party supplier management
Minimum of 2 years' experience in quality assurance, auditing, including sound experience of applicable GxP technology auditing
Excellent knowledge, understanding and experience of Good Practices (GxPs) and international, national and local regulations and laws related to clinical trials and other clinical research
Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification or clinical research experience
Master’s degree in a science, technology or industry related discipline, preferred.

Job Responsibility

Independently lead, plan, schedule, perform, and report a range of technology audits across all phases of Clinical Research which may include but are not limited to project related audits, system and process audits, supplier qualification and re-qualification audits in order to evaluate the quality system against the appropriate regulatory requirements, relevant procedures and applicable guidelines
Perform and deliver high quality audits / audit reports within specified timelines / budgets, independently or with limited oversight
Ability to review and, if necessary, identify improvements that enhance the quality and clarity of audit reports
Travel internationally for audits, as required
Collect and review responses to audit findings and follow-up / escalate inadequate or delayed responses as necessary to ensure timelines are met and responses of satisfactory quality are obtained and formally recorded
Act as point of consultancy for Operations and Quality with regards to the implementation of adequate CAPAs with effective and timely escalation of relevant Quality Events where required
Coordinate internal global process / system audits across regions and develop all necessary tools such as report templates, checklists and standard emails
Ensure required audits are performed and reported in accordance with Parexel QA requirements, and on time
Review audit reports, responses and other program deliverable to ensure consistent high quality
Maintain required QA tools and ensure Parexel and QA systems are regularly updated with accurate information for audits and other activities

Data Program Manager - GxP Experience

NTT DATA

Location:
Canada , Toronto

Category:
IT - Administration

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
March 19, 2026

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