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

Specialist, GxP Compliance & Data Integrity

Beam is seeking a highly skilled Specialist I/II to join our growing Digital Qua...

Location

United States , RTP, North Carolina

Salary:

105000.00 - 145000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Engineering, Computer Science, Life Sciences, or a related field with 10+ years of relevant experience
or Master’s degree in the same fields with 8+ years of relevant experience
Experience working in Quality Assurance, Validation, or IT Quality Assurance roles within the biotechnology or pharmaceutical industry
Experience working with systems like DeltaV, OSI PI, BAS, Kneat, Veeva, MES or comparable automation and data systems
Familiarity working with manufacturing platforms such as Rotea, Sepax, LOVO, Cue, Prodigy, MaxCyte, Skid Controllers and platform integrations with DeltaV is preferred
Experience with analytical instruments such as Spectramax, Zetasizer, MACSQuant, SoloVPE, BacT with MYLA software, and other laboratory instruments
Experience with supplier management program for computerized system suppliers
Strong operational knowledge of risk-based tools, ALCOA+ principles, FDA and MHRA data integrity guidance, and 21 CFR Part 11/Annex 11 regulations is preferred
Prior experience working as a QA reviewer for embedded computerized systems – manufacturing equipment(s) and analytical instruments
Proven ability to implement cross-functional remediation plans aligned with the regulatory expectations for CSV/CSA and data governance

Job Responsibility

Oversee risk-based Computerized System Validation (CSV)/Computerized Software Assurance (CSA) activities across Manufacturing, QC, IT, Automation and Global Platforms, ensuring 21 CFR Part 11/Annex 11 and Beam’s internal policies and procedures
Support review and approval of validation lifecycle documents including but not limited to SIA, URS/SRS, CS, FDS, IQ, OQ, PQ, RTM and VSR, for embedded computerized systems and global platforms
Support authoring of CSV lifecycle and test documents, risk assessments and gap assessments as required
Collaborate with IT system owners, business systems owners, validation and product quality to deploy robust data integrity controls across systems and processes
Participate in Change Management activities to ensure controlled evaluation, qualification, and deployment of changes
Serve as SME and/or Quality approver on QMS records including change controls, continuous improvements, CAPAs, deviations and supplier qualification associated with computerized systems and data integrity
Review and ensure validation compliance for infrastructure systems such as DeltaV, MES, OSI PI, BAS, Clinical and Cloud systems
Act as data integrity SME by ensuring the enforcement of ALCOA+ principles and identifying critical data risks across manufacturing processes, QC methods, and computerized systems
Actively participate in the development of data integrity gap assessment program and assessment tools and eventual gap remediation activities by supporting identification of short term and long term mitigation strategies
Contribute to improvements in CSV/CSA and data integrity policies and procedures, user/functional group SME training and guidance

Fulltime

IT Project Manager - ELN Platforms (Electronic Lab Notebook) & Scientific Data Systems

The IT Project Manager – ELN, Scientific Data Platforms & Manufacturing Systems ...

Location

India , Hyderabad

Salary:

Not provided

NTT DATA

Expiration Date

Until further notice

Requirements

10-15+ years in IT delivery with program-level ownership
8+ years delivering ELN or scientific data platforms in regulated environments
5+ years of MES implementation or integration experience (e.g., batch execution, eBR)
5-8 years of GxP validation (CSV/CSA) ownership across lab and/or manufacturing systems
5+ years driving adoption across scientific and/or manufacturing organizations
5+ years integrating ELN with LIMS/CDS/SDMS AND/OR MES with lab systems
Proven decision-making authority (not support roles)
Notice Period: 30 Days

Job Responsibility

Lead full lifecycle: strategy → design → configuration → integration → validation → deployment → adoption → optimization
Own delivery across lab systems and manufacturing platforms (MES)
Align scientific data strategy with manufacturing execution and batch data flows
Deliver against measurable outcomes: Adoption, Data quality, Compliance, Cycle time
Translate experimental workflows (R&D, QC) and manufacturing processes into structured digital systems
Standardize experiment design (ELN) and batch records & execution workflows (MES)
Ensure traceability from development → production
Own CSV/CSA validation strategy across ELN, MES, integrated lab/manufacturing systems
Ensure compliance with GxP, 21 CFR Part 11, ALCOA+ principles
Accountable for audit readiness and validation documentation completeness

Fulltime

Associate Scientist II, R&D, Complex Product Development

This is where new knowledge is discovered. Baxter's Research and Development tea...

Location

India , Ahmedabad

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Master's in science with 8 to 12 years of Experience
Good experience in the execution of analytical method development, validation and technology transfer and routine analysis for peptides and iron colloidal drug products for regulatory submission
Competency with method relevant to iron DS/DP analysis, including particle size distribution by gel filtration chromatography, light scattering/diffraction/obscuration methods, assay of various iron forms, e.g. ferrous, ferric, labile iron, chelation assays, reduction potential and kinetics, etc, is strongly desired
Basic Knowledge and execution of Chemical Analysis using techniques relevant to complex injectables
Knowledge of pharmacopoeia, ICH Guidelines
Execution of Operational and Calibration of Instrument on periodic basis
Trouble shooting of various problems obtain during the during analysis
Knowledge of Transfer of Technology
Knowledge of Good Laboratory Practice and Good Documentation Practices
Communication skills

Job Responsibility

To plan and perform sample analysis (analytical method development, validation, technology transfer, etc) activity following GxP & GDP practices for regulatory submissions for complex injectables like peptides, iron formulations, etc
Assist in regulatory query responses for Complex Products
To perform testing of Complex Injectable samples, including, API, development, validation, stability, bulk hold, RLD, PDR and any other samples as required, according to appropriate method of analysis
To be competent in analytical problem-solving, focus on innovation, process improvement and operational excellence
To keep track of all activities related to product analysis, ensure completion in the stipulated time, and inform the Sub-department manager if any deviation or issues observed
Preparation and review of analytical reports, SOPs and MOAs by referring to GQP & current pharmacopoeia as per requirement
To carry out all testing and data recording according to the approved SOPs following GDP & ALCOA++ principles and current pharmacopoeia
To use appropriate reference and working standards for analysis and maintain their records
To complete all training as per the quality matrix targets
To perform or review the calibration records of instruments as per approved SOPs

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Fulltime

Senior Director, R&D GxP Audit

The Senior Director, R&D GxP Audit will lead the global strategy, execution, and...

Location

United States

Salary:

199782.30 - 270293.70 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 5 years of experience in Quality Assurance or Strategy in a regulated industry OR Master's degree and 9 years of experience in Quality Assurance or Strategy in a regulated industry OR Bachelor's degree and 11 years of experience in Quality Assurance or Strategy in a regulated industry
at least 5 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources

Job Responsibility

Develop and execute a global, risk-based GxP audit strategy aligned to quality and portfolio priorities
Lead internal, external, and supplier audit programs across R&D and supporting functions
Serve as a strategic advisor to the Head of R&D Quality on compliance trends, systemic risks, and assurance strategies
Build and lead a high-performing audit organization with strong technical and leadership capability
Oversee audits of clinical trial processes, pharmacovigilance systems, laboratories, quality systems, and supporting functions
Ensure audits assess both compliance to regulations and effectiveness of quality management systems
Drive consistency in audit methodology, planning, execution, reporting, and follow-up globally
Evaluate third-party quality systems, regulatory history, data integrity controls, and operational capability
Support qualification, ongoing oversight, escalation, and remediation of critical suppliers
Use quality risk management principles and data analytics to prioritize audits based on business criticality, compliance history, inspection outcomes, and emerging risks

What we offer

A 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
Flexible work models where possible

Fulltime

Territory Account Manager

The Territory Account Manager role is responsible for driving growth by leveragi...

Location

United States , Evans

Salary:

Not provided

ATS Automation Tooling Systems Inc.

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Business, Life Sciences, Marketing, or a related field
or equivalent combination of education and relevant experience
2-5+ years of sales experience in Life Sciences, including pharmaceutical, biotechnology, medical device, diagnostics, or laboratory solutions (level adjustable based on role seniority)
2+ years of channel, partner, or indirect sales experience, with demonstrated success managing distributor, reseller, or strategic partner relationships preferred
Proven track record of meeting or exceeding revenue targets through partner-led or hybrid (direct + channel) sales models
Experience supporting complex, consultative sales cycles, including multi-stakeholder decision-making and longer buying timelines
Working knowledge of Life Sciences regulatory and compliance environments (e.g., FDA, GxP, quality systems, data integrity expectations)
Demonstrated ability to build and execute joint business plans, pipeline development strategies, and partner enablement programs
Experience collaborating cross-functionally with marketing, product management, operations, and direct sales teams
Proficiency with CRM systems (e.g., Salesforce or equivalent), pipeline forecasting, and performance reporting

Job Responsibility

Meet and exceed all sales plans/ targets Develop, manage, and grow strategic relationships with authorized channel partners supporting the Life Sciences Channel portfolio
Drive bookings growth by executing partner-led sales strategies aligned to target customers and market segments
Enable channel partners through training, joint business planning, sales enablement tools, and product education to ensure effective market execution
Collaborate closely with channel sales teams to coordinate go-to-market initiatives, pipeline development, and account coverage
Support and execute tabletop events at key channel partners customer sites to drive product awareness and generate qualified leads
Maintain and manage demo units and sample inventory, ensuring timely availability for customer visits, trials and channel partner support
Identify new channel opportunities and recruit, onboard, and ramp qualified partners to expand market coverage and customer reach
Prospect and develop new customer relationships through cold calling, email outreach, networking, and client referrals
Expand business within the assigned territory by identifying opportunities, understanding customer needs, and presenting tailored solutions
Conduct in-person and virtual meetings, product demonstrations, and consultations

What we offer

Life, Health, Dental, Vision
401(K) including company match
Paid Time Off annually + Paid Holidays
Career Advancement Opportunities
Tuition Assistance

Fulltime

R&D Sterility Assurance - Project Lead

This is where your work makes a difference. At Baxter, we believe every person—r...

Location

Belgium , Braine-l'Alleud

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

B.S. in Engineering with 5–8 years of experience, or M.S. with 2–4 years, or Ph.D. with 1–2 years of relevant industry experience
Strong understanding of engineering principles and cross‑disciplinary collaboration
Knowledge of sterilization modalities (Moist Heat, EtO, Radiation, Aseptic Processing preferred)
Experience in GMP environments and with regulatory expectations for sterile products
Ability to design experiments, analyze data, and draw meaningful conclusions
Analytical, structured problem‑solver with strong decision‑making abilities
Clear, confident communicator able to influence stakeholders and management
Able to work independently in ambiguous environments while balancing quality and business needs
Proven ability to mentor and support junior colleagues
Willingness to travel up to 20%

Job Responsibility

Act as the Sterility Assurance Project Lead / Focal Point for R&D programs
Define and execute sterility assurance strategies, including test method validation plans, rationale statements, and sterilization parameters
Provide interpretation and guidance on GxP and global sterility regulations
Support regulatory submissions related to sterility assurance
Lead sterility assurance activities with a high degree of autonomy across projects of broad scope
Contribute to project planning, budgets, product requirements, and design decisions
Communicate status, risks, and recommendations to cross‑functional teams and leadership
Serve as a technical liaison with manufacturing facilities (domestic and international)
Evaluate and adapt sterilization approaches to optimize quality, safety, and cycle time
Support microbiology test method validations

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Fulltime

Executive Director, Quality Data Analytics and Process Management

In this vital role as the Executive Director, R&D Quality Data Analytics & Proce...

Location

United States , Thousand Oaks

Salary:

241843.70 - 327200.30 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 6 years of pharmaceutical/biotech quality systems, clinical quality, R&D operations, analytics, or process management
Master's degree and 10 years of pharmaceutical/biotech quality systems, clinical quality, R&D operations, analytics, or process management
Bachelor's degree and 12 years of pharmaceutical/biotech quality systems, clinical quality, R&D operations, analytics, or process management
6 years of managerial experience directly leading people in a multi-tiered organization and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Job Responsibility

Develop and execute a multi-year strategy for process management, data analytics, document management, and risk management aligned to R&D Quality priorities
Serve as a strategic advisor to the Head of R&D Quality on process performance, clinical quality trends, operational risk, and digital opportunities
Build a high-performing organization focused on innovation, simplification, and measurable business impact
Act as business process owner for core R&D Quality processes such as deviations/nonconformances, CAPA, change control, training (metrics) and risk management
Support the R&D business process owners to develop global standards, process controls, KPIs, roles/responsibilities, and governance for assigned processes
Ensure simplification, standardization, and modernization of document structures and approval workflows in partnership with Global Quality
Ensure processes are compliant with applicable GxP regulations and integrated across functional boundaries
Lead periodic process reviews, health checks, and continuous improvement initiatives related to these processes
Establish a modern analytics strategy for R&D Quality using dashboards, predictive indicators, trend analysis, and self-service reporting tools
Develop executive dashboards for quality performance, compliance health, process efficiency, inspection readiness, and risk visibility

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 where possible

Fulltime

Project Manager/RTE & Scrum Master - AI-Driven Clinical Data Management

We are looking for a pragmatic, hands-on servant leader who thrives in ambiguity...

Location

Switzerland , Basel

Salary:

Not provided

Randstad

Expiration Date

July 31, 2026

Requirements

7+ years of project management experience in software delivery, including 3+ years managing programmes with multiple parallel teams
Demonstrated Scrum Master experience - you have facilitated agile teams, not just observed them. You know how to run an effective retro and how to coach without directing
Pharmaceutical or Life Sciences industry experience with understanding of GxP requirements and what inspection readiness means in practice
Hands-on Jira experience - you have configured and managed Jira projects, not just consumed reports. Xray test management experience preferred
Experience with scaled agile delivery (SAFe or similar) and the pragmatism to know when to adapt the framework to the situation
Strong risk and dependency management skills with a bias toward action
Experience managing distributed hybrid teams across multiple time zones
Fluent English communication - written and verbal

Job Responsibility

Programme Delivery Management: Own the delivery plan across multiple parallel teams from current state through MVP and subsequent releases
Drive PI-level planning, manage cross-team dependencies, and resolve blockers before they hit the critical path
Maintain the RAID log with clear owners, deadlines, and recommendations
Enforce scope discipline through a structured requirements intake and triage process
Release management: develop and maintain a release calendar and schedule, coordinating with development, QA, and operations teams on timelines. Lead post-implementation reviews to identify release cycle process improvements
Scrum Master for Three Delivery Teams: Facilitate sprint planning, daily standups, reviews, and retrospectives for the teams
Shield teams from external disruptions and remove impediments quickly
Coach team members on agile practices and continuous improvement
Track sprint health (velocity, burndown, blocked items) and surface concerns early
Support Product Owners with backlog refinement, story breakdown, and Definition of Done compliance

Fulltime

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Data Program Manager - GxP Experience

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