Business Analyst - Life Sciences (GxP Environment) Job at Sopra Steria (Machelen)

Pharmaceutical Business Analyst

Are you a detail-oriented professional with strong analytical skills and a passi...

Location

Canada , Toronto

Salary:

Not provided

Amaris Consulting

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Business, Life Sciences, Engineering, or related field
Proven experience as a Business Analyst in the pharmaceutical or biotech industry
Strong understanding of GxP, regulatory compliance, and pharmaceutical manufacturing processes
Experience working with ERP, MES, LIMS, or other life sciences digital systems
Excellent communication, documentation, and stakeholder management skills
Ability to work independently and collaboratively in a fast-paced environment

Job Responsibility

Gather, analyze, and document business requirements from stakeholders across departments
Translate business needs into functional specifications and user stories
Collaborate with cross-functional teams including IT, QA, Manufacturing, and Regulatory Affairs
Support system implementation and process improvement initiatives
Perform gap analysis and recommend solutions to enhance operational efficiency
Assist in validation documentation and ensure compliance with industry regulations (GxP, FDA, EMA)

What we offer

An international community bringing together more than 110 different nationalities
An environment where trust is central: 70% of our leaders started their careers at the entry level
A strong training system with our internal Academy and more than 250 modules available
A dynamic work environment that frequently comes together for internal events (afterworks, team buildings, etc.)

Fulltime

Regulatory Data & Systems Manager

The Regulatory Data & Systems Manager will be responsible for facilitating syste...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Strong interpersonal and teamwork skills, with the ability to interact with business users, technical IT groups, project managers, senior management, outsourced service providers, and vendors
5+ years' experience as a business analyst, with command of business analysis techniques & tools, as well as SDLC & agile systems development methodologies
Excellent oral and written communication skills
able to organize and present ideas in a convincing and compelling manner
Ability to operate effectively in a matrix environment
team player yet able to work independently with minimal direction
Familiarity with GxP requirements and systems validation
Life Sciences, Biotech or pharmaceutical industry experience preferred
Proven Veeva Vault knowledge
Bachelor’s degree and 2 years of directly related experience

Job Responsibility

System Administration: Manage and maintain the organization's IT systems, ensuring they are secure, efficient, and compliant with regulatory requirements
Regulatory Business Analysis: Interpret and implement regulatory requirements, ensuring all systems and processes adhere to relevant regulatory requirements and industry best practices
Project Coordination: Assist in planning, tracking, and executing departmental projects and initiatives
Stakeholder Communication: Liaise with internal and external stakeholders to ensure timely and accurate communication regarding regulatory requirements and system updates

What we offer

Reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment

New

Validation Engineer / Business Analyst

We are seeking a Validation Engineer / Business Analyst to support GxP-regulated...

Location

Salary:

Not provided

Numbers Only Inc

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Engineering, Life Sciences, or related field (Master’s preferred)
3+ years of experience in Medical Device/Pharma regulated environments
Hands-on experience in CSV/CSA and validation documentation
Familiarity with eQMS platforms (Veeva, ETQ, Arena or similar)
Strong knowledge of FDA regulations and ISO 13485

Job Responsibility

Execute validation lifecycle activities (VP, IQ/OQ/PQ, RTM, VSR/TSR)
Ensure compliance with FDA 21 CFR Part 11, Part 820, ISO 13485, and EU Annex 11
Gather and document business requirements
translate into testable system specifications
Support MES, eQMS, and Non-Product Software validation and change control
Maintain audit-ready documentation and support internal/external audits
Assist with CAPA, non-conformance, and risk management activities

Executive Director, Data & Technology Site & Study Startup Support

The Executive Director, D&T Site & Study Startup Support serves as the senior te...

Location

United States

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

15+ years of experience in clinical operations technology, Site & Study Startup processes, feasibility, regulatory workflows, or related domains
Experience implementing enterprise clinical systems and managing cross‑functional integrations
Proven ability leading global, matrixed technology or operational teams
Bachelor’s degree in Life Sciences, Engineering, Business, or related discipline required
Master’s degree or equivalent experience preferred
Deep knowledge of site and study startup processes (feasibility, submissions, activation, regulatory workflows)
Strong understanding of clinical operational systems and data flows
Expertise delivering technology solutions in regulated clinical research environments
Executive‑level communication, influence, and cross‑functional leadership
Ability to translate operational challenges into system and data improvements

Job Responsibility

Serve as the primary D&T executive partner for the global Site & Study Startup function, ensuring alignment to operational processes and startup lifecycle needs
Drive system enhancements that improve startup predictability, data capture, cycle times, and risk identification
Use innovative technology to improve effectiveness and efficiency of the business
Partner with business leaders to ensure systems availability and support for feasibility modeling, country and site selection, document collection and workflows, ICF customization, EC/RA/MoH submissions, SIV scheduling and activation readiness
Provide technology, analytical models, and data tools for feasibility assessments
Ensure real‑time access to feasibility insights, performance history, and site data across data platforms
Oversee integrations between Site & Study Startup systems and broader D&T ecosystem systems
Coordinate with regulatory and compliance technology partners to ensure consistent data flows
Ensure end‑to‑end system readiness and integration for regulatory document management, site regulatory package preparation, greenlight/activation processes, system setup and training workflows
Build and scale reporting capabilities that measure startup progress, activation risks, feasibility metrics, and regulatory timelines

What we offer

Health, Vision & Dental Insurance
Tuition Reimbursement
Vacation/Holiday/Sick Time
Flexible Spending & Health Savings Accounts
Work/Life Balance
401(k) with Company match
Pet Insurance
Opportunity to work on innovative projects at the forefront of the industry
Collaborative and inclusive work environment that values your expertise
Professional advancement and development opportunities

Specialist Software Development

As a Specialist at Amgen, you will be responsible for developing and maintaining...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Master's degree
OR Bachelor's degree and 8 - 12 years of Information Science experience
7+ years of direct experience with Biovia OneLab ELN, Thermo Fisher Sample Manager LIMS or comparable ELN solutions
Strong understanding of system ownership responsibilities including: GxP compliance, 21 CFR Part 11 requirements, and validation
System lifecycle management, change control, and audit readiness
Ensuring data integrity and security of scientific records
Proven experience integrating and validating systems within a regulated environment (GxP, FDA, EMA)
Experience with integrating OneLab ELN, LIMS into broader Operations, R&D and IT ecosystems
Familiarity with scientific workflows (biologics, chemistry, lab processes) and ability to translate them into digital solutions
Hands-on technical skills with SQL, Python, AWS, and APIs for data workflows, automation, and system integration

Job Responsibility

Design, develop, and maintain secure, scalable applications and integrations across QC and commercial platforms (AWS, Databricks, Salesforce Marketing Cloud, Mulesoft, LIMS, ELN, and CDS)
Serve as a system owner by managing lifecycle activities (configuration, validation, upgrades, change control, documentation, and audit readiness) in compliance with GxP and 21 CFR Part 11 requirements
Collaborate with business analysts, developers, and stakeholders to gather requirements, deliver validated solutions, and support Agile/DevOps practices
Champion continuous improvement by troubleshooting issues, optimizing workflows, and evaluating new platform capabilities to enhance business value and user experience
Serve as the System Owner for Quality Control Laboratory Platforms (Sample Manager LIMS, Biovia OneLab ELN) ensuring the platform is compliant, validated, secure, and aligned with regulatory requirements
Own the system lifecycle — oversee implementation, upgrades, validation, and retirement activities, following Amgen’s system development life cycle (SDLC) and change management processes
Act as the primary liaison between product team, support team and client facing technology leads
Collaborate closely with developers and technical teams to design, configure, integrate, and validate enhancements, extensions, and interfaces
Lead and coordinate validation activities, including authoring/reviewing test scripts, managing traceability matrices, and supporting audit readiness
Manage integrations and data workflows between OneLab ELN and supporting systems, ensuring seamless interoperability and secure data exchange

What we offer

Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan—comprising health, finance and wealth, work/life balance, and career benefits—with compensation and benefits rated above 4 stars (out of 5) on Glassdoor

New

Bilingual Customer Service Representative

We are looking for a Bilingual Customer Service Representative to join our clien...

Location

Canada , Montréal

Salary:

21.42 CAD / Hour

Randstad

Expiration Date

April 07, 2026

Requirements

3 years of experience supporting insurance programs
Fluency in French and English (oral and written)
Proficiency in Microsoft Office suite applications
Excellent communication skills, empathy, and proven ability to listen and serve
College diploma preferred, high school diploma required

Job Responsibility

Promptly and professionally answer incoming calls, chats, and inquiries
Develop product knowledge and effectively convey information to clients
Demonstrate active listening, clarify information, and de-escalate situations
Document customer inquiries and solutions
Maintain established performance levels
Understand and resolve compliance issues
Support teamwork
Effectively identify and respond to customer needs, providing solutions and alternatives

What we offer

Work from home

New

Truck driver

Randstad Transport is looking for English speaking truck drivers in the Netherla...

Location

Netherlands , 's-Hertogenbosch

Salary:

17.58 - 21.01 EUR / Hour

Randstad

Expiration Date

June 29, 2026

Requirements

CE-driving licence with valid Code 95
Digital tachograph card
Experience driving a trailer
Live in the Netherlands
Available during weekends
Flexible
Stress resistant
Representative
Physically fit

Job Responsibility

Distribution to supermarkets
Postal service
Driving between DC’s throughout the Netherlands
Work during the day and nighttime
Be available for work at least 2 out of 4 Saturdays
Drive on highways and in busy city centers

What we offer

Travel allowance
Modern and well maintained truck
25 holidays per year
Holiday allowance (8,33% of gross pay)
Personal assistance with work and career
Punctual and correct payment of salary and allowances

New

Office admin/executive assistant- future opportunities

JOIN OUR TALENT POOL OF ADMINISTRATIVE PROFESSIONALS. Do you have experience as ...

Location

Canada , Mississauga

Salary:

55000.00 - 90000.00 CAD / Year

Randstad

Expiration Date

April 06, 2026

Requirements

2 + years of administrative experience
Excellent communication, written and verbal
Proficient in Microsoft Office/Excel

Job Responsibility

Manage telephone system and handle all incoming and outgoing calls and emails
Act as the first point of contact for external clients and internal departments
Calendar management and scheduling
Appointment booking
Handle travel arrangements and intenerates
Meeting preparation
Recording meeting minutes
Invoicing and expense reports
Database management (electronic and paper)
Data entry

What we offer

Hear about new employment opportunities (contract, temporary and permanent)
Chat with recruiters who can connect you top employers
Gain market insight
Tips on how to leverage your skills in the current market

Fulltime

Business Analyst - Life Sciences (GxP Environment)

Sopra Steria

Location:
Belgium , Machelen

Category:
-

Contract Type:
Employment contract

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
April 25, 2025

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