Project Lead - GXP Software

Key responsibilities
Project leadership and delivery
Define the project charter, objectives, scope, deliverables, governance,
milestones, resource plan, budget, and measures of success.
Lead implementation through the appropriate delivery lifecycle, coordinating
discovery, design, configuration or development, testing, deployment, and
transition to operations.
Maintain an integrated project plan and manage dependencies, risks, issues,
decisions, assumptions, and changes.
Facilitate timely decisions; escalate material risks and delivery constraints
with clear options and recommendations.
Provide concise, accurate status reporting to project governance and
stakeholders.
Coordinate internal teams, implementation partners, and software vendors,
clarifying accountabilities and deliverables across organizational boundaries.

GxP quality and compliance
Integrate applicable GxP, quality-system, data-integrity, privacy,
cybersecurity, and records-management requirements into project planning
and solution delivery.
Partner with process owners, system owners, Quality, validation, security,
privacy, architecture, and operations representatives to establish the required
compliance approach.
Ensure that intended use, user and system requirements, risk assessments,
traceability, testing evidence, and release documentation are developed and
maintained as appropriate to the system and its risk.
Coordinate validation or other documented assurance activities in line with
applicable procedures and the agreed risk-based approach.
Support controlled configuration and change management, including
assessment of changes that could affect validated state or regulated
processes.
Ensure readiness for deployment, including training, procedures, support
model, data migration where applicable, and transition into a controlled
operating environment.
Promote inspection readiness through complete, consistent, and retrievable
project documentation; support audits or inspections as requested.
Stakeholder engagement and change adoption
Translate R&D business and user needs into clear scope, outcomes, and
prioritized requirements with accountable stakeholders.
Build alignment across global and local teams, including users, product or
process owners, technical teams, and quality partners.
Communicate project impacts, decisions, risks, and readiness expectations in
a timely and audience-appropriate way.
Coordinate change-impact assessment, stakeholder engagement,
communications, and role-based training with the relevant change and
business leads.
Gather feedback and support a smooth handover so that the solution can be
sustainably operated and continuously improved.
Required qualifications and experience
Bachelor s degree or equivalent practical experience in information
technology, engineering, life sciences, business, or a related discipline.

Demonstrated experience leading complex software implementation or
transformation projects, preferably in a regulated life-sciences,
pharmaceutical, biotechnology, medical-device, or comparable environment.
Practical understanding of GxP computerized systems and the quality
practices used to deliver and maintain them, including risk assessment,
documented requirements, testing, change control, and lifecycle
documentation.
Experience coordinating multidisciplinary teams and external suppliers, with
accountability for scope, schedule, budget, risks, and delivery outcomes.
Strong stakeholder-management, facilitation, written communication, and
presentation skills.
Ability to make complex work understandable, bring structure to ambiguity,
and maintain delivery momentum while protecting quality and compliance.
Proficiency with common project planning, collaboration, and reporting tools.
Professional fluency in English; additional languages may be beneficial
depending on the project s stakeholder and user community.
Preferred qualifications and experience
Experience implementing software that supports R&D processes, such as
laboratory, clinical, scientific-data, quality, or research information systems.
Relevant project-management training or certification, or demonstrated
equivalent experience.
Familiarity with agile, waterfall, or hybrid delivery approaches and the ability
to select practices appropriate to project risk and context.
Experience with system integration, data migration, SaaS or cloud delivery,
supplier oversight, or global rollouts.
Experience supporting computer-system validation or risk-based assurance
activities in collaboration with Quality and system owners.
Understanding of data integrity principles and the controls needed to support
reliable, attributable, and traceable records.
Capabilities for success
Accountable delivery: Turns objectives into a realistic plan and follows
through on commitments.
Quality-minded judgment: Treats compliance and patient- and product-
relevant risk as integral to delivery, not as a final checkpoint.
Influence without authority: Builds trust and alignment across functions,
regions, and partner organizations.

Clear communication: Makes progress, trade-offs, and decisions visible
without obscuring important detail.
Pragmatic problem-solving: Resolves obstacles with proportionate,
evidence-based actions and escalates when needed.
User-centered change leadership: Keeps the intended users and
operational context in view from requirements through adoption.
Continuous improvement: Captures lessons learned and applies them to
improve delivery and operational readiness.