Job Description
Freyr Digital — a technology-driven company building smart, AI-powered software solutions for the Life Sciences industry, including pharmaceuticals, biotech, and healthcare.
As part of Freyr Solutions, a global leader with over a decade of regulatory expertise, Freyr Digital is revolutionizing traditional processes through cutting-edge digital innovation. By leveraging AI, automation, and cloud-based platforms, we make compliance and regulatory operations faster, more intelligent, and effortlessly scalable for our 200+ global clients across multiple countries.
Website Link: & Delivery Leadership:
Ability to manage large, multi-region, multi-technology implementation programs with structured governance.
Regulatory Domain Expertise: Strong functional knowledge of RIMS, e CTD submissions, Labeling, Artwork, and regulatory operations.
Technical Implementation Experience: Hands-on familiarity with Veeva Vault, CARA, ECM platforms, upgrades, re-engineering, and data migrations.
Compliance & Validation: Expertise with ERES, ANNEX 11, 21 CFR Part 11, and validated system documentation.
SOW & Financial Governance: Strong command of estimations, ROMs, SOW creation, pricing models, vendor oversight, and profitability management.
Cross-Functional Influence: Ability to collaborate with Product, Engineering, Sales, and SMEs to align delivery with strategic objectives.
Risk & Escalation Management: Proactively identify risks, maintain mitigation plans, and engage leadership at the right time.
Team Leadership: Experience managing global teams and scaling capabilities in high-complexity environments
Implementation Leadership & Governance:
Lead all implementation programs across products, regulatory platforms, upgrades, data migrations, and custom IT solutions.
Establish delivery governance frameworks, execution models (Agile/Hybrid), and milestone-based tracking to ensure predictable outcomes.
Maintain strict implementation discipline across scope, timelines, quality, compliance, and stakeholder alignment.
Oversee validated system implementations adhering to ERES, ANNEX 11, and 21 CFR Part 11. Professional Services Operations & Profitability
Run Professional Services as a profitable practice with ownership of utilization, margins, and delivery efficiency.
Govern T&M, Fixed Bid, and Transaction-based pricing models; lead SOW/ROM creation, estimations, and contractual compliance.
Standardize templates, processes, accelerators, and best practices for repeatable, scalable service delivery. Customer Success During Implementations
Lead executive-level engagement for implementation programs ensuring transparency, risk mitigation, and expectation management.
Conduct global workshops, requirements alignment sessions, UAT planning, and go-live orchestration.
Ensure seamless handovers to post-go-live support and Customer Success teams. Cross-Functional Collaboration
Partner with Product & Engineering to align implementation planning with product roadmaps, release cycles, and platform capabilities.
Collaborate with Sales for pre-sales discovery, estimation, and solutioning for strategic opportunities (while ensuring PS is not a sales support function). Head of Professional Services (Implementation)
Engage Domain Excellence teams to ensure regulatory workflows, compliance requirements, and functional design are executed with accuracy. Vendor & Partner Management
Manage vendor engagements including capability assessment, price negotiation, delivery oversight, and risk management.
Ensure external partners adhere to Freyr’s quality, compliance, and delivery standards. Global Team Leadership
Lead and expand global implementation teams across PMO, Technical Consultants, Functional experts, Migration teams, and Validation specialists.
Build delivery capability for regulatory platforms such as Veeva Vault, CARA, RIMS, e CTD, and enterprise technologies (Open Text-ECM, SAP,. NET, Java, mobile).
Foster a culture of accountability, clarity, governance discipline, and customer-centric delivery.
As part of Freyr Solutions, a global leader with over a decade of regulatory expertise, Freyr Digital is revolutionizing traditional processes through cutting-edge digital innovation. By leveraging AI, automation, and cloud-based platforms, we make compliance and regulatory operations faster, more intelligent, and effortlessly scalable for our 200+ global clients across multiple countries.
Website Link: & Delivery Leadership:
Ability to manage large, multi-region, multi-technology implementation programs with structured governance.
Regulatory Domain Expertise: Strong functional knowledge of RIMS, e CTD submissions, Labeling, Artwork, and regulatory operations.
Technical Implementation Experience: Hands-on familiarity with Veeva Vault, CARA, ECM platforms, upgrades, re-engineering, and data migrations.
Compliance & Validation: Expertise with ERES, ANNEX 11, 21 CFR Part 11, and validated system documentation.
SOW & Financial Governance: Strong command of estimations, ROMs, SOW creation, pricing models, vendor oversight, and profitability management.
Cross-Functional Influence: Ability to collaborate with Product, Engineering, Sales, and SMEs to align delivery with strategic objectives.
Risk & Escalation Management: Proactively identify risks, maintain mitigation plans, and engage leadership at the right time.
Team Leadership: Experience managing global teams and scaling capabilities in high-complexity environments
Implementation Leadership & Governance:
Lead all implementation programs across products, regulatory platforms, upgrades, data migrations, and custom IT solutions.
Establish delivery governance frameworks, execution models (Agile/Hybrid), and milestone-based tracking to ensure predictable outcomes.
Maintain strict implementation discipline across scope, timelines, quality, compliance, and stakeholder alignment.
Oversee validated system implementations adhering to ERES, ANNEX 11, and 21 CFR Part 11. Professional Services Operations & Profitability
Run Professional Services as a profitable practice with ownership of utilization, margins, and delivery efficiency.
Govern T&M, Fixed Bid, and Transaction-based pricing models; lead SOW/ROM creation, estimations, and contractual compliance.
Standardize templates, processes, accelerators, and best practices for repeatable, scalable service delivery. Customer Success During Implementations
Lead executive-level engagement for implementation programs ensuring transparency, risk mitigation, and expectation management.
Conduct global workshops, requirements alignment sessions, UAT planning, and go-live orchestration.
Ensure seamless handovers to post-go-live support and Customer Success teams. Cross-Functional Collaboration
Partner with Product & Engineering to align implementation planning with product roadmaps, release cycles, and platform capabilities.
Collaborate with Sales for pre-sales discovery, estimation, and solutioning for strategic opportunities (while ensuring PS is not a sales support function). Head of Professional Services (Implementation)
Engage Domain Excellence teams to ensure regulatory workflows, compliance requirements, and functional design are executed with accuracy. Vendor & Partner Management
Manage vendor engagements including capability assessment, price negotiation, delivery oversight, and risk management.
Ensure external partners adhere to Freyr’s quality, compliance, and delivery standards. Global Team Leadership
Lead and expand global implementation teams across PMO, Technical Consultants, Functional experts, Migration teams, and Validation specialists.
Build delivery capability for regulatory platforms such as Veeva Vault, CARA, RIMS, e CTD, and enterprise technologies (Open Text-ECM, SAP,. NET, Java, mobile).
Foster a culture of accountability, clarity, governance discipline, and customer-centric delivery.
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