Industry Solutions Specialist – Pharma & Biotech

Industry Solutions Specialist – Pharma & Biotech Job details

Marketing / Industry Solutions Remote-USAFull-time
** Join the team that's transforming compliance and quality for the modern enterprise.
** The
** Industry Solutions Specialist & Market Advocate – Pharma/Biotech
** is responsible for owning and advancing the company’s end‐to‐end industry solution for
** pharmaceutical, biotechnology, clinical development, and GMP-regulated manufacturing organizations**. This role supports enterprise sales engagements, drives strategic post‐sales adoption, represents the company across
** R&D, clinical, regulatory, quality, and manufacturing forums**, and converts market intelligence into actionable product strategy.

This position focuses on
** Pharmaceutical**,
** Biotechnology**,
** CRO/CDMO**,
** Clinical Research**,
** Drug Development**, and
** GMP/GCP‐regulated manufacturing environments**, helping customers maximize value from the company’s SaaS platform by aligning
** quality, compliance, data integrity, clinical, manufacturing, and regulatory workflows
** across the entire product lifecycle.

The Specialist acts as the connector between customers, the biopharma market, and internal teams—leveraging deep expertise in
** GxP compliance, drug development processes, clinical operations, CMC, digital quality systems, regulatory frameworks, and enterprise SaaS**.
** Responsibilities and Duties
**** 1. Industry Solution Ownership & Enterprise Solutions Management
*** Own the definition, positioning, and evolution of the company’s
** Pharma/Biotech industry solution
** as a targeted, repeatable offering across R&D, clinical, quality, regulatory, and manufacturing operations.
* Support pre‐sales activities with subject matter expertise in
** clinical trial workflows, GMP operations, digital quality systems, CMC, regulatory intelligence, data integrity, and enterprise SaaS architecture**.
* Advise executives on aligning platform capabilities with key
** Pharma/Biotech regulations**, including:
* ** FDA 21 CFR Part 11**,
** Part 210/211**,
** Part 312**,
** Part 314**
* ** EU Annex 11**,
** Eudra Lex Volume 4**
* ** ICH Q7–Q12**,
** ICH E6 R2/R3**,
** ICH M2**
* ** GxP** (GMP, GCP, GLP)
* ** Data integrity frameworks (ALCOA+)
*** Develop and maintain demo environments and proof‐of‐concept assets aligned with
** clinical operations, manufacturing, quality management, regulatory submissions, inspections, and product lifecycle workflows**.
* Support enterprise-level solution discussions across global biopharma organizations with complex
** regulatory, integration, validation, multi-site, and data governance requirements**.
** 2. Customer Lifecycle Management
*** Collaborate with Customer Success and Professional Services to define new workflows, integrations, and automation opportunities across
** clinical research, regulatory operations, QA/QC, manufacturing, product release, validation, and safety/PV functions**.
* Conduct quarterly and annual business reviews with
** Quality, Regulatory, R&D, and Clinical leadership**, presenting measurable ROI, compliance improvements, operational KPIs, inspection-readiness progress, and systemic risk reduction.
* Identify, assess, and mitigate risks related to
** regulatory exposure, audit/inspection gaps, scalability, enterprise adoption, data integrity, validation**, and long‐term retention for complex global biopharma customers.
** 3. Industry Evangelism and Advocacy
*** Represent the company at
** bio‐pharmaceutical, clinical research, regulatory science, digital quality, and GMP/GCP industry events**, trade shows, webinars, and forums.
* Support creation of thought leadership, including case studies, industry benchmarks, whitepapers, and best‐practice guides on
** digital GxP…