Industry Solutions Specialist – Pharma & Biotech

PLP Group; Northern (KY); Hybrid; USD 120,000 - 180,000; Full time

Job summary

PLP Group is seeking an Industry Solutions Specialist & Market Advocate – Pharma/Biotech to own the end-to-end industry solution for pharmaceutical, biotech, CRO/CDMO, and GMP-regulated environments. You will partner with enterprise sales, customer success, and product teams to advance post-sales adoption and align platform capabilities with global regulations.

The role focuses on FDA/ICH/GxP-driven workflows, data integrity, and digital quality systems across R&D, manufacturing, and regulatory

Qualifications

• Experience bridging sales, product strategy, and customer success in life sciences SaaS.
• Knowledge of GMP/GxP, regulatory compliance, and drug development.
• Proven ability to engage executives and cross-functional teams.
• Experience with industry advocacy and thought leadership.

Responsibilities

• Own Pharma/Biotech industry solution design and roadmap.
• Support pre-sales with SME in clinical and GMP workflows.
• Represent the company at biopharma industry events.
• Translate market needs into product requirements for end-to-end drug development.

Skills

GxP workflows

Clinical operations

Regulatory compliance

Drug development

Stakeholder communication

Pharma/Biotech domain

Education

Bachelor’s degree in Life Sciences or related field

Master’s degree preferred

Tools

CSV/GAMP 5

Enterprise SaaS platforms

Job description

Industry Solutions Specialist – Pharma & BiotechJob detailsMarketing / Industry SolutionsRemote-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**, **EudraLex 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 transformation, inspection readiness, data integrity maturity, AI‐enabled analytics, and digital quality/QMS excellence**.* Build and maintain relationships with organizations such as **ISPE, DIA, BIO, PDA, PhRMA, regulatory intelligence groups**, and leading clinical/manufacturing networks to stay ahead of emerging trends.* Provide structured reporting to senior leadership on customer engagement trends, competitive insights, and industry advocacy initiatives.* Maintain deep awareness of evolving **GMP/GCP/GLP standards, CMC requirements, computerized system validation (CSV/GAMP 5), cybersecurity frameworks (NIST/ISO), AI and automation trends, and digital clinical technologies**.**4. Cross-Functional Product Alignment*** Serve as the primary liaison between **biopharma customers**, market stakeholders, and internal product teams.* Translate customer and market needs into requirements and user stories for capabilities spanning **clinical workflows, regulatory submissions, batch record processes, deviation/CAPA management, validation documentation, CMC change control, manufacturing quality, and safety/PV intelligence**.* Evaluate market research and usage analytics to identify opportunities for new product features supporting **end‐to‐end drug development and commercial manufacturing**.* Partner with Product Management to ensure pharma/biotech requirements influence strategic roadmap planning.* Educate Sales, Marketing, and Customer Success teams on **pharma-specific value propositions**, use cases, and competitive differentiators.* Ensure all solutions adhere to **GxP regulations**, internal quality systems, validation standards, and information security requirements.**Qualifications****Knowledge, Skills, and Abilities Required*** Proven ability to bridge enterprise sales, product strategy, and customer success in a **pharma, biotech, clinical research, GMP manufacturing, or life sciences SaaS environment**.* Strong understanding of **GxP workflows**, clinical trial operations, CMC, pharmaceutical manufacturing, and regulatory compliance frameworks.* Demonstrated expertise in industry solution design, competitive positioning, and enterprise-level differentiation in the **drug development ecosystem**.* Exceptional communication skills with the ability to engage **scientific, clinical, regulatory, quality, manufacturing, IT, and executive audiences**.* Proven leadership representing a technology company in high‐visibility **biopharma and regulatory forums**.**Education & Experience Requirements*** Bachelor’s degree or higher in **Life Sciences, Biotechnology, Pharmaceutical Sciences, Biomedical Engineering, Chemical Engineering, Regulatory Affairs, Informatics, Computer Science, Business**, or related field.* Master’s degree in science, engineering, business, or informatics is preferred.* Minimum **5 years of experience** in product management, solutions engineering, industry advocacy, or related leadership roles within **Pharma, Biotech, Clinical Research, CDMO/CRO, or GxP SaaS platforms**.**Work Environment & Conditions*** Standard 40‐hour workweek with flexibility for extended hours during key customer engagements or industry events.* Domestic and international travel to **biopharma manufacturing sites, research centers, clinical hubs, regulatory meetings, and industry conferences**.* Ability to work in office or remote environments while complying with company IT security, quality, validation, and safety standards.* Ability to travel 25%