Industry Solutions Specialist - Pharma & Biotech

ComplianceQuest; United States; Remote; USD 120,000 - 170,000; Full time

Job summary

ComplianceQuest is seeking an Industry Solutions Specialist & Market Advocate – Pharma/Biotech. You will own the pharma/biotech industry solution, align it with clinical operations, manufacturing, quality, and regulatory workflows, and drive enterprise adoption across R&D, regulatory, and GMP contexts.

You will engage with executives and industry groups, translating market insights into product strategy while advancing post‑sales adoption and supporting regulatory readiness and inspections.

Qualifications

• Proven ability to bridge enterprise sales, product strategy, and customer success in life sciences SaaS.
• Strong understanding of GxP workflows, clinical development, regulatory compliance.
• Experience presenting to executives in biopharma and regulatory forums.

Responsibilities

• Own Pharma/Biotech industry solution definition, positioning, and evolution across R&D, clinical, quality, regulatory, manufacturing.
• Support pre-sales with subject matter expertise in clinical trial workflows, GMP operations, digital quality systems, CSV, and enterprise SaaS architecture.
• Advise executives on Pharma/Biotech regulations including FDA 21 CFR 11, EU Annex 11, ICH guidelines.
• Represent company at industry events and build thought leadership on digital GxP transformation and data integrity.

Skills

Enterprise sales

Product strategy

Customer success

Communication

Leadership in biopharma forums

Education

Bachelor’s degree or higher in Life Sciences/Pharmaceutical Sciences/Regulatory Affairs/Engineering/CS

Master’s degree preferred

Tools

Enterprise SaaS architecture

Regulatory frameworks

Job description

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%

Why ComplianceQuest:

ComplianceQuest is the fastest-growing, 100% modern cloud, AI-powered platform for Product Lifecycle, Quality, and Safety Management, built natively on the Salesforce platform. Our next-generation solutions help organizations of all sizes deliver high-quality products and services—safely, efficiently, and sustainably.

As a fully remote company with a global team of 180+ professionals, we empower our customers to mitigate risks, resolve issues proactively, and drive continuous improvement—while protecting their people, products, suppliers, and brands.

At ComplianceQuest, we thrive on innovation, collaboration, and impact. We're always looking for passionate, forward-thinking professionals to join our growing team and help shape the future of quality and compliance.