Pharmavise Corporation
GxP Sr. Consultant / Subject Matter Experts - Trusted Partner Network
Be an Early Applicant
Lead GxP-focused consulting projects, develop and optimize Quality Management Systems, support compliance readiness, mentor junior members, and provide expert regulatory advice.
This is a remote position.
We are seeking deeply experienced industry professionals with strong technical judgment, hands-on expertise, and a proven record of delivering high-impact consulting projects.
Ideal consultants are seasoned practitioners with 15+ years of experience and domain depth in GxP operations, regulatory compliance, quality systems, validation, engineering, and/or clinical operations.
Key Responsibilities- Lead and deliver GxP-focused consulting engagements, serving as an SME across multiple functions such as Quality, Regulatory, Manufacturing, Engineering, and Clinical Operations.
- Develop, review, and optimize Quality Management Systems (QMS) and regulatory frameworks aligned with applicable global standards (FDA, ISO, ICH, EU MDR, MHRA, Health Canada, etc.).
- Provide expert guidance on compliance readiness, remediation, and responses to regulatory inspections (FDA 483s, Warning Letters, audit observations).
- Design, execute, and oversee validation and qualification programs:
- Process validation
- Equipment qualification (IQ/OQ/PQ)
- Software/CSV (21 CFR Part 11)
- Cleaning and sterilization validation
- Computerized systems validation
- Process validation
- Support product development programs, ensuring adherence to design control, risk management, verification/validation, and DHF/technical documentation requirements.
- Perform gap assessments, root cause investigations, and CAPA development to address quality and compliance risks.
- Serve as an advisor to executive teams and technical leads on regulatory pathways, submission strategies, and lifecycle management.
- Provide project leadership and mentoring to junior team members, ensuring structured execution and high-quality deliverables.
- Prepare and deliver client-facing reports, technical documentation, strategic recommendations, and training.
- Support change management, technology transfer, and scale-up initiatives for manufacturing and operations.
- Travel to client sites as needed for assessments, workshops, audits, and project execution.
Required
- 15+ years of progressively responsible experience in GxP environments within pharma, biotech, medical devices, or life sciences manufacturing.
- Recognized subject matter expertise in at least one of the following domains:
- Quality Assurance / Quality Systems
- Regulatory Affairs
- Validation & Engineering (Process, Equipment, Automation, CSV)
- Manufacturing Operations / Tech Transfer
- Clinical Operations & Compliance
- Risk Management (ISO 14971)
- Design Controls (21 CFR 820, ISO 13485)
- Quality Assurance / Quality Systems
- Strong working knowledge of global GxP regulations and standards (FDA 21 CFR, EU MDR/IVDR, ISO 13485, ICH Q-series, GAMP 5, ISO 9001/62304/17025, etc.).
- Proven ability to lead cross-functional projects and serve as a senior advisor for complex technical challenges.
- Prior experience in consulting, advisory, or client-facing technical leadership roles.
- Excellent communication, documentation, and presentation skills.
- Advanced degree in Life Sciences, Engineering, Quality, Regulatory, or related field.
- Previous work with both large multinational organizations and small/emerging companies.
- Experience navigating regulatory submissions (510(k), PMA, NDA, BLA, IND, Technical Files).
- Professional certifications such as:
- ASQ (CQE, CQA, CMQ/OE)
- RAC (Regulatory Affairs Certification)
- PMP
- Six Sigma Green/Black Belt
- ASQ (CQE, CQA, CMQ/OE)
This is a consulting/contract-based role. Engagements vary by project and may include:
- Full-time project support
- Part-time advisory
- Fixed deliverable-based engagements
- Remote, hybrid, or on-site work depending on client needs
Similar Jobs
Cloud • Security • Software • Cybersecurity • Automation
Serve as a strategic People Business Partner to senior Product and Marketing leaders, designing and executing talent, performance, succession, and organizational strategies. Drive workforce planning, calibrations, promotions, and compensation reviews; partner with TA, Rewards, and Development; surface people analytics to inform leadership decisions; support globally distributed teams and navigate change with both strategic guidance and hands-on execution.
Big Data • Cloud • Software • Database
Lead go-to-market positioning and messaging for MongoDB's Public Sector vertical (focusing on federal/FedRAMP High), create sales enablement and customer-facing content, partner cross-functionally with compliance, product, sales, and partners, run competitive and win/loss analysis, and expand the narrative to SLED in Phase 2.
Top Skills:
AWSCio-Sp3CmmcDocument DatabaseDod Impact LevelsFedramp HighGCPGsa SchedulesGsa SewpIntegrated AiItarAzureMongoDBMongodb AtlasSearchStaterampStream ProcessingVector Search
Edtech • Healthtech • HR Tech • Information Technology • Professional Services • Software • Telehealth
Sell Rethink Ed solutions to K-12 districts across a multi-state territory. Prospect and develop new business, manage the full sales cycle, engage senior district leaders, maintain an accurate Salesforce pipeline, execute territory plans, deliver presentations, and meet assigned sales quotas while expanding Rethink's footprint.
Top Skills:
Salesforce
What you need to know about the San Francisco Tech Scene
San Francisco and the surrounding Bay Area attracts more startup funding than any other region in the world. Home to Stanford University and UC Berkeley, leading VC firms and several of the world’s most valuable companies, the Bay Area is the place to go for anyone looking to make it big in the tech industry. That said, San Francisco has a lot to offer beyond technology thanks to a thriving art and music scene, excellent food and a short drive to several of the country’s most beautiful recreational areas.
Key Facts About San Francisco Tech
- Number of Tech Workers: 365,500; 13.9% of overall workforce (2024 CompTIA survey)
- Major Tech Employers: Google, Apple, Salesforce, Meta
- Key Industries: Artificial intelligence, cloud computing, fintech, consumer technology, software
- Funding Landscape: $50.5 billion in venture capital funding in 2024 (Pitchbook)
- Notable Investors: Sequoia Capital, Andreessen Horowitz, Bessemer Venture Partners, Greylock Partners, Khosla Ventures, Kleiner Perkins
- Research Centers and Universities: Stanford University; University of California, Berkeley; University of San Francisco; Santa Clara University; Ames Research Center; Center for AI Safety; California Institute for Regenerative Medicine
