Pharmavise Corporation ยท 1 month ago
GxP Sr. Consultant / Subject Matter Expert - Life Sciences
United States
Contract
Remote
Senior Level, Lead/Staff
15+ years expPharmavise Corporation is seeking deeply experienced industry professionals for a remote consulting role. The ideal candidate will lead GxP-focused consulting engagements and provide expert guidance across various functions, ensuring compliance and optimizing Quality Management Systems.
Food and BeverageHealth Care
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
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
Qualification
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)
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
Preferred
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
Company
Pharmavise Corporation
โฆ๐๐ฑ๐๐๐ฅ๐ฅ๐๐ง๐๐ ๐ญ๐ก๐ซ๐จ๐ฎ๐ ๐ก ๐๐ฎ๐๐ฅ๐ข๐ญ๐ฒโฆ: ๐๐ก๐๐ซ๐ฆ๐๐ฏ๐ข๐ฌ๐, ๐ฒ๐จ๐ฎ๐ซ ๐ฌ๐ญ๐ซ๐๐ญ๐๐ ๐ข๐ ๐๐ข๐๐ ๐๐๐ข๐๐ง๐๐๐ฌ, ๐๐๐๐ฅ๐ญ๐ก๐๐๐ซ๐ ๐๐ง๐ ๐๐จ๐ฏ๐๐ซ๐ง๐ฆ๐๐ง๐ญ ๐ฌ๐จ๐ฅ๐ฎ๐ญ๐ข๐จ๐ง๐ฌ ๐ฉ๐๐ซ๐ญ๐ง๐๐ซ.
11-50 employees
Funding
Current Stage
Early StageTotal Funding
unknown2020-04-04Seed
Leadership Team
Ricardo Joseph
Founder and CEO
Company data provided by crunchbase