GxP Sr. Consultant / Subject Matter Experts - Trusted Partner Network

Talanto; Northern (KY); Hybrid; USD 160,000 - 210,000; Full time

Job summary

Talanto is seeking a deeply experienced GxP Senior Consultant to deliver high-impact engagements across Quality, Regulatory, Manufacturing, Engineering and Clinical Operations. The role emphasizes regulatory readiness, validation programs, lifecycle management, and advisory support to executive teams.

Remote work with client-site as needed; requires 15+ years in pharma/biotech/life sciences. The position offers flexibility across full-time project work, advisory engagements, or fixed

Qualifications

• 15+ years of progressively responsible experience in GxP environments within pharma, biotech, medical devices, or life sciences manufacturing.
• Subject matter expertise in Quality Assurance / Quality Systems, Regulatory Affairs, Validation & Engineering, or Manufacturing Operations / Tech Transfer.
• Proven ability to lead cross-functional projects and act 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.

Responsibilities

• Lead and deliver GxP-focused consulting engagements across Quality, Regulatory, Manufacturing, Engineering, and Clinical Operations.
• Develop, review, and optimize QMS and regulatory frameworks aligned with global standards (FDA, ISO, ICH, EU MDR, MHRA, Health Canada).
• Provide guidance on compliance readiness, remediation, and responses to regulatory inspections (FDA 483s, Warning Letters).
• Design, execute, and oversee validation and qualification programs (process, equipment IQ/OQ/PQ, CSV, cleaning, sterilization).
• Support product development programs ensuring design control, risk management, verification/validation, and DHF documentation.
• Perform gap assessments, root cause investigations, and CAPA development.
• Advise executive teams on regulatory pathways, submission strategies, and lifecycle management.
• Provide project leadership and mentorship to junior team members; deliver client-facing reports and training.
• Support change management, technology transfer, and scale-up for manufacturing and operations.

Skills

GxP compliance

Regulatory affairs

Quality systems

Consulting leadership

Communication skills

Education

Advanced degree in Life Sciences or Engineering

Job description

GxP Sr. Consultant / Subject Matter Experts - Trusted Partner Network

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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
• 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.

Qualifications

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

Engagement Type

• Full-time project support
• Part-time advisory
• Fixed deliverable-based engagements
• Remote, hybrid, or on-site work depending on client needs