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

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 experiencein 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 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

Originally posted on Himalayas