Senior GxP Consultant & SME - Life Sciences (Remote)

Pharmavise Corporation; Poland; Remote; PLN 300,000 - 420,000; Full time

Job summary

Pharmavise Corporation is seeking deeply experienced GxP consultants for remote engagement on complex compliance projects. The role demands hands-on judgment, 15+ years of domain depth in GxP operations, regulatory compliance, quality systems, validation, engineering, or clinical operations.

Ideal candidates will lead multi-function engagements, shape QMS and regulatory frameworks, and guide readiness for FDA, EU MDR, ISO standards with strong client-facing delivery and mentoring of junior staff.

Qualifications

• 15+ years of progressively responsible experience in GxP environments within pharma, biotech, medical devices, or life sciences manufacturing.
• Recognized subject matter expertise in Quality Assurance, Regulatory Affairs, Manufacturing Operations/Tech Transfer, Clinical Operations & Compliance, or Design Controls.
• 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).
• 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 Quality Management Systems (QMS) and regulatory frameworks aligned with applicable global standards (FDA, ISO, ICH, EU MDR, MHRA, Health Canada).
• 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, 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.

Skills

GxP expertise

Quality Assurance

Regulatory Affairs

Manufacturing Operations

Clinical Operations

Design Controls

Education

Advanced degree in Life Sciences / Engineering / Regulatory

Job description

Pharmavise Corporation is seeking deeply experienced GxP consultants for remote engagement on complex compliance projects. The role demands hands-on judgment, 15+ years of domain depth in GxP operations, regulatory compliance, quality systems, validation, engineering, or clinical operations.

Ideal candidates will lead multi-function engagements, shape QMS and regulatory frameworks, and guide readiness for FDA, EU MDR, ISO standards with strong client-facing delivery and mentoring of junior staff.