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GxP Senior Consultant – Subject Matter Expert, Life Sciences

March 7, 2026

Job Description: • 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. Requirements: • 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. Benefits: • Health insurance • Departmental retreats • Flexible working hours • Professional development opportunities Apply tot his job

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Common Interview Questions And Answers

1. HOW DO YOU PLAN YOUR DAY?

This is what this question poses: When do you focus and start working seriously? What are the hours you work optimally? Are you a night owl? A morning bird? Remote teams can be made up of people working on different shifts and around the world, so you won't necessarily be stuck in the 9-5 schedule if it's not for you...

2. HOW DO YOU USE THE DIFFERENT COMMUNICATION TOOLS IN DIFFERENT SITUATIONS?

When you're working on a remote team, there's no way to chat in the hallway between meetings or catch up on the latest project during an office carpool. Therefore, virtual communication will be absolutely essential to get your work done...

3. WHAT IS "WORKING REMOTE" REALLY FOR YOU?

Many people want to work remotely because of the flexibility it allows. You can work anywhere and at any time of the day...

4. WHAT DO YOU NEED IN YOUR PHYSICAL WORKSPACE TO SUCCEED IN YOUR WORK?

With this question, companies are looking to see what equipment they may need to provide you with and to verify how aware you are of what remote working could mean for you physically and logistically...

5. HOW DO YOU PROCESS INFORMATION?

Several years ago, I was working in a team to plan a big event. My supervisor made us all work as a team before the big day. One of our activities has been to find out how each of us processes information...

6. HOW DO YOU MANAGE THE CALENDAR AND THE PROGRAM? WHICH APPLICATIONS / SYSTEM DO YOU USE?

Or you may receive even more specific questions, such as: What's on your calendar? Do you plan blocks of time to do certain types of work? Do you have an open calendar that everyone can see?...

7. HOW DO YOU ORGANIZE FILES, LINKS, AND TABS ON YOUR COMPUTER?

Just like your schedule, how you track files and other information is very important. After all, everything is digital!...

8. HOW TO PRIORITIZE WORK?

The day I watched Marie Forleo's film separating the important from the urgent, my life changed. Not all remote jobs start fast, but most of them are...

9. HOW DO YOU PREPARE FOR A MEETING AND PREPARE A MEETING? WHAT DO YOU SEE HAPPENING DURING THE MEETING?

Just as communication is essential when working remotely, so is organization. Because you won't have those opportunities in the elevator or a casual conversation in the lunchroom, you should take advantage of the little time you have in a video or phone conference...

10. HOW DO YOU USE TECHNOLOGY ON A DAILY BASIS, IN YOUR WORK AND FOR YOUR PLEASURE?

This is a great question because it shows your comfort level with technology, which is very important for a remote worker because you will be working with technology over time...