CQ Manager - Drug Product

About No deviation

At No deviation, we are dedicated to delivering patient-centric solutions that revolutionize the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we are looking for individuals who are excited to contribute to impactful projects and drive innovation.

We believe that great things happen when Empathy, Integrity, and Transparency guide our actions. That's why we foster a culture of collaboration, inclusion, and continuous development - empowering our team members to grow personally and professionally.

Position Overview

We are seeking an experienced CQ Manager Drug Product to manage commissioning and qualification of our sterile fillfinish facility. You will be responsible for ensuring that aseptic manufacturing systems, isolators, packaging equipment, lyophilizers, and cleanroom environments meet GMP, Annex 1, and regulatory requirements. In this role, you will lead cross-functional teams, oversee protocol execution, troubleshoot technical challenges during startup, and maintain audit-ready documentation. Your work will directly support the manufacture of safe, high-quality drug products that reach patients worldwide.

Key Responsibilities

• Lead CQV activities for isolators, filling lines, lyophilizers, packaging and capping machines, compounding systems, and cleanrooms.
• Execute protocols and documentation (FAT/SAT, URS, IQ/OQ/PQ, cleaning validation support).
• Ensure equipment and processes meet GMP, Annex 1, and aseptic processing standards.
• Collaborate with Aseptic Operations, Engineering, QA, MSAT, and vendors.
• Resolve equipment issues during startup and ensure reliable batch execution.
• Drive risk assessments, deviation investigations, and change control.
• Support inspection readiness for regulatory agencies.

Required Qualifications

• Degree in Engineering, Pharmaceutical Sciences, or related field.
• 10+ years CQV experience in sterile fillfinish or aseptic manufacturing.
• Familiarity with isolator technology, lyophilization, and aseptic processing is required.
• Strong understanding of Annex 1 requirements.

Why join us

• Generous Leave Policy.
• Comprehensive Health & Wellness Coverage: Receive robust medical and dental coverage to support your health needs.
• Professional Development Opportunities: Access continuous learning programs and resources for career growth within the company.
• Inclusive Culture: Work in an environment where innovation, collaboration, and diverse perspectives are encouraged and celebrated.
• Shape the Future: Make a real difference in the pharmaceutical industry while advancing your career.

How to apply

Are you ready to play a key role in shaping the future of pharmaceutical solutions If you're passionate about making an impact, we want you on our team!

Please submit your resume, outlining your qualifications and experience relevant to the role, here.