Job Title: Pharmaceutical Quality Assurance Manager
About the Role:
The Program Manager, Qualification & Validation is a critical position responsible for leading the qualification and validation activities necessary to bring newly built pharmaceutical manufacturing facilities into commercial operation.
Key Responsibilities:
* Provide project management approach that facilitates the execution of facility, equipment, and utility qualification (IQ/OQ/PQ) in accordance with GMP and regulatory expectations.
* Ensure facility readiness for regulatory inspections and approvals, including FDA, EMA, and other health authority requirements.
* Align efforts across Engineering, Validation, Manufacturing, Quality, and Supply Chain to ensure a seamless transition into commercial operations.
* Identify potential qualification and validation risks and proactively develop mitigation strategies with relevant stakeholders to keep the project on track.
Requirements:
* Bachelor's or Masters in Engineering (Mechanical, Chemical, Biomedical, Industrial, or related field).
* PMP, Six Sigma Black Belt, Lean Manufacturing certified preferred.
* Strong understanding of Annex I, US, and EMA GMP regulations, with practical experience in regulatory audits.
* Minimum 5 - 8 years of experience in pharmaceutical facility qualification, validation, or technical operations.
* Demonstrated ability to plan, design and manage significant NPI and Tech Transfer projects.
* Strong problem solving and critical thinking skills.
* Excellent communication, writing, presentation and data organisation skills.
* Demonstrated interpersonal and leadership qualities.