Senior Quality Consultant – Person-in-Plant

This is a fully remote position, open to applicants in United Kingdom, +4 more countries.

📋 Description

• Oversee and lead routine Quality Management Reviews (QMRs).

• Offer quality oversight and assistance during Process Performance Qualification (PPQ) activities for clinical and commercial products.

• Conduct essential audits related to quality findings.

• Organize and facilitate mock inspection readiness activities, which include preparation, coaching, documentation reviews, and inspection simulations.

• Execute QMS tasks, including CAPAs and deviations.

• Aid inspection and audit readiness efforts across clinical and commercial manufacturing operations.

• Work collaboratively with cross-functional stakeholders to identify and mitigate quality risks.

• Assess and review quality systems, documentation, and manufacturing processes to ensure compliance with GMP and company quality standards.

• Serve as a quality subject matter expert for assigned projects and quality-related initiatives.

• Offer guidance on compliance expectations and quality system requirements.

• Provide comprehensive QA Lead support for Person-In-Plant activities.

⛳️ Requirements

• A Bachelor's degree or higher in a life sciences discipline is mandatory.

• Extensive experience in Quality Assurance within the life sciences sector.

• Prior experience as a Person-in-Plant or in supporting Person-in-Plant activities is essential.

• Previous experience managing CDMO partners is highly preferred.

• Proficiency in English is required.

• Must currently reside in the UK or EU.

• Capability to execute the project as specified in the job description.

🏝️ Benefits

• Initial short-term project lasting three months.

• Full-time commitment of 1.0 FTE (40 hours per week).

• Support for remote working arrangements.

• Hybrid working is encouraged for new hires who are within a reasonable commuting distance from an office, as agreed upon with the manager.

• An Equal Opportunity Employer dedicated to fostering diversity, equity, and inclusion in the workplace.