Archived listing. The details below describe a past opening.
Senior Quality Specialist
About the Position
We are seeking an experienced Senior Quality Specialist to oversee and support the company’s Quality Management System (QMS) and Quality Assurance operations. Reporting directly to the Head of Quality, this role is responsible for ensuring compliance with cGMP, regulatory requirements, and internal quality standards while driving continuous improvement initiatives across the organization.
The ideal candidate is a hands-on quality professional with experience in pharmaceutical, biotechnology, CDMO, or other regulated environments.
Key Responsibilities
- Lead the development, implementation, and continuous improvement of the company’s Quality Management System (QMS).
- Oversee the creation, approval, distribution, control, and archival of cGMP documentation, including:
- SOPs, Technical reports, Batch records, Training records, Logbooks
- Controlled quality documentation
- Manage document control processes, including document change requests, revision control, approval workflows, and employee training.
- Administer and maintain the company’s training program, including:
- New employee onboarding, Annual GMP training, Refresher training
- Job-specific training curricula, Training compliance records
- Review scientific documentation, including stability studies, method validation reports, and investigation reports.
- Lead internal quality audits and support customer and regulatory inspections.
- Prepare audit reports, coordinate responses, and oversee CAPA.
- Investigate deviations, nonconformances, and Out-of-Specification (OOS) results and ensure timely resolution.
- Develop and monitor quality metrics to evaluate QMS performance and identify opportunities for continuous improvement.
- Ensure compliance with FDA, ICH, and applicable cGMP regulations.
- Provide Quality Assurance oversight for laboratory and manufacturing activities.
Qualifications
- Bachelor’s or Master’s degree in Chemistry, Microbiology, Pharmaceutical Sciences, Biology, or a related scientific discipline.
- Minimum of 5 years of Quality Assurance experience within the pharmaceutical, biotechnology, CDMO, or other regulated industry.
- Strong knowledge of cGMP regulations, FDA quality requirements, Good Documentation Practices (GDP), and Pharmaceutical Quality Systems.
- Experience with:
- Document Control, CAPA, Change Control, Deviations
- OOS investigations, Internal audits, Training management
- Strong technical writing and documentation skills.
- Proficiency with Microsoft Office and electronic eQMS.
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