Head of Quality
Metric Bio - Philadelphia
Work at Metric Bio
Overview
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Overview
Head of Quality
Company Overview :
Our client, a leading CDMO specializing in the development and manufacturing of small molecules in solid oral dosage forms, is seeking a Head of Quality to lead their quality assurance efforts. In their new CDMO site that is being built out for this industry leading organization. This is a key leadership position within the organization, responsible for ensuring that all products are manufactured in compliance with cGMP, regulatory requirements, and the highest quality standards as you will be the first hire for the site.
Position Overview :
The Head of QA will oversee all quality activities for the manufacturing and packaging of solid oral dosage forms. You will lead and mentor a team of quality professionals and work closely with cross-functional teams to ensure the successful commercialization of small molecule products. This role involves direct interaction with clients, regulatory agencies, and internal teams, ensuring that all aspects of quality assurance, compliance, and validation meet the highest standards.
Qualifications :
- Bachelor's degree in Life Sciences, Chemistry, or related field (advanced degree preferred).
- 10+ years of experience in the pharmaceutical or biotechnology industry, with at least 5 years in a leadership role focused on quality assurance in a CDMO environment.
- Start up/ department build out/ Scale Up experience
- Multi site oversight is a plus
- Vendor Qualification experience
- Extensive experience with cGMP, FDA, and EMA regulations for small molecule solid oral dosage forms.
- Proven track record of successful audits, regulatory inspections, and compliance management.
- Excellent leadership, communication, and interpersonal skills.