Senior External Clinical Supply Quality Lead

Johnson & Johnson Innovative Medicine

Gierle

Sur place

EUR 73 000 - 115 000

Plein temps

Il y a 4 jours

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Résumé du poste

Johnson & Johnson Innovative Medicine is seeking a Sr Analyst, External Clinical Supply Quality, to drive QA for external manufacturers involved in packaging, labeling, and distribution of Investigational Medicinal Products. You will lead audits, manage quality agreements, and ensure cGMP compliance across suppliers.

Beerse, Belgium; Cork, Ireland; Latina, Italy offer multi-site locations with travel up to 10–15%.

Qualifications

Bachelor's degree in science, engineering or technical field.
Minimum 6 years in Pharmaceuticals or equivalent regulated environment.
Minimum 4 years in Quality or Compliance preferred.
Excellent verbal and written communication with internal/external customers.
Ability to work independently and meet tight deadlines.
Strong knowledge of cGMP, FDA/EMEA regulations.
Experience leading external supplier audits.
Fluent in written and spoken English.

Responsabilités

Serve as QA contact for External Manufacturer/Supplier with signatory authority.
Lead qualification during supplier selection and audits.
Negotiate and approve Quality Agreements with external manufacturers.
Develop and implement quality systems to support external suppliers.
Provide cGMP compliance support and investigate quality issues.
Monitor KPIs and manage batch record review with cross-functional teams.
Ensure regulatory documents are reviewed and commitments tracked.
Stay current with GMP regulations and company policies.