Supplier audits in cGMP supporting Biotech/pharma industries are highly preferred.
Supplier Quality Senior Engineer provides supplier oversight to ensure that suppliers of services or materials to Fujifilm Diosynth Biotechnologies are of the highest quality while conforming to pre-established requirements including cGMPs. This role primarily focuses on supplier quality, working with suppliers to maintain supplier approvals. Initially, this position will be key to the establishing the Supplier Quality System including but not limited to SOP and Specification development, Quality Agreements, Risk Assessments, Supplier Auditing and Supplier Change Notifications. The ability to effectively collaborate, influence, and coordinate amongst suppliers and team members within Supply Chain, Quality Control, and Quality Management is critical to this role.
About the Role
- Prepares, conducts, and reports results of audits of GMP service providers and suppliers of various GMP materials, and internal processes to meet quality compliance requirements.
- Creates and maintains a list of approved suppliers/service providers.
- Establishes and maintain policies, procedures, checklists, self-assessment surveys, and additional forms for the internal and supplier audit programs.
- Monitors raw material supplier quality and works directly with Supply Chain, QA, and suppliers to improve performance.
- Oversees and reports on the progress of audit corrective and preventative actions and audit findings for both the internal and supplier audit programs during Quality Management Meetings.
- Supports Quality management contact with the FDA, EMA and other regulatory authorities worldwide as well as partners regarding quality issues including field alerts, recalls or regulatory actions.
- Supports GMP inspections and audits from both regulatory authorities and partners and supports drafting of follow-up responses for all aspects of the business.
- Supports other GXP functions, as required.
- Supports and participates in the supplier change notification and supplier complaints.
- Performs other duties, as assigned
- Travel up to 50%, domestic and international
Qualifications
• Bachelor’s Degree in Life Sciences or Engineering with 9+ years of applicable cGMP experience OR
• Masters in Life Sciences or Engineering and 7+ years of applicable cGMP experience OR
• PhD in Life Sciences or Engineering and 5+ years of applicable cGMP experience
•5+ years’ experience of auditing experience
• Prior Experience and Knowledge of pharmaceutical industry and regulations
Preferred Skills
- Previous experience of Smartsheet, Track wise, Master Control, Veeva and/or Kneat validation software
- Occasional opportunity for International and/or Domestic travel may be available
- Experience conducting internal audits
- Certified ISO 9001 Auditor Training
- ASQ - Certified Quality Auditor
