Website Goodwin Biotechnology
Scope of Function:
Responsible for Supply Chain support for the biologics business to include, but not limited to, general oversight and management of internal qualified suppliers and material quality systems. Ensure resolution of supplier and material quality events and future action planning. Coordinate, schedule and administer supplier self-assessments, conduct supplier audits (paper, virtual, on-site, and as applicable) and provide guidance for incoming inspections (as needed). Responsible for the development and maintenance of raw material and component specifications in compliance with applicable regulations (i.e., FDA, USP, EP, JP, etc.).
Other primary attributes will include establishing and maintaining excellent communication links with suppliers, external customers, and internal stakeholders.
Reports to: Senior Manager/Director Quality Systems
- Manages the Supplier/Material qualification and change process. Schedules then executes supplier audits (paper, virtual, on-site). Maintains all supplier files, monitors adherence to Quality Agreements, ensures timely submission, auditee responses, and assessment of supplier corrective actions,
- Provides quality technical assessment on new product development teams originates new and/or revises existing raw material/component specifications to capture supplier changes and testing requirements.
- Monitors and provides guidance for supplier systems and materials inspections (as needed) throughout the product lifecycle.
- Manages the Internal audit program, which may include client-specific commitments.
- Uses knowledge of software packages for inputting and retrieving data (e.g. Excel, Word, Minitab).
- Conducts data collection and analysis to identify improvement opportunities / progress (metrics) within the Supplier/Material Qualification systems, and support execution of studies and investigations.
- Interfaces with stakeholders, customers, suppliers, partners and regulatory auditors (as needed) to identify, maintain, and monitor supplier requirements and compliance. This may include development of statistically significant sampling programs.
- Compiles, organizes and submits all customer requested raw material/component documentation for utilization in regulatory submittals.
BS in Science or related degree
- 3+ years of relevant work experience in a current FDA environment (preferably biologics or pharmaceuticals).
- Auditing experience in a pharmaceutical company strongly desired.
- Knowledge of cGMP, 21CFR, ISO, ICH, GLP, EP, PIC/S, and other applicable regulations, standards, directives and guidance.
- Certified auditor preferred
- Experience in developing, implementing and reporting quality system performance metrics.
- Ability to perform required duties with minimal supervision.
- Interacts with: all GBI employees, clients, consultants and global regulatory agencies (including the US and European)
- Flexible to travel domestically and internationally as required (up to 50% travel).
- Maintain confidentiality of company information.