Supplier Quality Manager

VERO BIOTECH INC•Atlanta, GA

1d•Onsite

About The Position

Responsible for ensuring that the quality of products being supplied to the organization meet the prescribed quality levels. Responsible for managing the day-to-day activities and operations of the Supplier Quality department. Monitors the performance of suppliers while identifying potential issues to improve quality and efficiency, implementing process improvement strategies. Provides support to direct reports.

Requirements

College degree required, preferably in a scientific discipline.
5+ years experience in FDA/cGMP regulated environment.
FDA 21CFR210/211/820 and ISO13845.
Strong analytical and communication skills with keen attention to detail.
Must have strong organization skills with attention to detail and accuracy.
Proficiency in the use of MS Word, Excel and Outlook.
Must have good basic mathematical skills
Fluent in English (verbal and written)
Ability to read and understand technical drawings and schematics.
Ability to respond to and answer/solve technical questions and problems.

Nice To Haves

MS Access and other software tools, a plus.
fluency in other languages is a plus
Auditing experience or certification preferred

Responsibilities

Support the strategic Supplier Management process to meet quality, delivery, cost objectives and ensure compliance.
Monitors the Supplier quality system, including records and results from processes and procedures to ensure product Quality and compliance
Schedules and manages supplier audit schedules and metrics to maintain the approved supplier list and ensure quality of suppliers approved/use
Ensures supplier quality documentation is accurate, maintained, and reflects GMP, procedural and regulatory requirements.
Monitors KPIs and performs data trending for supplier quality metrics
Arranges routine (weekly/monthly) meetings with key suppliers and contract manufacturers (CMOs)
Maintains knowledge of current regulatory requirements pertaining to drug/device manufacturing and communicates requirements to other associate staff.
Initiates and maintains supplier corrective actions (SCAR) responses to ensure on-time closure
Assists other departments by providing supplier contacts for change notification actions
Evaluates acceptability and compliance of suppliers on the approved supplier list (ASL); including new supplier approvals and ongoing supplier file maintenance in accordance with procedures and regulations
Participates in investigations of quality issues, as required. Provides analysis and trend information to support these activities.
Performs supplier audits for new suppliers, ongoing requalification and for-cause audits
Updates Standard Operating Procedures (SOPs) for supplier quality processes.
Participates in continuous improvement objectives to assure compliance with regulations.
Supports internal audits and regulatory inspections.
Lead and mentors Quality personnel, including promoting quality culture and supporting quality objectives.
Other related duties as assigned.