Department: Azzur Austin, LLC
Job Title: Quality Assurance Senior Manager
Department: Consulting Services
Division: Azzur Consulting
Location: Nationwide/Remote, preference for the East Coast
Working Hours: Core Hours
Summary Objective of position:
The Quality Assurance Senior Manager for Consulting Services is responsible for managing personnel and work for the master Quality Management System (QMS) documents delivered to clients, Client supplier audits (GLP, GCP, GMP), and high-level Quality Assurance Strategy and Task consulting. Core responsibilities include service execution, client interactions and maintaining relationships, attracting and retaining personnel and project management. This position requires knowledge of pharmaceuticals, biopharmaceuticals, and medical devices as well as front-room experience with FDA EU/EMA inspections.
Client-related Responsibilities include:
• Authoring and reviewing master and client Quality Management System procedures, forms and templates
Some travel is required (approximately 20%)
- Support the internal Quality Management System used for consulting
- Internal Azzur Group Clean Rooms on Demand Manufacturing auditing
- Internal Azzur Group Laboratory auditing
- Internal training
- Assisting with client complaints
- Financial reports support
The Quality Assurance Senior Manager is also a partially Billable Resource, as needed, in support of the Office’s financial goals and objectives, and a client’s Quality Assurance or project management work.
Execute the tactical activities required to maintain revenue and profitability, manage business risks and implement the strategic direction such as assist and review financial report and client complaints
Client Supplier Audits Management and conducting audits
Oversee the master Quality Management System and Quality Assurance aspects of documents delivered to clients
Quality Assurance Consulting (Pre-Approval Inspection Readiness and Regulatory Agency response client support, Risk Analysis, CAPA and Deviation writing, Root Cause Investigations, and mentoring other consultants.
Internal Quality Management System and Training support
Promoting teamwork by:
- Meets leadership goals by:
Maintains technical knowledge by attending educational workshops and/or reviewing publications.
Other duties as assigned by Sr. Management
Adhere to all Standard Operating Procedures (SOPs) and Industry Regulations/Standards
Training & Development:
Ensure training has been received before undertaking specific duties and that all training is documented in training records.
Health & Safety:
Understand the company’s Health & Safety Policy and follow all associated procedures. Report all accidents or awareness of any unsafe conditions in the workplace to management.
Human Resource Management:
Conform to the company’s policies contained in the Employee Handbook
Basic Qualifications & Position Requirements:
• Knowledge of Quality Assurance tools and regulatory/standards documentation requirements
Skills (Inc. Typical Mental Demands):
Reasoning Ability/Mathematical Skills/Computer Skills/Language Skills:
• Flexible and able to work on several projects/clients
• Customer service/client relations
• Communication proficiency
• Attention to detail
• Can work productively independently with minor supervision
• Self-motivated, flexible, dependable and available
• Excellent organizational and time management skills
Work Environment & Dress attire:
Business casual in the office, business professional on client sites/during client visits and presentations and trade shows.