Position: Senior QA Manager

Description: The Senior QA Manager reports to the Senior Director of Quality Assurance and is primarily responsible to oversee the development, optimization and management of Inspiration Biopharmaceutical’s Quality Systems.

Job Responsibilities

• Works with Senior Management and other Quality staff to oversee the development and implementation of an FDA/ EMEA compliant Quality Systems for GCP/GMP/GLP activities.
• Provides expert GCP/GMP/GLP compliance and general QA support; acts as liaison between product manufacturing/development teams and QA.
• Support internal and external (domestic and international) GXP-related audits, including System/Process Audits, Vendor Audits (CROs, Labs, CMOs). Supports 'for cause' audits, as necessary.
• Revise and maintain comprehensive document control system:
• Revise and relaunch current internal controlled document system
• Creates, revises, reviews, and approves quality-related documents, including batch production records, stability testing protocols, procedures, validation protocols, and reports.
• Reviews SOPs to ensure compliance with applicable regulatory and corporate standards.
• Interface with regulatory operations for eCTD submission preparation
• Establish and manage company change control system for internal and partner-related change management.
• Establish and maintain a hard copy filing system for QA and QC hard copy records and packages. Set up and maintain controlled electronic QA Quality systems on company’s Nuxeo Document Management System.
• Establish and maintain company CAPA system
• Participates in the development and delivery of internal training programs.
• Supports the preparation, coordination, and management of regulatory agency Preapproval inspections. During inspection, plays support role as facilitator and communicator.
• Keeps up to date with current regulatory guidelines and regulations.

Experience and Background

• Requires a Bachelors Degree in a scientific discipline
• Minimum of 8 years’ previous experience in a pharmaceutical quality assurance/compliance/GXP auditing role or equivalent amount of work experience.
• At least 3 of these years must have been in a QA Manager role.
• Must understand business processes/project management and have previous knowledge of regulatory environment impact and pharmaceutical development programs (GMP’s, GCP’s, NDA submission, ICH, etc.).
• A previous background in project planning, budget planning, project control, and quality assurance management, etc.
•  Must maintain comprehensive proficiencies with Microsoft Office and associated applications.

Compensation and Benefits

Inspiration Biopharmaceuticals offers an excellent total compensation package which includes competitive base pay, bonus, stock options, and excellent benefits along with a flexible work environment. 

Please submit your resume and inquiries to Human Resources at careers@inspirationbio.com.