QA Director

SparX Biopharmaceutical·
Mount Prospect, IL, USA
2w ago
Full-timeSeniorQuality AssuranceBiologicsAntibody Drug Conjugate (ADC)Bachelors
Market Rate — Compliance Officers
25th
$59K
Median
$76K
75th
$101K

BLS 2024 data (national)

Description

Sparx Group is seeking a QA Director to oversee Quality Assurance activities at the Mount Prospect biologics manufacturing facility. Responsibilities include developing quality assurance goals, implementing and improving the quality management system (QMS), creating and implementing product quality documentation, maintaining product quality, reviewing and approving quality documents, leading investigations and CAPA, establishing audits and qualification programs, conducting regular GMP audits, and providing employee training. The role requires the candidate to guide 'on the floor' and ensure compliance with regulatory guidelines.

Requirements

Bachelor's degree in a relevant scientific discipline (biology, biotech, pharmaceutical, or biochemistry) with at least 10 years of quality management experience in a regulated Biologics pharmaceutical manufacturing environment or a Master's degree with at least 7 years of relevant experience. Must have a minimum of 5 years in QMS at a managerial level. Knowledge of GMP, FDA, and ICH/VICH regulations is required. Must possess skills in MS Word, Excel, Project Management, communication, collaboration, and leadership.
SB

SparX Biopharmaceutical

PHARMACEUTICAL

Antibody Therapies

LocationIL - Mount Prospect
Open Jobs11
Biologics
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