0d59d750-7861-4c2e-92f4-c7da49dd100a Verified 32h ago
Director, Quality Operations and Quality Control
Devens, MA, 01434 On-site
$190,000–$210,000 a yearPay$190,000–$210,000
TypeFull-time
Work settingOn-site
Verified listing
JobFig found this opening at its original source and checks that it remains available.
About the role
The Director, Quality Operations and Quality Control leads the Quality Operations function and Quality Control test labs for the Veranova sites located in Devens, MA and North Andover, MA. In collaboration with site Leadership, it is the responsibility of this role to ensure the day to day Quality Assurance aspects of manufacturing, testing, reporting, issue resolution and batch disposition of active pharmaceutical ingredients, intermediates meet the compliance requirements applicable to drug substance manufacturing of pharmaceutical products.
What you'll bring
- BS or equivalent in Chemistry, Engineering or related Science
- 15+ years experience within GMP Quality Assurance and Quality Control in an FDA/EMA regulated industry
- 10+ years directly managing performance and development of staff members
- 7+ years experience with batch production, control and disposition processes and QC Laboratory testing
- Expert knowledge in Root Cause Analysis, Investigations, CAPA and CAPA Effectiveness
- Familiarity with Veeva, Master Control, LIMS and ERP systems
- Experience within Drug substance manufacturing
- Working knowledge of US & EU GMP, ICH Q7 and Part 11 compliance
- Experience with customer complaint investigations
- Knowledge of basic microbiology and contamination control as they apply to drug substance manufacturing, specifically bioconjugation operations
- Ability to Plan, Organize, Prioritize and Monitor workload across multiple sites and customer projects
- Familiarity with risk management principles and capable of decision making based on risk management
Benefits
Paid Time OffTuition Assistance