Director, Quality Operations and Quality Control
$190,000–$210,000 year
On-site · Devens, Massachusetts, United States or North Andover, Massachusetts, United States
Job Summary
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. The role ensures day-to-day Quality Assurance aspects of manufacturing, testing, reporting, issue resolution and batch disposition of active pharmaceutical ingredients and intermediates meet GMP/regulatory requirements. Fully onsite first shift at the Devens, MA facility. Responsibilities include strategy creation and implementation for QO/QC, workload planning and budgeting, ensuring batch compliance, leading investigations and CAPA, QMS governance, LIMS/TrackWise improvements, stability program management, SOP and method development, data integrity review, cross-site technology transfers, leadership engagement, regulatory inspections support, and occasional travel within the region. The role emphasizes collaboration with Regulatory Affairs, QC, site leadership, and customers, and requires oversight of QC laboratory operations, training and coaching of staff, and a strong emphasis on quality metrics and continuous improvement. Competitive base salary range with annual bonus eligibility, comprehensive benefits, tuition assistance, and a commitment to equal employment opportunity. Applicants must be authorized to work in the United States without sponsorship.
Required Qualifications
- BS or equivalent in Chemistry 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
- Expert knowledge in process validation, production equipment qualification, environmental controls, and change management
- Experience with customer complaint investigations
- Knowledge of basic microbiology and contamination control as they apply to drug substance manufacturing
- Familiarity with risk management principles and decision making based on risk management
- Familiarity with project management and ability to lead improvement projects across multiple sites
- Strong experience with Microsoft Office applications
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