Director QA Operations

About the role

Provide quality support and oversight for drug substance manufacturing operations at the Regeneron Drug Substance (DS) facility. Responsible for the QA DS team overseeing production processes including cell culture, centrifugation, chromatography, ultrafiltration/diafiltration (UFDF), and aseptic dispensing of bulk drug substance. Provide leadership, direction, and overall Quality oversight of the manufacturing area ensuring compliance with current FDA and International Regulatory Body requirements.

Responsibilities

• Build and execute a business strategy that translates vision and corporate goals into departmental objectives
• Build and maintain a high performing team of managers, providing effective alignment and communication with functional groups at the site and at other manufacturing sites
• Set the course for the future—define priorities, goals and objectives for quality team
• Provide direction, set performance standards, evaluate, develop performance and inspire direct reports
• Ensure quality floor staff are appropriately trained to support plant operations, ensuring risks are identified and resolved
• Oversee in-process testing, line clearance checks (as necessary), batch record review, return to service requirements, and quality-on-the-shop-floor responsibilities of first response to product quality issues in production
• Provide career development and training advice; provide regular feedback to direct reports on company and departmental operations
• Direct activities of resources, both internal and outside contractors/vendors, with similar technical or functional responsibilities
• Lead cross functional teams and manage deliverables for assigned projects; drive projects through completion within timeline, quality and budgetary constraints
• Interface with senior management to report on project and program milestones and to present project needs
• Provide escalated response for Quality and Compliance issues on the manufacturing floor and assure decisions are made at the proper level and with the appropriate insights
• Provide review and final QA approval of deviations, quality events, protocols/reports, change documentation, SOPs, and master batch record approval
• Ensure product, facility, and equipment holds are placed when batch, equipment or system integrity is questioned
• Represent the Company and directly interface with auditors during regulatory body inspections
• Ensure periodic informal audits are completed in production
• Lead teams for tracking of quality activities, metrics, CAPA tracking, etc.; report metrics and assess data trends to work with operating departments to facilitate process improvements
• Develop or support procedure and process development for continual improvement of cell culture operations, centrifugation/harvest, chromatography, UFDF, viral clearance, aseptic dispensing, filling batch records, and segregation/hold process
• Provide leadership and direction to the manufacturing and support area departments to ensure a constant state of inspection readiness
• Influence others to achieve results and challenge the status quo

Qualifications

• Bachelor's degree in Life Sciences or related field, or equivalent combination of education and experience
• Minimum of 12 years experience in a Quality Operations, Quality Management or manufacturing role, in a late stage or early stage start-up Drug Substance/biologics company

Schedule & Location

Rensselaer, NY. Monday-Friday, 8am-4:30pm.