Director QA Operations
Build our future together:At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Director, Quality Assurance to provide the quality support and oversight for drug substance manufacturing operations at the Regeneron Drug Substance (DS) facility. The position is responsible for the QA DS team overseeing any or all of the following production processes: cell culture, centrifugation, chromatography, ultrafiltration/diafiltration (UFDF), and aseptic dispensing of bulk drug substance. The director will provide the leadership, direction, and the overall Quality oversight of the manufacturing area ensuring they meet current FDA and International Regulatory Body requirements.When & where:Location: Rensselaer, NYWork model: Monday-Friday, 8am-4:30pmDiscover your role:Build and execute a business strategy that translates vision and corporate goals into departmental objectivesBuilds and maintains a high performing team of managers, providing effective alignment and communication with functional groups at the site and at other manufacturing sites, to successfully deliver on all commitments. Sets the course for the future- defines priorities, goals and objectives for quality teamProvide direction, set performance standards, evaluate, develop performance and inspire direct reportsEnsure quality floor staff are appropriately trained to support plant operations, ensuring risks are identified and resolved. Responsibilities include in-process testing oversight, line clearance checks (as necessary), batch record review, return to service requirements have been met and quality-on-the-shop-floor responsibilities of first response to product quality issues in productionProvide career development and training advice. Provide regular feedback to direct reports on company and departmental operationsDirects the activities of resources, both internal and outside contractors/vendors, with similar technical or functional responsibilitiesLead cross functional teams and manages the deliverables for the assigned projects. Drives projects through completion within timeline, quality and budgetary constraints. Interfaces with senior management to report on project and program milestones and to present project needsProvides escalated response for Quality and Compliance issues on the manufacturing floor and assures that decisions are made at the proper level and with the appropriate insights.May provide review and final QA approval of deviations, and other quality events; protocols/reports; change documentation, SOPs; master batch record approvalEnsures product, facility, and equipment holds are placed when batch, equipment or system integrity is questionedResponsible for representing the Company and directly interfacing with auditors during regulatory body inspectionsEnsures periodic informal audits are completed in productionLeads teams for tracking of quality activities,...