Manager QA Quality Management System (QMS)

At Bend Bioscience, our core values shape how we work, lead, and grow—together. We’re a High Science, High Service, people‑centered company, committed to amplifying the potential of medicines. Our team thrives on being authentic, curious, and accountable, while staying flexible, collaborative, and driven by care. We blaze trails by challenging the status quo, pursuing excellence in everything we do, and maintaining relentless focus on delivering real impact. Whether you're in the lab, on the floor, or supporting our clients, your work at Bend Bioscience will matter. You’ll join a team that values continuous learning, bold thinking, and doing the right thing—even when it's hard. How You Will Make An Impact Build and develop a high-performing QA team responsible for audits, quality metrics, training oversight, APRs/PQRs, change control governance, and QMS documentation by establishing clear development pathways, coaching staff to grow beyond their current roles, and ensuring team capability is aligned with organizational and regulatory requirements. Establish and maintain a performance management framework that sets clear expectations, drives accountability, and differentiates performance; partner with HR to address performance gaps and recognize high contributors. Lead recruitment, selection, and onboarding of qualified QA personnel; develop retention strategies and succession plans to sustain team capability, continuity, and organizational bench strength. Function as the decision‑making authority for quality issues within the team's scope; apply risk‑based judgment to resolve complex issues independently and determine when escalation to senior quality leadership is warranted; identify and address root causes of recurring escalations. Own and maintain the Quality Management System (QMS), ensuring all elements — SOPs, records, and governance processes — remain compliant with FDA, ICH, and applicable global regulatory standards and are aligned with current business and regulatory requirements. Lead the internal audit program and oversee all regulatory inspections and customer audits across applicable sites, including inspection readiness, scheduling, execution, response development, and timely closure of all commitments. Oversee the CAPA system to ensure timely initiation, risk‑based root cause analysis, effective remediation, and verification of effectiveness; monitor CAPA trends to identify systemic quality risks and drive sustainable QMS improvements. Establish, monitor, and trend key quality performance indicators (KPIs) and metrics to assess QMS effectiveness; prepare performance summaries, dashboards, and risk assessments to support Management Review and inform senior leadership decisions. Govern the change control process to ensure all changes are assessed for quality, validation, regulatory, and business impact; verify that changes resulting from audits, investigations, APRs/PQRs, or continuous improvement initiatives are effectively implemented and documented. Oversee the planning, execution, review, and approval of Annual Product Reviews (APRs) and Product Quality Reviews (PQRs), ensuring evaluation of trends across deviations, complaints, CAPAs, changes, and process performance, and that outcomes are translated into actionable improvements. Oversee GMP and role‑based training compliance across all personnel; monitor training metrics and effectiveness to ensure sustained compliance and ensure training content remains aligned with current SOPs and regulatory expectations. Manage supplier qualification and oversight for applicable sites, including external audits, risk assessments, quality agreements, and approval of suppliers across laboratories, manufacturers, packagers, and component manufacturers; participate in Material Review Board activities to support quality governance. Ensure QMS documentation — including SOPs and quality records — is maintained, periodically reviewed, and updated to reflect current regulatory expectations, operational practices, and business needs. Partner with Manufacturing, Technical Operations, Regulatory Affairs, Supply Chain, and Engineering to ensure alignment between day‑to‑day operations and QMS requirements, and to maintain a validated and compliant state across all functions. Communicate quality trends, audit outcomes, inspection results, and system performance to senior leadership through regular reporting, management review meetings, and executive summaries to support informed, risk‑based decision‑making. What You Will Bring To The Role Education: Bachelor’s degree in Life Sciences, Chemistry, or a related scientific discipline (Master's preferred) Experience: 7+ years of Quality Assurance experience in an FDA‑regulated pharmaceutical environment, with 4+ years of people leadership experience and demonstrated experience supporting regulatory inspections and customer audits, including response development and commitment management. In addition: Comprehensive cGMP and global regulatory knowledge (FDA, ICH) applied to solid oral and liquid dosage manufacturing in a CDMO environment. Working command of QMS pillars — audits, CAPA, change control, training, metrics, APRs/PQRs, and validation — to sustain inspection readiness. Strong analytical and risk‑based decision‑making, interpreting quality trends, metrics, and technical data to resolve complex issues. Proven experience leading internal audits and supporting regulatory inspections, including response development and commitment tracking. Skilled at establishing KPIs and executive‑level reporting through dashboards and management review inputs. Effective communicator able to present complex quality and compliance information to senior leadership, regulators, and customers. Work Environment: Onsite - Clearwater, Florida #J-18808-Ljbffr