Director/Senior Director, Quality Assurance (San Diego)
About the Company Protego discovers and develops first-in-class small molecule therapeutics that reprogram protein folding to treat monogenic protein misfolding diseases, including myopathy, cardiomyopathy, stroke, renal, retinal, and other degenerative diseases and channelopathies. Our approach builds on the pharmacological chaperone strategy pioneered by our cofounders, Dr. Jeffery W. Kelly and Dr. Richard Labaudinière, in tafamidis for transthyretin amyloidosis. About the job Protego Biopharma is seeking a Director / Senior Director, Quality Assurance — the company's first dedicated QA hire. Reporting to the SVP of Regulatory Affairs, this person will build and evolve a risk-based, phase-appropriate QMS and oversee all GxP activities as Protego advances its lead AL amyloidosis program from proof-of-concept into a global, registrational Phase III trial. The role is weighted toward GCP and GVP to support start-up and conduct of the global pivotal trial and its PV system, plus fit-for-phase oversight of outsourced GMP (CDMO/CMC) and remaining GLP activities. This is a hands-on, build-stage role: QMS documentation is initially authored by a contracted QA vendor under the incumbent's oversight, directing fractional external resources rather than a standing internal team, scaling as the portfolio grows toward NDA/MAA. Posted at two levels: Director for a strong player-coach with phase-appropriate QMS build experience; Senior Director for a candidate who also brings first-QA-hire leadership, sponsor-side inspection management, and experience standing up GCP/GVP oversight for a registrational program. Scope is identical; title reflects experience depth. Primary Responsibilities Quality Management System (QMS) Establish and evolve a right-sized, risk-based, phase-appropriate QMS spanning GCP, GVP, GLP, and outsourced GMP, avoiding over-engineering while ensuring inspection readiness and room to scale. Direct the QA vendor engaged to author the QMS suite (Quality Manual, policy, SOPs, work instructions, templates); review deliverables for fit-for-phase content, and progressively bring authoring in-house as the function matures. Stand up and administer core quality processes: document control, controlled training (LMS), deviation/nonconformance management, CAPA, change control, quality risk management, and the audit program. Implement and validate fit-for-purpose eQMS / DMS / LMS systems, ensuring 21 CFR Part 11 / EU Annex 11 compliance and data integrity (ALCOA) across the records lifecycle. Define and maintain GxP training on fundamentals and role-based curricula; ensure staff and contractors have SOP awareness before performing regulated activities. GCP Quality Oversight (primary focus) Lead GCP quality strategy for the proof-of-concept study and global pivotal Phase III trial across the US, EU, UK, APAC, and LATAM, ensuring compliance with FDA, EMA, MHRA, ICH E6(R3), and regional requirements. Serve as primary QA interface to Clinical Development and Operations; embed quality-by-design and risk-based thinking into protocol, vendor, and study-conduct decisions. Develop and execute a risk-based clinical audit strategy covering CROs, central labs, specialty vendors, sites, and the TMF; conduct/oversee audits and drive timely CAPA closure. Provide quality oversight of the proof-of-concept-to-pivotal transition, ensuring data integrity and continuity of systems, vendors, and documentation across phases. Oversee GCP deviations, serious breaches, and quality issues through investigation, root-cause analysis, and CAPA. GVP / Pharmacovigilance Quality Oversight (primary focus) Establish and oversee a phase-appropriate pharmacovigilance system aligned with GVP modules and FDA, EMA, and other regional expectations. Oversee PV vendor performance and audit the PV system, including safety data management, expedited/aggregate reporting, signal management, and the PSMF. Partner with the CMO on PV system compliance, audits, and inspection readiness. Outsourced GMP & GLP Oversight Provide QA oversight of CDMO/CMO and external QC lab activities supporting IMP manufacture, testing, and clinical supply. Review and approve CMC quality records (deviations, OOS, change controls, specifications, IMP release) and coordinate with the QP for EU IMP certification as required. Provide QA oversight of remaining nonclinical (GLP) activities and vendors as applicable. Supplier / Vendor Quality Management Build and run supplier qualification, requalification, and performance-monitoring across CROs, CDMOs, labs, and specialty vendors. Negotiate and maintain Quality Agreements; define oversight expectations and escalation paths for each critical vendor, including QA and QMS-authoring vendors. Inspection Readiness & Regulatory Interface Maintain continuous inspection readiness across all GxP areas. Serve as quality lead for health authority inspections (FDA, EMA, MHRA, others); prepare the organization, host inspections, and lead responses to findings. Liaise with internal and external stakeholders on quality matters and represent QA in cross-functional and governance forums. Quality Leadership & Continuous Improvement Direct fractional and contract QA resources; ensure quality and timeliness of outsourced deliverables, and define when to convert capacity to FTEs as programs scale. Establish, track, and report quality metrics and trends; lead periodic Quality Management Review with leadership. Track the evolving global GxP landscape, including rare-disease and accelerated-development considerations, and update the quality program accordingly. Propose pragmatic solutions to difficult situations and champion a proportionate, risk-based quality culture suited to a small organization. Required Qualifications Bachelor's degree or higher in a scientific/life sciences discipline; advanced degree preferred. Director: 10 years of progressive pharma/biotech QA experience with depth in GCP and GVP. Senior Director: 12–15 years, including prior first-QA-hire or function-building accountability. Experience building and maintaining a phase-appropriate QMS from limited or early-stage infrastructure at a small or emerging company. Hands-on sponsor-side QA oversight of CROs, vendors, and CDMOs/external labs, including quality agreements, audits, deviations/CAPA, and issue resolution. Experience supporting start-up and conduct of global, multi-region trials (US, EU, UK, APAC, LATAM); pivotal/registrational experience preferred. Experience establishing or overseeing a pharmacovigilance (GVP) quality system. Direct experience hosting/managing health authority inspections (FDA and/or EMA/MHRA) and responses to observations. Working knowledge of outsourced GMP/CMC quality oversight for clinical supply; GLP/nonclinical experience a plus. Comfortable in a lean start-up environment; able to manage multiple priorities with limited infrastructure. Preferred Qualifications Familiarity with region-specific GCP/quality requirements and inspectorates across APAC and LATAM. Experience with seamless / adaptive trial designs and related data-integrity considerations. Experience implementing and validating eQMS / DMS / LMS platforms. Familiarity with FDA & EMA expedited approval frameworks and rare-disease pathways from a quality-oversight perspective. Quality or auditing certification (e.g., ASQ CQA, RAC, or equivalent). Core Competencies Quality Leadership: Sets and owns quality strategy and standards; builds a function and influences decisions across a lean organization. Phase-Appropriate Judgment: Right-sizes controls to stage and risk; applies global GxP requirements pragmatically, not maximally. Vendor & Stakeholder Management: Directs fractional/contract resources and holds external partners, including the QMS-authoring vendor, to clear expectations. Inspection Command: Maintains audit/inspection readiness and represents the company credibly before health authorities. Hands-On Builder: Operates as a player-coach in a fast-moving environment with limited support infrastructure. Patient Focus: Motivated to advance therapies for patients with serious, underserved rare diseases. Compensation $215,000 - $260,000 a year In addition to a competitive base salary of $215,000–$260,000, we offer stock options and a target bonus, plus a comprehensive benefits package for employees and their families, including medical, dental, vision, and supplemental disability insurance. Relocation assistance may be available. The salary range is a guideline; total compensation will vary based on qualifications, skill level, competencies, and internal equity. Job Type: Full-time Benefits Annual bonus program Incentive stock option plan 401k plan with employer cont
