СШАSupply Chain Quality Manager
1 нед. назад
СШАSeniorHybrid
auditquality management systemcapasupplier qualificationsupplier performance evaluation
Lead and build supply chain quality management processes, including supplier qualification, audits, and compliance management in telehealth supply chain.
О компании
- OpenLoop was co-founded by CEO, Dr. Jon Lensing, and COO, Christian Williams, with the vision to bring care anywhere. Our telehealth support solutions are thoughtfully designed to streamline and simplify go-to-market care delivery for companies offering meaningful virtual support to patients across an expansive array of specialties, in all 50 states.
- We have a relatively flat organizational structure here at OpenLoop. Everyone is encouraged to bring ideas to the table and make things happen. This fits in well with our core values of Autonomy, Competence and Belonging, as we want everyone to feel empowered and supported to do their best work.
- Sound like a good fit? We’d love to meet you.
Обязанности
- OpenLoop’s mission is to bring care anywhere by powering telehealth solutions at scale. The goal of this team is to build the supply chain quality process from the ground up and centralize all quality supply chain functions to one team. The goal of this role is to build a best in class quality management system.
- Lead supplier qualification and ongoing audit programs across API, excipient, and packaging vendors, including on-site and remote audits, documentation review, and risk-tiered qualification criteria
- Own the Approved Vendor List (AVL) process, managing hard-gate compliance checks (FDA facility registration, CoA traceability, USP monograph compliance) and periodic requalification cycles
- Conduct supplier scorecards and performance evaluations covering quality metrics, delivery reliability, non-conformance rates, and corrective action responsiveness
- Manage CAPA (Corrective and Preventive Action) processes for supplier-related quality deviations, tracking root cause analysis and verification of effectiveness
- Ensure supplier and incoming material compliance with applicable state board and USP standards (e.g., USP <795>, <797>, <800>, <1079>) across multi-state pharmacy operations
- Partner with procurement and compliance teams to maintain audit-ready documentation, support regulatory inspections, and drive continuous improvement in vendor quality standards
- Other duties as assigned.
Требования
- Bachelor's degree in supply chain management, quality assurance, pharmaceutical sciences, or a related field (or equivalent practical experience)
- 4+ years of experience in supply chain quality, vendor quality assurance, or supplier auditing, ideally within pharmaceutical, compounding, or regulated manufacturing environments
- Deep familiarity and working knowledge of FDA 503A/503B regulations, USP compounding standards, and cGMP principles as they apply to suppliers and incoming materials
- Skilled at running structured audits and translating findings into clear, actionable corrective action plans
- Detail-oriented and comfortable owning documentation-heavy processes (CoAs, qualification files, audit reports) that need to hold up under regulatory scrutiny
- A collaborative operator who can work cross-functionally with procurement, compliance, and operations without slowing down the business
- Certified or working toward certification (ASQ CQA, CSQP, or equivalent) is a plus, but hands-on audit experience matters more than the credential
- Proven track record managing CAPA processes, including root cause analysis and effectiveness verification
- Demonstrated experience conducting supplier audits (on-site or remote) and managing vendor qualification/re-qualification processes
Будет плюсом
- Experience working with 503A or 503B compounding pharmacies, across multi-state/multi-site pharmacy networks (Texas, Alabama, California a plus), and/or FDA-regulated manufacturing
- ASQ Certified Quality Auditor (CQA), Certified Supplier Quality Professional (CSQP), or equivalent certification
- Familiarity with API and packaging component sourcing, including CoA review, FEI/facility registration verification, and distributor vs. manufacturer qualification
- Hands-on experience with NetSuite, Ramp, or ComplianceQuest (or similar ERP/spend management/QMS platforms) for supplier and quality data tracking
- Experience navigating state board of pharmacy requirements as they relate to supplier compliance
- Background in building or scaling a supplier quality function from the ground up, rather than just operating within an established one
Условия
- In addition, for salaried positions you would also be eligible for:
- Medical, Dental, and Vision plans
- Flexible Spending/Health Savings Accounts
- Flexible PTO
- 401(k) + Company Match
- Life Insurance, Pet insurance, and more