503B Director of Quality Assurance/Quality Control at DeliverIt Pharmacy Bedford Inc

Sugar Land, Texas, United States -

Full Time

Start Date

Immediate

Expiry Date

12 Jun, 26

Salary

165000.0

Posted On

14 Mar, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

QMS Design, SOP Authoring, Batch Record Management, Deviation Management, CAPA, Change Control, OOS Management, Sterility Assurance, Environmental Monitoring, Aseptic Processing, Regulatory Readiness, FDA Inspection Management, Supplier Qualification, Cleanroom Validation, CSV, Team Leadership

Industry

Hospitals and Health Care

Description

Description ABOUT DELIVERIT OUTSOURCING & SOLUTIONS DeliverIt Outsourcing & Solutions LLC is a new-build FDA 503B outsourcing facility focused on sterile injectable compounding, located in Sugar Land, Texas — part of the greater Houston metro area. We are a subsidiary of DeliverIt Group, an established healthcare management and pharmacy services company with retail and specialty pharmacy operations across Texas. We are building a state-of-the-art ISO-classified cleanroom facility designed to supply hospitals, health systems, and ambulatory care clinics across the United States with high-quality, cGMP-compliant sterile preparations. Anchor clients include major Houston-area health systems, and we have established pharmaceutical distribution and supply agreements with leading national partners including McKesson and Pfizer. This is a rare ground-floor opportunity to join a well-capitalized startup with an experienced leadership team — and to own quality from day one. THE OPPORTUNITY We are seeking a Director of Quality Assurance / Quality Control to join our founding leadership team as we prepare for FDA facility registration and commercial launch. This is a builder's role — not a maintenance role. You will establish our Quality Management System, author our SOPs and batch records, oversee cleanroom qualification and validation, build our QC laboratory, and lead our regulatory readiness program. If you have the expertise to architect a 503B quality program from scratch and the drive to do it, this role is for you. Why this role stands out: • Own the quality architecture of a new facility — from SOP #1 through first FDA inspection. • Report directly to the President & CEO with full executive support and resource backing. • Competitive compensation with bonus eligibility and potential equity for the right candidate. • Located in Sugar Land — one of the most livable and affordable cities in the Houston metro, with no Texas state income tax. Relocation assistance available Medical, Dental, and Vision insurance sponsored by DeliverIt 401(k) Performance-based bonus program General PTO & paid federal holidays • Join a leadership team with deep pharmacy, healthcare, and regulatory experience. KEY RESPONSIBILITIES Quality Management System • Design and implement the full QMS from the ground up: SOPs, batch records, deviation management, CAPA, change control, OOS, and complaint handling. • Ensure compliance with 21 CFR Parts 210/211, USP 797, 71, 85, 1, and FDA 503B outsourcing facility guidance. • Lead IQ/OQ/PQ validation of all equipment, utilities, and cleanroom systems; establish computerized system validation (CSV) program. • Maintain annual product review (APR), site master file, and quality metrics reporting. Sterility Assurance & Environmental Monitoring • Direct all sterility assurance programs: environmental monitoring (EM), media fill qualifications, aseptic technique oversight, and gowning program. • Manage sterility testing, LAL/endotoxin testing, container closure integrity, and particulate monitoring programs. • Maintain ISO 5/7/8 cleanroom classification and ensure ongoing compliance through trending and corrective action. Quality Control Laboratory • Oversee raw material, in-process, and finished product testing; manage release and rejection decisions. • Ensure instrument qualification, method validation, analyst training documentation, and reagent management. • Manage contract laboratory relationships; review and approve CoAs and external test results. • Establish reference standards, stability programs, and retain sample management. Regulatory Affairs & Inspection Readiness • Serve as primary FDA contact; lead facility through registration, pre-approval, and routine inspections. • Prepare and manage responses to FDA 483 observations and warning letters. • Monitor FDA guidance updates, USP chapter revisions, and federal/state regulatory changes. • Coordinate with DEA for Schedule II–V compliance, ARCOS/CSOS reporting, and controlled substance quality requirements. Supplier & Vendor Quality • Qualify and audit API suppliers, excipient vendors, contract manufacturers, and testing laboratories. • Maintain approved vendor list (AVL); review and execute vendor quality agreements. • Interface with McKesson, Pfizer, and other supply partners on quality and compliance matters. Leadership & Team Development • Recruit, hire, and build the QA/QC team as the facility scales; define roles, responsibilities, and competency frameworks. • Lead GMP training programs; ensure training documentation is current and audit-ready at all times. • Collaborate cross-functionally with pharmacy, operations, and executive leadership on quality strategy. • Foster a quality-first culture from the earliest days of facility operation. Requirements QUALIFICATIONS Required • 7–10+ years of pharmaceutical quality experience, with at least 3–5 years in a director or senior manager role. • Hands-on experience in sterile pharmaceutical manufacturing — injectables, aseptic processing, or cleanroom operations required. • Deep knowledge of 21 CFR Parts 210/211, USP 797, 71, 85, and FDA 503B outsourcing facility regulatory framework. • Experience managing FDA inspections, preparing 483 responses, and leading regulatory readiness programs. • Experience with QMS/eDMS platforms, LIMS, and CSV in a regulated pharmaceutical environment. • Bachelor's degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biochemistry, or related scientific field. Strongly Preferred • Experience building a quality system in a greenfield, startup, or early-stage pharmaceutical facility. • PharmD, MS, or PhD preferred. • Active Texas Pharmacist license or eligibility to obtain; other state licenses considered. • Familiarity with DEA Schedule II–V compliance, ARCOS, and CSOS in a pharmacy or compounding setting. • Experience with URAC or ACHC accreditation in a compounding or specialty pharmacy environment. • ASQ Certified Quality Auditor (CQA) or equivalent quality certification. • Exposure to hospital and health system quality requirements — GPO contracting, formulary approval, and vendor credentialing processes. THE IDEAL CANDIDATE You are a seasoned pharmaceutical quality professional who has spent time in sterile manufacturing and knows what it takes to build — not just manage — a compliant facility. You are comfortable making independent quality decisions, including holds and rejections, and you stand behind them. You thrive in environments where the org chart is lean, the pace is fast, and your fingerprints will be on everything. You may be coming from a large pharma company, a contract manufacturing organization (CMO), a hospital pharmacy, or a 503A/503B compounding facility. What matters most is that you understand FDA's expectations for sterile manufacturing, you've faced an inspection, and you know how to build a team that's ready for the next one.

Responsibilities

This leadership role involves designing and implementing the entire Quality Management System (QMS) from scratch, including authoring SOPs, managing deviations, and overseeing all validation activities for equipment, utilities, and cleanroom systems. The Director will also direct sterility assurance programs, manage the QC laboratory testing, and serve as the primary contact for FDA interactions and inspection readiness.