About Next X Labs
Next X Labs LLC is seeking an experienced GMP Quality Systems Consultant to assist with the design, implementation, and continuous improvement of a scalable Quality Management System for regulated laboratory and pharmaceutical operations.
Position Summary:
The QA Manager / Quality Systems Manager will serve as the critical Quality leader responsible for designing the integrated Quality Management System (QMS) from the ground up and defining the quality culture for a growing company, Next X Labs. This role supports the GMP QC Chemistry and Microbiology Laboratories, peptide Active Pharmaceutical Ingredient (API) manufacturing operations, and the company's stability study programs for 503A compounding pharmacies.
Responsibilities include:
The QA Manager will establish and oversee company-wide quality processes including:
-Document Management, and Document Control, Change Control, and training records
-Deviations, Out-of-Specification (OOS) and Out-of-Trend (OOT) investigations
-Non-Conformance (CAPA) investigations and complaints
-Risk Management, Supplier Qualification, internal audit programs,
-Management review, Quality metrics, and continuous improvement initiatives
As operations mature, the role will transition from building the Quality Management System to leading its ongoing execution and continuous improvement. Responsibilities will expand to include oversight of Quality Assurance personnel, review and approval of controlled GMP documentation, management of quality investigations and CAPAs, coordination of validation and qualification documentation, oversight of training and competency programs, and leadership of internal audit and inspection readiness activities.
The QA Manager will ensure the organization maintains a continuous state of compliance and inspection readiness for FDA inspections, client audits, and ISO/IEC 17025 accreditation assessments. The QA Manager will work closely with Analytical Chemistry, Microbiology, Manufacturing, Facilities, Engineering, and executive leadership to foster a culture of quality throughout the organization. This individual will provide strategic guidance on regulatory compliance, quality risk management, and continuous improvement while ensuring that all laboratory and manufacturing activities are conducted in accordance with current Good Manufacturing Practices (cGMP), applicable FDA regulations, ICH guidance, USP standards, and ISO/IEC 17025 requirements. The successful candidate will be expected to build a scalable quality organization capable of supporting the company's growth into a leading pharmaceutical analytical testing laboratory and peptide API manufacturer.
Applicable Regulations and Guidance:
-21 CFR Part 210 – Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General
-21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
-21 CFR Part 11 – Electronic Records; Electronic Signatures
-FDA Guidance – Data Integrity and Compliance With Drug CGMP
-FDA Guidance – Quality Systems Approach to Pharmaceutical CGMP Regulations
-FDA Guidance – Process Validation: General Principles and Practices
-ICH Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
-ICH Q8(R2) – Pharmaceutical Development
-ICH Q9 – Quality Risk Management
-ICH Q10 – Pharmaceutical Quality System
-ICH Q12 – Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management
-ISO/IEC 17025 – General Requirements for the Competence of Testing and Calibration Laboratories
-USP <1220> – Analytical Procedure Lifecycle
-USP <1029> – Good Documentation Guidelines
Qualifications:
- Bachelor's degree (Master's preferred).
-10+ years of pharmaceutical QA or related experience.
-Experience building GMP Quality Management Systems.
-Experience with ISO/IEC 17025 implementation is a plus.
-Strong technical writing, leadership, and audit experience.
Pay: $80,000.00 - $110,000.00 per year
Benefits:
- 401(k)
- Health insurance
- Paid time off
Work Location: In person
