QA Manager, Manufacturing Quality Operations

About Bora Bora Pharmaceuticals is a premier international contract development and manufacturing organization (CDMO) specializing in formulation development, clinical and commercial manufacturing, and packaging of complex oral solid dose, liquid, semi-solid, biologics, and sterile injectable pharmaceutical products. From our world-class sites in North America and Asia, we deliver drug products with unparalleled quality to more than 100 markets around the world.

Bora’s teams, technologies, and facilities work seamlessly together to enable our clients to deliver much-needed therapeutics to patients worldwide. At Bora Pharmaceuticals, we see it as our mission, our duty, our responsibility, to make our success and our customer’s success more certain.

Leads routine Quality Assurance oversight of commercial pharmaceutical manufacturing and packaging operations. Provides day-to-day GMP support across shop-floor operations, batch-record review, investigations, CAPA execution, complaint support, product disposition, and production escalations. Provides leadership and technical direction to Product Quality Specialists, Quality Associates, and the site Training team. Owns the site GMP training system, including curriculum governance, assignment and completion controls, learning management system administration, qualification programs, training effectiveness, metrics, and inspection support.

Ensures continued Quality support after products transition from project mode into steady-state commercial operations and partners across Operations, Technical Services, Quality Control, Engineering, Client & Project Quality, Quality Systems, and functional management. Develops and trends operational, QMS, compliance, supplier-quality, computerized system validation, and training metrics to support management review and continuous improvement.

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. Provides direct supervision, performance management, coaching, resource planning, scheduling, workload prioritization, and professional development for Product Quality Specialists, Quality Associates, and the Training team. Provides daily QA support and shop-floor or operational Quality coverage for commercial manufacturing and packaging activities. Oversees review and approval of executed batch records and routine master batch records, logbooks, procedures, and other GMP documentation supporting commercial operations.

Manages manufacturing and packaging deviation records, investigation support, root-cause evaluation, approval, and timely completion in accordance with the Quality Systems process. Reviews operational CAPAs, monitors follow-up, and verifies that actions are implemented and supported by appropriate evidence. Assesses manufacturing and packaging changes for product, process, validation, documentation, and compliance impact and executes change records within the governed change-control process. Owns final product disposition for routine commercial products after confirming completion and compliance of applicable batch documentation and quality records.

Manages routine complaint investigation support, including coordination of operational evidence, root-cause analysis, corrective actions, and documentation;
Client & Project Quality supports significant client communications and relationship escalations. Manages production-related Quality escalations and provides timely, risk‑based Quality decisions and resource coordination. Owns the site GMP training system and directly oversees the Training team, including needs assessment, curriculum governance, training assignment and completion controls, LMS administration, training effectiveness, qualification programs, metrics, and inspection support. Partners with functional managers, who remain accountable for ensuring their personnel complete required training and apply training in job performance.

Develops, reviews, trends, and reports QMS, compliance, supplier-quality, CSV, and training metrics for management review and continuous improvement. Develops, reviews, and reports operational quality metrics, workload indicators, deviation performance, batch-review status, complaint performance, and disposition status. Accepts products into routine commercial Quality support after documented transfer‑to‑operations readiness criteria are met and maintains ongoing product quality support thereafter.…