QA Manager Regional Quality PDx

Position: QA Manager Regional Quality PDx, USA
Job Description Summary Develop and maintain systems, rules, and processes to ensure fulfillment of internal and external requirements. Ensures that projects and products are capable and will meet specified standards (Preventive). Has in-depth knowledge of best practices and how own area integrates with others; has working knowledge of competition and the factors that differentiate them in the market

Job Description Leadership & People Management Lead, coach, and develop Regional Quality team members supporting the U.S. market, ensuring operational excellence, regulatory compliance, customer focus, and effective execution of Quality responsibilities.

Drive engagement, clarity, accountability, and strong cross-functional collaboration across a geographically dispersed organization.

Foster a strong Quality and compliance culture across internal operations and external distribution partners.

Regional Quality & Compliance Oversight Provide Quality leadership and governance for U.S. Regional Quality activities, with primary focus on radiopharmaceutical products and distribution operations, and support Contrast Media as needed.

Provide oversight of the regional Quality Management System and ensure alignment with the Global QMS and applicable U.S. regulatory requirements.

Ensure compliance with applicable FDA requirements, cGMP, GDP (distribution requirements), product-specific controls, state requirements where applicable, and company Quality standards.

Provide Quality oversight across the product distribution lifecycle, including receipt, storage, handling, transportation, distribution, returns, recalls, and disposition activities, as applicable.

Ensure appropriate oversight of time- and temperature-sensitive radiopharmaceutical distribution, including maintenance of required product handling and distribution controls.

Identify, assess, communicate, and escalate Quality and compliance risks to regional and business leadership.

Radiopharmaceutical Distribution Quality Provide Quality oversight for the distribution of radiopharmaceutical products within the U.S. market, including internal operations, distribution locations, logistics providers, and other outsourced activities.

Ensure distribution processes maintain product quality, integrity, traceability, security, and compliance throughout the supply chain.

Oversee Quality requirements related to transportation, temperature excursions, distribution deviations, product complaints, returns, recalls, and other distribution-related Quality events.

Partner closely with Supply Chain, Operations, Regulatory Affairs, Pharmacovigilance, Medical, Commercial, and other functions to ensure effective management of Quality risks.

Support qualification, monitoring, and Quality governance of third-party logistics providers, distributors, suppliers, and other external partners.

Support Contrast Media distribution and Quality activities as required based on business priorities and regional needs.

Quality System Performance & Continuous Improvement Establish and monitor regional Quality objectives, KPIs, trends, and performance metrics.

Ensure timely and effective investigation, documentation, approval, and closure of deviations, CAPAs, complaints, change controls, temperature excursions, and other Quality records.

Ensure effectiveness of corrective and preventive actions and identify recurring or systemic Quality issues through trending and management review.

Drive simplification, standardization, and continuous improvement of Regional Quality processes.

Participate in global and regional Quality initiatives and share best practices across the Pharmaceutical Diagnostics organization.

Inspection & Regulatory Readiness Maintain inspection readiness for U.S. Regional Quality and distribution activities.

Support and participate in regulatory inspections, internal audits, supplier/distributor audits, and other Quality assessments.

Represent Regional Quality during interactions with regulatory authorities and other external parties, as appropriate.

Ensure observations, nonconformities, and audit findings are appropriately investigated and corrective actions are completed effectively and on time.

Quality Governance & Business Partnership Serve as a senior Quality partner to U.S. Regional, Supply Chain, Operations, Regulatory, and Commercial leadership.

Provide independent Quality oversight and appropriate escalation of significant Quality, compliance, product, or distribution risks.

Balance regulatory and Quality…