Business Process Manager

RESPONSIBILITIES: Oversee quality event investigations, including deviations, product complaints, and related follow-up actions. Coordinate corrective and preventive action (CAPA) plans, evaluate effectiveness, and support change control processes. Perform batch disposition reviews and maintain accurate, compliant quality records. Plan, lead, or participate in GMP audits and assist with regulatory inspection readiness. Provide quality assurance guidance to manufacturing-related development, CMC, and supply chain functions. Work with internal departments and external partners to identify compliance gaps and resolve quality concerns promptly. Adapt quality management and risk management plans to assigned programs, monitor execution, and recommend improvements. Assess quality data and operational risks, help establish mitigation measures, and communicate significant issues through appropriate channels. Advise clinical and operational teams on GCP, ICH guidance, internal procedures, and regulatory expectations. Serve as a key quality contact, contribute to stakeholder discussions, and prepare updates on trends, risks, and improvement initiatives. Support investigations of potential noncompliance and other quality concerns in coordination with relevant teams.

QUALIFICATIONS: Bachelor's degree or an equivalent combination of education, training, and relevant experience. Working knowledge of GMP quality activities, GCP, ICH guidelines, SOPs, and applicable regulatory standards. Understanding of pharmaceutical or clinical research operations, drug development, and domestic and international regulations. Familiarity with quality management systems, risk assessment, investigations, CAPA, and audit practices. Strong analytical judgment, problem-solving ability, organization, and attention to detail. Effective communication, relationship-building, negotiation, and influencing skills across teams and stakeholders. Proficiency with Microsoft Office applications and professional fluency in English. Ability to guide and motivate teams while working independently and collaborating across functions.

BENEFITS: Build expertise across GMP quality assurance, risk management, and regulated pharmaceutical operations. Gain exposure to cross-functional programs spanning quality, development, and supply chain activities. Collaborate with experienced stakeholders and contribute directly to quality improvements and compliance outcomes. Develop leadership and problem-solving capabilities through audits, investigations, and complex quality initiatives.