Business Process Manager

SUMMARY

Seeking a quality professional to strengthen GMP compliance and quality oversight across pharmaceutical development and supply activities. This individual contributor will collaborate with cross-functional teams, provide guidance on quality risks, and help implement quality management practices that support regulatory compliance and continuous improvement.

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.