Sr. Specialist Manufacturing

Role: Senior Specialist Manufacturing focusing on technical leadership for complex investigation cases within biopharma manufacturing. Responsibilities: lead high-impact deviation investigations, guide investigation teams, ensure compliance and regulatory readiness, and implement continuous improvement initiatives leveraging advanced digital tools and data analytics. Collaborate across Manufacturing, Quality, Engineering, and Regulatory functions; represent the organization during audits and inspections; drive standardization and best practices across sites. Qualifications: High school diploma with 12+ years, or an associate's with 10+, bachelor's with 6+, master's with 4+, or doctorate with 2+ years in Quality or Manufacturing within GMP environments. Preferred: expertise in deviation management, root cause analysis, CAPA, experience interacting with regulatory agencies, and strong communication skills. High-Value: emphasis on GMP-compliant investigation processes, cross-functional problem-solving, digital and AI-enabled tool adoption, and a focus on operational excellence in biopharma manufacturing, with a broad impact across multiple therapeutic areas. Work setup details and travel expectations are not specified.