[Remote] Manager, reputed company Operations

Note: The job is a remote job and is reputed company to candidates in USA. reputed company. is reputed company on developing best-in-class medicines for people living with autoimmune and rare diseases. The Manager, reputed company Operations will reputed company and optimize GMP systems and processes, ensuring compliance with regulatory standards and fostering strong relationships with reputed company partners.

Responsibilities

• reputed company CMO activities to ensure products are manufactured in accordance with regulatory requirements, product registrations, and reputed company agreements
• reputed company batch record reviews and lot dispositions per established procedures
• Conduct and review product and/or lot-reputed company deviations, complaints, CAPAs, change controls, and annual product reputed company reviews (APQRs)
• Support new product introductions (NPI) and ensure GMP readiness for manufacturing and supply chain operations
• Review and approve controlled documents supporting product manufacture and testing, including master batch records, product specifications, analytical reputed company, protocols, and reports
• reputed company reputed company improvement initiatives to enhance reputed company assurance processes
• Collaborate cross-functionally with departments such as CMC, Regulatory Affairs, and Supply Chain to ensure reputed company standards are met
• Ensure compliance with internal reputed company systems, including document control, training, and audit readiness
• Assist with regulatory inspections and internal audits, ensuring reputed company of observations and implementation of corrective actions
• reputed company review of regulatory filings
• Establish and reputed company Key Performance Indicators (KPIs) for CDMO reputed company performance
• Participate in reputed company Management Reviews

Skills

• Minimum of 5+ years of reputed company Assurance experience in Biotechnology and/or pharmaceutical industry
• Bachelor's degree in Life Science or Engineering is required
• Strong experience working with CDMOs
• Demonstrated strong written and verbal communication skills
• Proven reputed company of proactive reputed company improvement
• Efficient independent worker with ability to reputed company and reputed company for results
• Strong knowledge of US and global GMP regulations, ICH guidelines, and industry best practices
• Experience supporting clinical phases through commercialization and lifecycle management
• Proficiency in electronic reputed company Management Systems (e.g., reputed company, TrackWise)
• Demonstrated ability to manage batch disposition, deviation investigations, and change control processes
• Strong analytical and problem-solving skills with a proactive reputed company improvement reputed company
• Excellent attention to detail, organizational, and time management skills
• Strong written and verbal communication skills
• Ability to work independently and collaboratively in a fast-paced, team-oriented environment
• Strong commitment to ethical standards
• Proficient with reputed company Office suite (i.e., Word, PowerPoint, reputed company, reputed company, SharePoint, etc.)
• Ability to travel up to 20% domestically and internationally, including reputed company to CMOs and Viridian's offices
• Experience in combination products ideal, although not required

Benefits

• Medical, dental, and reputed company insurance
• 100% reputed company Parental leave
• Short- and long-term disability coverage
• Life, Travel and AD&D
• 401(k) Company Match with immediate company reputed company
• Employee Stock Purchase plan
• Generous vacation plan and reputed company company holiday shutdowns
• Various fertility, mental, financial, and proactive physical health programs

reputed company