GMP Quality Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Act as the Quality Assurance representative on interdisciplinary project teams.

• Liaise with Quality and Production departments at both domestic and international contract manufacturing organizations.

• Work collaboratively with SMPA's Quality, Supply Chain, CMC, and Commercial Manufacturing divisions.

• Perform product release activities for both clinical and commercial drug substances and products.

• Review and authorize Master Batch Records, Executed Batch Records, release and stability testing documentation, as well as batch disposition.

• Complete release processes promptly to ensure uninterrupted product supply while guaranteeing product quality and safety.

⛳️ Requirements

• A minimum of 8 years of experience is required, with significant experience in the biotech or pharmaceutical sector, particularly in a Quality role.

• In-depth knowledge of GMP manufacturing and/or market release of pharmaceutical dosage forms and/or combination products.

• Experience in managing external CMOs, contract laboratories, and third-party logistics providers.

• Proven experience in reviewing and approving master and executed batch records and executing final disposition of drug substances and products.

• Demonstrated experience in managing quality events, including investigations, CAPA, and change control.

• Familiarity with formal risk management tools and assessments.

• Capability to evaluate and assess technically complex quality events.

• Strong technical writing skills.

• Experience in enhancing GMP-related quality systems, policies, and procedures to ensure adherence to evolving standards and improve workflow efficiency.

• Exceptional ability to analyze complex issues and develop relevant, practical plans, programs, and recommendations.

• Excellent verbal and written communication skills, with the ability to engage effectively with senior management, partners, and core project team members.

• Self-driven, adaptable, and capable of prioritizing tasks and managing multiple assignments in a fast-paced environment while maintaining high quality and compliance standards.

• Bachelor's degree in a scientific discipline (e.g., biology, chemistry, engineering, pharmacy) or a related field of study.

🏝️ Benefits

• Competitive salary and compensation package.

• Opportunities for professional development and career advancement.

• Comprehensive health and wellness benefits.

• Collaborative and innovative work environment.