Associate Director, Quality Assurance

About CSBio

CSBio is a peptide contract manufacturing founded in 1993. Our initial products were a complete line of automated synthesizers for manufacturing and process development, with a focus on cGMP production. In 1994, we opened our custom peptide facility and began producing high quality compounds for research organizations and pharmaceutical companies worldwide. In 2004, we opened our peptide production facility in Menlo Park, CA and in 2014, we expanded our production capability through the addition of a new, state of the art building dedicated to cGMP peptide production. In 2017, we passed a FDA inspection and were recommended to be approved for commercial drug substance manufacturing. In 2023, we added additional cGMP clinical production capacity in Milpitas, CA.

Job Duties

• Host and provide responses to client audits and regulatory inspections.
• Oversee Quality Management System at CSBio encompassing quality investigations including Deviations, CAPAs, and oversee Document Control, Training and Customer Complaints.
• Provide direction and strategy to assess and remediate, as appropriate, current and previous validation documentation, including conducting gap assessments, risk assessments, and development of standards.
• Review / approve OOS, deviations, CAPAs, SOPs, and operation documents.
• Create and provide guidance on phase-appropriate processes and systems.
• Review and approve Risk Assessments, Process Development Reports, and Protocols.
• Quality oversight of the validation system to ensure quality and compliance requirements are met in an efficient and effective manner.
• Quality oversight and approval of validation related documentation (e.g., IQ, OQ, PQ, etc.); this includes process, facilities, utilities, equipment, test methods, cleaning and software validations.
• Work with Operations, Manufacturing, Quality Control, and Validation to establish, develop, communicate, and maintain a validation assessment plan for all GXP assets, buildings, systems, including laboratory instrumentation and systems.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Manage the recall process including initiation, customer and regulatory notification, and product withdrawal.
• Identify and manage continuous improvement projects with the objective of achieving quality and efficiency in processes.
• Manage, develop and mentor staff.

Competencies

Qualifications

Benefits

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