Manager, Quality Assurance

CSBio is a fast-paced peptide CMO 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 for commercial drug substance manufacturing. In 2019, we expanded into Milpitas, CA for non-clinical production and in 2022, completed our cGMP patient specific cancer vaccine peptide production facility.

We are seeking a qualified individual to join us as the Manager of Quality Assurance at our Menlo Park facility. This position reports to the Direct of Operations. Job responsibilities include the following:

• Support Quality Management System at CSBio encompassing quality investigations including Deviations, CAPAs, and oversee Document Control, Training and Customer Complaints.
• 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.
• Provide guidance on phase-appropriate processes and systems.
• Review and approve Risk Assessments, Process Development Reports, and Protocols.
• Provide Quality support for the validation system to ensure quality and compliance requirements are met in an efficient and effective manner.
• Provide 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.
• Identify and manage continuous improvement projects with the objective of achieving quality and efficiency in processes.
• Provide responses to client audits and regulatory inspections.
• Manage, develop and mentor staff.

Requirements

• Bachelor’s Degree in Engineering, Life Sciences, Chemistry, or related field
• 5+ years in Quality Assurance in a pharmaceutical, medical device or drug manufacturing company with at least 2 years of managing Validation and Quality Systems activities
• Strong GMP knowledge and in depth understanding of ICH and FDA regulations
• Thorough understanding of problem-solving and quality improvement tools and techniques
• Ability to work effectively and collaboratively in a cross-functional team within a fast-paced environment

Benefits

• Medical, dental, and vision insurance (Kaiser HMO or BlueShield PPO).
• 401k 10% 1:1 match
• PTO policy. 10 days PTO
• Holidays policy: 8 days floating PTO
• Additional companywide paid holiday during Summer Break (Week of July 4), Thanksgiving (Thursday/Friday) and Winter Break (Week of December 25)
• Carpool, clean air vehicle, and cell phone reimbursement
• Employee rewards and recognition program
• Company organized social events
• Catered lunch on all federal holidays
• Quarterly sponsored team building activities