Associate Director, Quality Assurance
CSBio, Milpitas, CA, United States
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.
Position Summary
The Associate Director / Director, Quality Operations is a hands-on quality leader responsible for overseeing daily QA and QC operations while helping strengthen the quality systems, operating discipline, and cross-functional execution needed to support CSBio's growth as a contract manufacturing organization. This role is expected to operate above a pure manager level: the individual must be able to oversee core quality activities, partner effectively across functions, support audits and inspections, and help shape practical, scalable quality systems. At the same time, this person must stay close to the work by spending regular time in labs and manufacturing to understand how operations actually run and to ensure quality solutions are feasible for the business.
Key Responsibilities
Site Operations
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Provide oversight for daily QA and QC operations, including product and material release, stability programs, method lifecycle activities, deviations, investigations, CAPAs, complaints, internal audits, and inspection readiness activities. ·
Monitor execution, identify operational gaps, and help prioritize quality work across teams based on compliance risk, business needs, and operational realities. System Optimization ·
Support the design, implementation, and continuous improvement of core quality systems. ·
Ensure systems are compliant, practical, efficient, and usable for front-line teams; identify opportunities to simplify workflows, reduce inefficiencies, and improve adoption. Audit/Inspection Lead ·
Lead and independently host regulatory and client audits/inspections, serving as the primary quality representative and front-room lead for assigned audits and inspections. ·
Develop sufficient operational subject matter expertise across key areas beyond Quality, including Manufacturing, Facilities, Validation, and related support functions, so that within approximately 6 months the individual can confidently represent and defend these operations in front of FDA, EU, clients, and other auditors without over-reliance on others. ·
Lead audit and inspection follow-up, including drafting and driving effective responses, CAPAs, commitments, and remediation plans, and ensuring actions are completed on time and are operationally practical and sustainable. Hands-On Leadership ·
Model CSBio's expectation that leaders understand operations at a task level; to observe workflows, understand bottlenecks, and identify where quality or execution is breaking down. ·
Demonstrate willingness to roll up sleeves, dive into operational details, and help solve problems directly when needed; use firsthand operational knowledge to recommend practical solutions and realistic milestones. Team Development ·
Foster a culture of initiative, urgency, accountability, and continuous improvement within the QA and QC teams; ensure issues are surfaced early, discussed openly, and resolved with practical, sustainable solutions. ·
Provide coaching and support to team members and emerging leaders to strengthen operational understanding, problem solving, and execution. Growth Path This role is intended for someone who can operate as a strong quality operations leader now and grow into broader Director of Quality responsibilities over time. Progression will depend on demonstrated ability to lead QA and QC operations with increasing independence, translate operational knowledge into practical quality goals and milestones, shape and improve systems that fit CSBio's business model, support and eventually lead audits and inspections with confidence, and develop team capability across functions. Competencies : To perform the job successfully, an individual should demonstrate the following competencies: Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations. Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Supports everyone's efforts to succeed. Organizational Support - Follows policies and procedures; Completes tasks correctly and on time; Supports organization goals and values. Motivation - Sets and achieves challenging goals; Demonstrates persistence and overcomes obstacles; Measures self against standard of excellence. Adaptability - Adapts to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events. Requirements BS or MS in a scientific discipline such as Chemistry, Biochemistry, Pharmaceutical Sciences, Engineering, or related field. Typically 8–12+ years of progressive GMP quality experience in QA, QC, or Quality Systems within pharma, biotech, or CDMO environments. Prior leadership experience overseeing quality operations, quality systems, or major quality workstreams. Working knowledge of product and material release, deviations, investigations, CAPA, change control, internal audits, inspection readiness, and QA/QC operational workflows. Demonstrated ability to work effectively in a small, hands-on, fast-moving organization. Strong communication and collaboration skills across technical and non-technical functions. Experience with eQMS/LIMS and continuous improvement initiatives is preferred. Benefits Medical, dental, and vision insurance (Kaiser HMO or BlueShield PPO. Employer pays 90% for Employee and 75% for Employee’s family; Dental: Aetna Dental, Delta Dental, Guardian Dental, MetLife Dental. Vision: VSP and Aetna EyeMed) 401k 10% 1:1 match PTO policy. 10 days PTO Companywide paid holiday during: Week of July 4, Thanksgiving (2 days), Week of December 25Basic life ($20,000 paid by company) and supplemental life insurance (optional supplemental). Disability insurance 50% standard employer paid. Carpool, clean air vehicle, and cell phone reimbursement Employee rewards and recognition program Company organized social events Quarterly sponsored team building activities
Provide oversight for daily QA and QC operations, including product and material release, stability programs, method lifecycle activities, deviations, investigations, CAPAs, complaints, internal audits, and inspection readiness activities. ·
Monitor execution, identify operational gaps, and help prioritize quality work across teams based on compliance risk, business needs, and operational realities. System Optimization ·
Support the design, implementation, and continuous improvement of core quality systems. ·
Ensure systems are compliant, practical, efficient, and usable for front-line teams; identify opportunities to simplify workflows, reduce inefficiencies, and improve adoption. Audit/Inspection Lead ·
Lead and independently host regulatory and client audits/inspections, serving as the primary quality representative and front-room lead for assigned audits and inspections. ·
Develop sufficient operational subject matter expertise across key areas beyond Quality, including Manufacturing, Facilities, Validation, and related support functions, so that within approximately 6 months the individual can confidently represent and defend these operations in front of FDA, EU, clients, and other auditors without over-reliance on others. ·
Lead audit and inspection follow-up, including drafting and driving effective responses, CAPAs, commitments, and remediation plans, and ensuring actions are completed on time and are operationally practical and sustainable. Hands-On Leadership ·
Model CSBio's expectation that leaders understand operations at a task level; to observe workflows, understand bottlenecks, and identify where quality or execution is breaking down. ·
Demonstrate willingness to roll up sleeves, dive into operational details, and help solve problems directly when needed; use firsthand operational knowledge to recommend practical solutions and realistic milestones. Team Development ·
Foster a culture of initiative, urgency, accountability, and continuous improvement within the QA and QC teams; ensure issues are surfaced early, discussed openly, and resolved with practical, sustainable solutions. ·
Provide coaching and support to team members and emerging leaders to strengthen operational understanding, problem solving, and execution. Growth Path This role is intended for someone who can operate as a strong quality operations leader now and grow into broader Director of Quality responsibilities over time. Progression will depend on demonstrated ability to lead QA and QC operations with increasing independence, translate operational knowledge into practical quality goals and milestones, shape and improve systems that fit CSBio's business model, support and eventually lead audits and inspections with confidence, and develop team capability across functions. Competencies : To perform the job successfully, an individual should demonstrate the following competencies: Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations. Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Supports everyone's efforts to succeed. Organizational Support - Follows policies and procedures; Completes tasks correctly and on time; Supports organization goals and values. Motivation - Sets and achieves challenging goals; Demonstrates persistence and overcomes obstacles; Measures self against standard of excellence. Adaptability - Adapts to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events. Requirements BS or MS in a scientific discipline such as Chemistry, Biochemistry, Pharmaceutical Sciences, Engineering, or related field. Typically 8–12+ years of progressive GMP quality experience in QA, QC, or Quality Systems within pharma, biotech, or CDMO environments. Prior leadership experience overseeing quality operations, quality systems, or major quality workstreams. Working knowledge of product and material release, deviations, investigations, CAPA, change control, internal audits, inspection readiness, and QA/QC operational workflows. Demonstrated ability to work effectively in a small, hands-on, fast-moving organization. Strong communication and collaboration skills across technical and non-technical functions. Experience with eQMS/LIMS and continuous improvement initiatives is preferred. Benefits Medical, dental, and vision insurance (Kaiser HMO or BlueShield PPO. Employer pays 90% for Employee and 75% for Employee’s family; Dental: Aetna Dental, Delta Dental, Guardian Dental, MetLife Dental. Vision: VSP and Aetna EyeMed) 401k 10% 1:1 match PTO policy. 10 days PTO Companywide paid holiday during: Week of July 4, Thanksgiving (2 days), Week of December 25Basic life ($20,000 paid by company) and supplemental life insurance (optional supplemental). Disability insurance 50% standard employer paid. Carpool, clean air vehicle, and cell phone reimbursement Employee rewards and recognition program Company organized social events Quarterly sponsored team building activities