Associate Director, Quality Assurance

CSBio • Milpitas, CA

2d

About The Position

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.

Requirements

• Bachelor’s Degree in Engineering, Life Sciences, Chemistry, or related field
• 8+ years in Quality Assurance in a pharmaceutical, medical device or drug manufacturing company with at least 4 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
• 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.

Responsibilities

• 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.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 11-50 employees