Associate Director, Quality Assurance

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:

• 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.

• 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

• Medical, dental, and vision insurance (Kaiser HMO or BlueShield PPO. Employer pays 85% for Employee and 50% for Employee’s family; Dental: Aetna Dental, Delta Dental, Guardian Dental, MetLife Dental. Vision: VSP and Aetna EyeMed)
• Basic life ($20,000 paid by company) and supplemental life insurance (optional supplemental).
• Disability insurance 50% standard employer paid.
• 401k 10% 1:1 match
• PTO policy. 10 days PTO
• Companywide paid holiday during: Week of July 4, Thanksgiving (2 days), Week of December 25
• Carpool, clean air vehicle, and cell phone reimbursement
• Employee rewards and recognition program
• Company organized social events
• Quarterly sponsored team building activities