Overview

CSBio is a peptide contract manufacturing company founded in 1993. This posting is for the role of Associate Director Quality Assurance. Base pay range is $125,000.00/yr - $175,000.00/yr. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

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 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

• 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

• 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

Benefits

• Medical, dental, and vision insurance (Kaiser HMO or BlueShield PPO). Employer pays 85% for Employee and 50% for Employee's family; Dental and Vision details vary by plan
• Basic life ($20,000) and optional supplemental life insurance
• Disability insurance 50% standard employer paid
• 401k 10% 1:1 match
• PTO policy: 10 days PTO
• Companywide paid holidays
• Carpool, clean air vehicle, and cell phone reimbursement
• Employee rewards and recognition program
• Company organized social events and quarterly team-building activities

Location: Santa Clara, CA

Job function: Science

Industry: IT Services and IT Consulting