Associate Director Quality Assurance
Associate Director Quality Assurance
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
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 phaseappropriate 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 problemsolving 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 everyones 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
- Bachelors 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 problemsolving and quality improvement tools and techniques
- Ability to work effectively and collaboratively in a crossfunctional team within a fastpaced environment
Benefits
- Medical dental and vision insurance (Kaiser HMO or BlueShield PPO. Employer pays 85 for Employee and 50 for Employees family; Dental: Aetna Dental Delta Dental Guardian Dental MetLife Dental. Vision: VSP and Aetna EyeMed)
- Basic life $20000 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
Required Experience:
Director
Employment Type
Full-Time
