Sr Manager (Deviations, CAPAs and Change Control

EPM Scientific; El Segundo (CA); On-site; USD 140,000 - 168,000; Full time

Job summary

A dynamic biotech company is seeking a Senior Manager for Deviations, CAPAs, and Change Control. This pivotal role focuses on ensuring quality and compliance in manufacturing processes, overseeing deviations and corrective actions. The ideal candidate will have extensive experience in GMP regulated environments and will lead initiatives to enhance quality systems. Join a team dedicated to innovative treatments for advanced cancers and infectious diseases, making a real difference in patient outcomes through cutting-edge research and development. This is an exciting opportunity to contribute to impactful projects in a collaborative and forward-thinking environment.

Qualifications

• 10+ years of experience in a GMP regulated Biologics or Pharmaceutical environment.
• Experience in 21 CFR 210/211 and 21 CFR 600/610 regulations.

Responsibilities

• Develop and implement effective Quality Systems programs for compliance.
• Lead investigations and CAPAs to successful resolution.

Skills

Quality Systems Management

Regulatory Compliance

Cross-Functional Leadership

Data Analysis

Continuous Improvement

Education

Bachelor's Degree in Life Sciences or Engineering

Master's Degree in Relevant Discipline

Tools

Electronic Quality Systems (DMS, LMS, QMS)

Job description

Sr Manager (Deviations, CAPAs and Change Control)

2 days ago Be among the first 25 applicants

This range is provided by EPM Scientific. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$140,000.00/yr - $168,000.00/yr

Direct message the job poster from EPM Scientific

Life Sciences Senior Recruitment Consultant

We are working with a dynamic and growing biotech company dedicated to developing innovative treatments for advanced cancers and infectious diseases. Our mission is to improve patient outcomes through cutting-edge research and development.

Position Overview

The Senior Manager, Deviations, CAPAs, and Change Control will play a critical role in ensuring the quality and compliance of our manufacturing processes. This position will oversee the management of deviations, corrective and preventive actions (CAPAs), and change control processes to ensure adherence to regulatory requirements and company standards.

Role Responsibilities

1. Develop and implement effective Quality Systems programs to ensure compliance with clinical and commercial regulatory requirements and standards.
2. Develop and implement training to complement the programs.
3. Manage system administration, support, mentorship, guidance, and training to cross-functional stakeholders.
4. Monitor programs to ensure consistent execution in compliance with the global procedure.
5. Track and trend quality data and provide reports to management, ensuring active record management for timely closure and resolution of actions.
6. Lead and support quality systems operational mechanisms.
7. Review and approve non-product related deviations, CAPAs, and change controls as needed.
8. Participate in or lead investigations, complaint responses, and CAPAs to successful resolution through collaboration with Manufacturing, Facilities, CXOs, QC, and Quality teams.
9. Participate in or lead Change Control strategy direction through collaboration with Manufacturing, Facilities, CXOs, QC, and Quality teams.
10. Perform periodic audits of the company's Deviation, CAPA, and Change Management systems.
11. Provide support and serve as Subject Matter Expert during audits and inspections.
12. Identify and lead continuous improvement initiatives related to Deviation, CAPA, and Change Management programs.
13. Participate in internal audits.

Qualifications

1. Bachelor's Degree in a life sciences or engineering discipline with 10+ years of experience in a GMP regulated Biologics or Pharmaceutical environment.
2. Master's degree in a relevant discipline with 8+ years of similar experience.
3. Experience in 21 CFR 210/211, 21 CFR 600/610, and 2001/83/EC.
4. 5+ years of experience with electronic quality systems (e.g., DMS, LMS, QMS).
5. Management experience leading cross-functional Quality projects preferred.
6. Experience in clinical and commercial pharmaceutical environments preferred.
7. Experience with Contract Manufacturing Organizations preferred.

If you feel you'd be a good fit for this role, please apply.

Additional Details

• Seniority level: Mid-Senior level
• Employment type: Contract
• Job function: Quality Assurance
• Industries: Pharmaceutical Manufacturing