Lead, Deviation Management & Quality Assurance

Madrigalpharma; Conshohocken (Montgomery County); On-site; USD 147,600 - 180,400; Full time

Benefits offered by this job

Flexible paid time off

Medical, dental, vision insurance

401(k) offerings

Job summary

Madrigalpharma is seeking a Senior Manager for Deviation Management within Quality Assurance in Conshohocken, PA. This role will be pivotal in managing deviation governance, ensuring compliance, and leading investigations related to quality assurance. Candidates should have a strong background in GMP QA/QMS and significant experience in deviation management.

The successful candidate will be part of a dynamic team focused on addressing metabolic diseases with a strong emphasis on quality and compliance. Competitive salary and benefits offered.

Qualifications

• Requires 7-10 years of experience in GMP QA/QMS with a strong focus on deviation/investigation.
• Demonstrated improvements in cycle time and investigation quality.

Responsibilities

• Own deviation management governance and ensure timely and compliant investigations.
• Drive performance management and maintain inspection readiness.
• Coach teams on investigation quality and establish standards for investigations.

Skills

Deviation governance

Investigation quality standards

Backlog management

Cross-functional leadership

Education

BS+ in Science / Engineering

Tools

Veeva Vault Quality (eQMS)

Job description

Madrigalpharma is seeking a Senior Manager for Deviation Management within Quality Assurance in Conshohocken, PA. This role will be pivotal in managing deviation governance, ensuring compliance, and leading investigations related to quality assurance. Candidates should have a strong background in GMP QA/QMS and significant experience in deviation management.

The successful candidate will be part of a dynamic team focused on addressing metabolic diseases with a strong emphasis on quality and compliance. Competitive salary and benefits offered.