Senior QA Lead - Batch Release & Disposition

Resilience; Port Union (OH); On-site; USD 95,000 - 144,000; Full time

Benefits offered by this job

Annual bonus

401(k) plan

Health benefits

Paid vacation

Paid holidays

Life insurance

Job summary

Resilience is seeking a Manager, QA Batch Disposition, to lead the batch release and disposition activities. You will oversee the batch disposition team, ensure GMP documentation quality, and liaise with clients on batch-related matters.

The role includes managing QA reviews, training personnel, and driving continuous improvement across PETs. You will champion patient safety, ensure regulatory compliance, and partner with cross-functional teams to maintain product quality and timely releases.

Qualifications

• Experience in a position of people leadership.
• Advanced knowledge of cGMP requirements, quality systems, and pharmaceutical manufacturing/packaging technologies.
• Ability to influence leaders in a matrix environment and make courageous decisions to ensure patient safety and safeguard the company's reputation.

Responsibilities

• Lead batch release team during disposition of batches and review GMP documentation.
• Provide QA support for internal and external projects and interface with customers for issue resolution.
• Maintain strong client relationships to meet project timelines, product quality, and GMP compliance.
• Collaborate with Manufacturing Operations and support functions to sustain batch disposition operations.
• Direct and develop Quality professionals supporting batch disposition.
• Oversee QA review and approval of GMP documents and records impacting disposition.
• Release incoming materials (bulk, APIs, excipients, packaging components).
• Develop and maintain understanding of production processes and QA systems within PETs.
• Support site safety and lead team safety initiatives.
• Coach and develop staff, ensuring fair and equitable workplace practices.
• Promote consistent quality culture across PETs and sites.

Job description

Resilience is seeking a Manager, QA Batch Disposition, to lead the batch release and disposition activities. You will oversee the batch disposition team, ensure GMP documentation quality, and liaise with clients on batch-related matters.

The role includes managing QA reviews, training personnel, and driving continuous improvement across PETs. You will champion patient safety, ensure regulatory compliance, and partner with cross-functional teams to maintain product quality and timely releases.