Senior QA Batch Release Lead

Resilience US, LLC; Olde West Chester (OH); On-site; USD 95,000 - 144,000; Full time

Benefits offered by this job

Annual cash bonus

401(k) with company match

Healthcare (medical, dental, vision)

Family building benefits

Life and disability insurance

Paid vacation

Paid holidays

Other paid leaves of absence

Tuition reimbursement

Caregiving support

Job summary

Resilience, Inc. is seeking a Manager, QA Batch Disposition to lead the batch release team and oversee all GMP documentation related to disposition. You will ensure client communications, maintain disposition metrics, and partner with manufacturing and QA teams to uphold quality and compliance.

The role requires strong leadership, deep cGMP knowledge, and experience with batch release processes. Collaboration with cross-functional teams and a focus on data-driven quality improvements are

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.
• Five years of supervisory/managerial roles within QA in the Pharmaceutical Industry.
• Experience with batch release and disposition.
• Demonstrated problem-solving and decision-making skills.

Responsibilities

• Manage and provide guidance and leadership to the batch release team during disposition of batches and review of GMP documentation.
• QA support for internal and external projects and meetings; escalate issues with customers and internal groups.
• Develops good working relationships with clients and ensures timely responses to inquiries.
• Maintain strong partnerships with clients to meet project delivery timelines and product quality/GMP standards.
• Collaborate with Manufacturing Operations and other support functions to support batch disposition operations.
• Provide direction, development, and performance management to QA professionals supporting batch disposition.
• Review and approve GMP documentation impacting batch disposition, including change management, batch release decisions, deviations, and tech transfers.

Skills

People leadership

cGMP knowledge

Matrix influence

Education

Advanced degree or Bachelor's

Job description

Resilience, Inc. is seeking a Manager, QA Batch Disposition to lead the batch release team and oversee all GMP documentation related to disposition. You will ensure client communications, maintain disposition metrics, and partner with manufacturing and QA teams to uphold quality and compliance.

The role requires strong leadership, deep cGMP knowledge, and experience with batch release processes. Collaboration with cross-functional teams and a focus on data-driven quality improvements are