Manager, Quality Assurance (Batch Release)

A career at Resilience is more than just a job – it’s an opportunity to change the future.

Resilience is a technology-focused biomanufacturing company that’s changing the way medicine is made. We’re building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need. 

For more information, please visit www.resilience.com

Position Summary

The QA Manager (Batch Release) will be accountable for all batch release and disposition activities. These activities include building and maintaining batch release processes, client liaison, final batch documentation archival, sharing batch and release documentation with clients, ensuring key batch disposition metrics are achieved, team management, and overseeing all aspects of batch release operations. This role will oversee and provide guidance and leadership to the batch release team tasked with providing direction during the disposition of the batches and review of corresponding GMP documentation. The Quality Assurance Manager will develop a robust batch disposition process for different process nodes, develop training of QA personnel, and be responsible for client communication related to batch disposition.

Job Responsibilities

• Manage and provide guidance and leadership to the batch release team tasked with providing direction during the disposition of the batches and review of corresponding GMP documentation.  
• Ensures QA support for internal and external projects and team meetings. For significant issues, interfaces with customers and internal groups for resolution of quality issues. Develops good working relationships with clients and ensures appropriate and timely responses to client inquiries.
• Maintain strong partnerships with clients to ensure that project and delivery timelines and expectations for product quality and GMP compliance are met.
• Maintain strong collaboration with the Manufacturing Operations teams and other support functions that support batch disposition operations
• Provide direction, development, and performance management to the Quality professionals supporting batch disposition.
• Accountable for the QA review and approval of the following GMP documentation and records that have a direct impact on batch disposition activities:
  • Change Management (Change controls)
  • Batch Release decisions and material disposition
  • Quality Investigations (Deviations, supplier deviations)
  • Support Technical Transfers, Validation Plans, Protocols, and other technical reports
  • Standard Operating Procedures & Risk Assessments
• Accountable for the release of incoming materials (bulk, APIs, excipients, packaging components, and so on.)
• Develops and maintains a high level of understanding of the technical production process and quality systems being utilized within the Process Execution Teams (PETs)
• Support the site to ensure a safe working environment, including leading your team's safety efforts.
• Manage, coach, and assist with employee development and performance management; ensure a fair and equitable workplace 
• Collaborates with other managers and Quality professionals from other PETs (including other sites) to ensure consistent application of the key quality systems across all PETs
• Interfaces with the Site Support Groups on improvement projects (capital and noncapital) that impact the PET, and proactively ensure GMP compliance during the planning, execution, and closeout phases of these projects.
• Work cross-functionally with the area process teams for metrics reviews, operational support, and issue/deviation management
• Ensures the disposition process aligns with QAA and compliance with all GMP and regulatory requirements
• Ensures that the QA processes including batch record review, product disposition, and quality issues resolutions are executed to maintain the flow of products and documents to meet organization objectives
• Foster a strong quality culture including maintaining open communications and promoting teamwork and employee participation in the workgroup

Minimum 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, as well as the personal conviction to make courageous decisions to ensure patient safety and safeguard the company's reputation.

Preferred Qualifications

• Five years of experience in supervisory/managerial roles within QA in the Pharmaceutical Industry