Senior Specialist, Quality Systems

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 Sr. Specialist, Quality Systems, provides both strategic and hands-on leadership for GMP compliance programs, quality systems, and computerized systems. The incumbent will oversee and execute key quality and GMP activities to ensure inspection readiness and site compliance, while serving as the lead or process owner for one or more quality systems. They will also drive continuous improvement by monitoring site processes and influencing stakeholders on recommended compliance enhancements.

 Job Responsibilities

 Quality Systems & Compliance Site Support

• Act as a process owner of one or more quality systems (i.e., Deviation Management, Change Control, Quality Risk Management, Supplier/Client Complaints, etc.) across the site

• Manage QA to QA interactions with clients, including, but not limited to, quality event notifications and periodic meetings

• Assist in the maintenance and implementation of the Quality Systems

• Collaborate and influence other functions and teams to drive the continuous improvements activities and corrective and preventive actions

• Contribute to the training, education, guidance, and influencing of operational and support areas on quality and compliance policy and practices

• Develop and implement quality improvement programs and processes, and ensure management and employee quality responsibilities are met

• Review and approval of data and documentation created during quality activities to ensure consistency with company policies, procedures, and specifications

• Keep management team advised of significant issues or department trends during quality system reviews

• Prepare and present technical and quality system program information to management

• Assist in generating metrics for overall quality systems and identify continuous improvement opportunities

• Maintain a working knowledge of applicable regulatory requirements to ensure departmental compliance

• Formulate and maintain quality system objectives complementary to corporate policies and goals

• Focus on building effective working relationships throughout the organization to achieve business goals

• Collaborate with other Resilience sites and central functions to create standard quality systems requirements where possible. Work in partnership with the global process owner (where applicable) to ensure compliance with global policies

• Lead projects or actively participate on project teams related to compliance, quality systems, and continuous improvement initiatives across PETs, sites support groups, and cross-site groups

• Participate in quality risk assessment activities, where applicable

• Cross-train to provide back-up support for other roles under Compliance and Quality Systems

• Support site new product launch lifecycle by providing cGxP compliance guidance

• Manage / support the periodic revision and execution of the APQRs, Site Master File & Mock recall

• Manage/update ERP master data, where applicable

Inspection Readiness

• Support the preparation, planning, logistics, and execution of the self-inspections, mock inspections, and any other inspection readiness activities

• Actively support the Logistics Center and/or Inspection Room during an external audit / inspection

• Support the Internal Audit (Self-Inspect