Senior Specialist, Quality Systems

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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.

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This position resides in the Quality Systems & Compliance Team and provides strategic and tactical leadership to GMP compliance programs & processes, quality systems, and computerized systems. The incumbent will manage and execute required quality and GMP compliance activities to ensure compliance with GMPs and regulatory filling, providing inspection readiness of the site and maintaining the license to operate. Function as a lead/process owner of one or more quality systems across the site, including oversight responsibilities of the quality system's process, procedures, monitoring, and maintenance.

The incumbent will demonstrate proficiency in the Quality System of ownership and drive continuous improvements efforts through monitoring of site systems and processes against current compliance requirements and influencing key stakeholders on recommended compliance improvements

• Act as a process owner of one or more quality systems (i.e., Deviation Management, CAPAs, Change Control, Quality Risk Management, Quality Management Review, Quality Metrics, etc.) across the site
• 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
• Support the periodic revision of the APQRs & Site Master File
• Manage/update ERP master data, where applicable

• 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-Inspections) Program and drive corrective actions to completion
• Provide Quality Systems and Compliance's routine reports as required for support of regulatory documents, inspections, or focus teams
• Ensure compliance with regulatory filings and the documentation system at the site

• Considerable experience in pharmaceutical industry and QA
• Knowledge of pharmaceutical compliance, industry best practices, and a strong familiarity with production operations
• Knowledge of regulatory/cGMP requirements
• Excellent oral and written communication skills
• Strong ability and motivation to learn
• Good decision-making skills and judgment skills
• Ability to coach and mentor peers

• Bachelor's degree in a science/technical field such as pharmacy, biology, chemistry, or engineering
• Prior experience in quality assurance/regulatory compliance in the pharmaceutical industry
• Prior experience with regulatory inspections
• ASQ certifications (i.e., CQA or CQE)
• Member of pharmaceutical trade associations, such as ISPE or PDA

The items described here are representative of those that must be met successfully to perform the…