Resilience · 9 hours ago
Senior Specialist, Quality Systems
West Chester, OH
Full-time
Onsite
Mid, Senior Level
$80K/yr - $118K/yrResilience is a technology-focused biomanufacturing company that’s changing the way medicine is made. They are seeking a Senior Specialist in Quality Systems to provide strategic and tactical leadership to GMP compliance programs, manage quality systems, and ensure compliance with regulatory requirements.
BiopharmaBiotechnologyHealth CareLife SciencePharmaceutical
No H1B
Responsibilities
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
Qualification
Required
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
Preferred
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
Benefits
Annual cash bonus program
401(k) plan with a generous company match
Great healthcare (including medical, dental and vision)
Family building benefits
Life and disability insurance
Flexible time off
Paid holidays
Other paid leaves of absence
Tuition reimbursement
Support for caregiving needs
Company
Resilience
Resilience is a biomanufacturing company that provides access to complex medicines and protects biopharmaceutical supply chains.
Founded in 2020
1001-5000 employees
Funding
Current Stage
Late StageTotal Funding
$3.36BKey Investors
Oak Hill AdvisorsAdministration for Strategic Preparedness and ResponseMubadala
2025-10-29Debt Financing· $825M
2024-10-03Grant· $17.5M
2023-03-24Debt Financing· $410M
Leadership Team
William Marth
President & Chief Executive Officer
Susan Billings
Chief Commercial Officer (CCO)
Recent News
Help Net Security
2025-11-11
2025-11-05
Company data provided by crunchbase