Senior Compliance Specialist, Operations

RoslinCT is a world-leading cell and gene therapy contract development and manufacturing organization creating cutting-edge therapies that change people’s lives. Collaborative, dedicated, and talented people are the backbone of our culture, working both autonomously and in driven teams to make life-changing products utilizing ground-breaking science.

Here at RoslinCT, our team can contribute to the development of revolutionary treatments. We live every day by our core values:
Partner Focus, One Team, Personal Growth, Integrity, Innovation, and Trust and Respect. We put our employees at the forefront by providing a flexible and empowering work environment, an attractive benefits package, and an emphasis on work-life balance. Our people are the key to our success. At RoslinCT we focus on developing our corporate culture, people’s development, growth, and the ability to impact patients.

The Senior Compliance Specialist is responsible for ensuring the timely and compliant execution of investigations, deviations, CAPAs, change controls, and continuous improvement initiatives in support of GMP cell therapy operations.

• Serve as the Operations compliance subject matter expert, supporting GMP manufacturing and operational activities across the site.
• Drive timely and effective execution of quality system activities to ensure compliance with regulatory requirements, company procedures, and client expectations.
• Partner with Operations leadership to identify compliance risks and implement sustainable solutions that improve quality, efficiency, and inspection readiness.
• Build strong cross-functional relationships with Manufacturing, MS&T, Quality Assurance, Validation, Engineering, Supply Chain, and other Operations functions to support compliant execution.
• Utilize quality metrics and trend analysis to identify opportunities for continuous improvement and operational excellence.

• Lead complex deviations, investigations, CAPAs, Change Controls, and Effectiveness Checks for Operations.
• Conduct thorough root cause investigations utilizing risk-based problem-solving methodologies including Ishikawa, 5 Whys, 6
  
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• Ensure investigations are scientifically sound, technically accurate, and completed within established timelines.
• Partner with appropriate SMEs to assess impact to product quality, compliance, and patientassociated with quality events.
• Support establishment of the appropriate KPIs for the operational team and partnering to make sure they are met.

• Partner with Quality Assurance to ensure consistent execution of GMP quality systems across Operations.
• Collaborate with Manufacturing, MS&T, Validation, Engineering, and Supply Chain to resolve quality issues and implement effective corrective actions.
• Maintain inspection readiness by ensuring quality system records are complete, accurate, and audit ready.
• Support internal audits, client audits, and regulatory inspections as the Operations subject matter expert. Manage implementation of Operations CAPA/commitments from audit/inspection responses.
• Prepare investigation summaries, responses, and supporting documentation for audits and regulatory inspections.
• Provide guidance on GMP requirements, quality risk management, and quality system expectations to Operations personnel.
• Identify opportunities to improve quality system effectiveness, investigation quality, and compliance processes.
• Support Quality Systems with deploying improvements to the eQMS as an operational SME by providing input training materials and SOP updates
• Analyze deviation and investigation trends to drive systemic improvements under CAPA or OE initiatives.
• Support implementation of Lean and Quality Risk Management principles within Operations.
• Participate in cross-functional initiatives focused on operational excellence, compliance, and process optimization.
• Recommend and implement improvements that reduce recurring quality events and strengthen quality culture.

• Provide technical mentorship and coaching on investigation practices, root cause analysis,…