ACCELERATING YOUR FUTUREThe 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.
How You Will Make an Impact:- 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.
Compliance/Investigations/Quality Systems
- 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, 6Ms.
- Ensure investigations are scientifically sound, technically accurate, and completed within established timelines.
- Partner with appropriate SMEs to assess impact to product quality, compliance, and patient associated with quality events.
- Support establishment of the appropriate KPIs for the operational team and partnering to make sure they are met.
Partnership and Collaboration
- 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.
Continuous Improvement
- 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.
Technical Leadership
- Provide technical mentorship and coaching on investigation practices, root cause analysis, and GMP compliance.
- Influence quality and operational decisions through scientific, risk-based, and data-driven recommendations.
- Serve as a Qualified Trainer for deviation and investigation writing.
- Foster a proactive culture of compliance, continuous improvement, and operational excellence.
- Demonstrate sound judgment, accountability, and professionalism while managing multiple complex priorities in a dynamic GMP environment.
What You Will Bring:- Strong technical expertise in GMP quality systems and cell therapy manufacturing operations.
- Demonstrated ability to lead complex investigations using structured root cause analysis and risk-based decision making.
- Excellent analytical and critical thinking skills with the ability to interpret technical and manufacturing data to identify trends and systemic issues.
- Strong technical writing skills with experience authoring deviations, investigations, CAPAs, change controls, and SOPs.
- Ability to perform and lead risk assessments using FMEA/FASEP methodologies is a plus.
- Exceptional organizational skills with the ability to prioritize and manage multiple complex activities in a fast-paced GMP environment.
- Excellent interpersonal, verbal, and written communication skills with the ability to collaborate effectively across Operations and Quality organizations.
- Proficiency with Microsoft Office Suite (Excel, Word, PowerPoint) and electronic Quality Management Systems (eQMS).
Qualifications:- Bachelor's degree in Life Sciences, Engineering, Biotechnology, Biomedical Engineering, Microbiology, or a related scientific discipline with 8+ years of relevant industry experience, or a Master's degree with 5+ years of relevant industry experience.
- Minimum 5 years of experience leading quality system activities, including deviations, investigations, CAPAs, and change controls in a regulated GMP environment.
- Demonstrated experience leading complex technical investigations involving manufacturing processes, equipment, facilities, materials, or documentation.
- Experience partnering cross-functionally with Manufacturing, MS&T, Quality Assurance, Validation, Engineering, and Supply Chain.
- Experience supporting regulatory inspections, client audits, and inspection readiness activities is preferred.
- Lean Six Sigma, Quality Risk Management, or formal root cause analysis training is desirable.
Final compensation will be based on a variety of factors, including education, experience, technical expertise, specialized skill sets, market demand, internal equity, and business needs.
At RoslinCT, we offer more than just competitive pay. Our comprehensive Total Rewards package is designed to support your health, financial well-being, and professional development throughout your career. Benefits include medical, dental, and vision insurance, educational assistance, a 401(k) program, and a variety of additional resources to help you thrive both personally and professionally.
Department MS and T Locations Hopkinton Yearly salary $80,000 - $110,000 Employment type Full-time
