Sr. Specialist, 880 Non Sterile Safety & Quality Compliance Operations (Onsite)

About this role

Job Description

Position Summary   The Senior Specialist, 880 Safety & Quality Compliance Operations, is responsible for establishing and sustaining a culture of safety, quality, and compliance across Building 880 FLEx Non-Sterile Operations, in partnership with the FLEx Non-Sterile Compliance, Safety & Quality Operations Lead. This role supports Building 880 in maintaining and continuously improving GMP compliance, safety performance, quality system governance, audit and inspection readiness, deviation and CAPA management, training compliance, risk management, and continuous improvement initiatives that support reliable execution of the clinical supply pipeline.  

The position partners closely with Production, Tech Ops Engineering, Process Engineering, Formulators, Quality, EHS, Supply Chain, and Site Leadership to ensure safe, compliant, and reliable execution of clinical manufacturing operations while continuously improving performance. The role applies technical expertise, influence, coaching, and systems thinking to embed safety and compliance into daily operations within Building 880.  

Key Responsibilities   Safety & Compliance Leadership   • Champion a strong safety culture and ensure adherence to site, corporate, and regulatory safety requirements within Building 880.  

• Build collaborative working relationships and effective communication with stakeholders across manufacturing, process engineering, analytical testing, quality assurance, regulatory, and related functions.  

• Support safety observations, incident investigations, risk assessments, and corrective action implementation.  

• Serve as the compliance subject matter expert for GMP manufacturing operations within Building 880 Non-Sterile Operations.  

• Support implementation of the clinical supply QMS through participation as a topic team member and/or subject matter expert.  

Quality Systems & Inspection Readiness   • Lead and support deviations, investigations, CAPAs, change controls, and risk assessments for Building 880.  

• Drive sustained audit and inspection readiness through routine compliance monitoring and self-assessments.  

• Partner with Quality, EHS, Engineering, and Operations to resolve compliance risks and prevent recurrence.  

• Support facility compliance, audit readiness, and continuous improvement through drafting, reviewing, and advising on deviations, investigations, change records, and related quality documents.  

Training & Procedural Governance   • Oversee SOP lifecycle management and procedural compliance within the facility.  

• Develop or update SOPs to ensure current practices are accurately reflected and support SOP and quality-related document approval as appropriate.  

• Monitor training and qualification status to ensure workforce readiness and compliance.  

• Support implementation of standardized work and best practices across non-sterile operations.  

Continuous Improvement   • Analyze safety and quality metrics to identify trends and improvement opportunities.  

• Apply Lean, MPS, and root cause problem-solving tools to improve operational performance and compliance outcomes.  

• Promote right-first-time execution and sustainable compliance practices.  

Required Qualifications   • Bachelor’s degree in Engineering, Life Sciences, Chemistry, or related discipline.  

• 4+ years of pharmaceutical or GMP manufacturing experience.  

• Experience with investigations, CAPAs, audits, and quality systems.  

• Strong knowledge of cGMPs, compliance requirements, and safety programs.  

• Strong communication, problem-solving, and cross-functional collaboration skills.  

• Excellent verbal and written communication skills, including presentation skills.  

• Demonstrated ability to manage projects and priorities to meet deliverables and timelines.  

• Strong attention to detail, flexibility, and awareness of production and associated quality issues.  

• Ability to work in a dynamic environment with rapidly changing needs.  

• Ability to work across functions and sites, and with all levels of staff and management.  

Preferred Experience and Skills   • Experience in drug product manufacture/testing.  

• Oral drug product knowledge and experience.  

• Knowledge of R&D or clinical supply areas and processes.  

• Experience with manufacturing investigations and CAPAs.  

• System knowledge of Veeva and SAP.  

Success Measures   • Safety performance improvement and risk reduction.  

• Audit and inspection readiness.  

• Timely closure and effectiveness of CAPAs and investigations.  

• Training and SOP compliance.  

• Reduction in recurring deviations and compliance events.  

• Sustained GMP compliance and operational excellence.  

Leadership Expectations   • Lead by example and foster a Safety First and Quality Always culture.  

• Drive accountability, continuous improvement, and compliance excellence across Building 880 Non-Sterile Operations.  

• Operate as a trusted partner and technical resource to the Associate Director and cross-functional stakeholders.  

• Demonstrate sound judgment, strong ownership, and a proactive approach to issue prevention and resolution.  

#eligibleforERP FLEx2026 #PSCS

Required Skills: Clinical Trials Operations, Cross-Functional Collaboration, Detail-Oriented, Engineering Processes, Equipment Qualification, GMP Compliance, Good Manufacturing Practices (GMP), Operational Excellence, Performance Improvements, Process Hazard Analysis (PHA), Process Optimization, Regulatory Compliance, Regulatory Compliance Consulting, Risk Analysis, Risk Assessments, Root Cause Analysis (RCA), Strategic Thinking, Technical Leadership, Technical Problem-Solving Preferred Skills:

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