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

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.

- 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.

- 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.

- 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.

- 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.

- 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.

- Timely closure and effectiveness of CAPAs and investigations.

- 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.

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

Job Posting End Date: 08/18/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.