Senior Specialist, Quality Assurance; Hybrid

Job Description

The Rahway-based Senior Specialist, Global Development Quality Operations – API is responsible for independent approval of documentation to support Good Manufacturing Practice (GMP) clinical supply API manufacture, testing, release, and maintenance. This role also approves documentation accompanying the disposition of API materials to ensure conformance to regulatory and company requirements. In support of clinical supply manufacturing and/or inspections, the specialist performs or coordinates routine and specialized audits of batch documentation, data, procedures, equipment, systems, and facilities to ensure compliance with SOPs, GMPs and applicable worldwide regulations.

• Perform quality assurance activities related to API manufacturing in a complex clinical supply development environment and review and/or approve GMP documents.
• Ensure all API is manufactured in compliance with cGMP and regulatory filings.
• Perform independent quality review and approval of batch records, testing data, and related documents required to release or reject product; make independent batch release or reject decisions.
• Conduct independent auditing, review, and approval of diverse and complex document types—including deviations, investigations, change records, analytical method validations, method transfers, analytical methods, specifications, certificates of analysis, etc.
• Accountable for all assigned projects and communicate status to the Management Team.
• Build collaborative working relationships and effective communication with all stakeholders across manufacturing operations, analytical testing, quality assurance, regulatory, and other departments.
• Establish, educate, and enforce standard operating procedures (SOPs) required under GMP.
• Develop/update SOPs and assist in SOP and quality‑related system document approval.
• Support metrics by summarizing findings during documentation reviews.
• Collect, prepare and analyze data to support quality system metrics and planning.
• Support compliance activities such as site readiness, audits, inspections, and CAPAs.
• Support quality risk management activities as facilitator, project lead or quality subject matter expert.
• Proactively identify, execute and manage independent projects for continuous quality improvement and efficiency.
• Represent Development Quality on inter‑departmental and cross‑functional teams, ensuring communication of information and providing quality guidance and/or deliverables.
• Exercise broad judgment in making quality decisions and solving complex problems; escalates issues as needed.
• Provide meeting coordination, facilitation, scribing, and communication.
• Other duties as assigned by manager.

• Bachelor degree (B.S.) in an appropriate Science or Engineering discipline (engineering, chemistry, biology, biochemistry, microbiology) and a minimum of 5 years of experience.

• Experience in the pharmaceutical or closely related industry.
• Experience in one or more functional areas such as quality assurance, analytical laboratories, manufacturing, production support, equipment/facilities management, or regulatory.
• Knowledge and expertise in GMP or related drug regulation.
• Strong leadership, collaboration, teamwork, negotiation, communication, problem‑solving, and workload management skills.
• Excellent verbal and written communication including presentation skills.
• Demonstrated ability to manage projects, priorities, and meet deliverables and timelines.
• Attention to detail, flexibility, and awareness of production and associated quality problems.
• Ability to work in a dynamic environment with rapidly changing needs.
• Ability to work across functional areas and sites, with all levels of staff and management.
• Proficiency with Microsoft Office (Word, Excel, PowerPoint, Teams) and ability to learn other electronic systems.

• Experience in small molecule API manufacture/testing.
• Small molecule API knowledge and experience.
• Knowledge of R&D or clinical supply areas and processes.
• Experience with manufacturing and analytical investigations and CAPAs.
• System knowledge of Veeva, SAP.