Senior Specialist, Quality Assurance; Hybrid

Senior Specialist, Global Development Quality Operations - API

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 in support of the company's clinical supply programs.

• Perform quality assurance activities related to API manufacturing in a complex, clinical supply development.
• Review and/or approve GMP documents.
• Ensure all API 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 communication of status to the Management Team.
• Build collaborative working relationships and effective communications with all stakeholders in manufacturing operations, analytical testing, quality assurance, regulatory, etc. at all levels.
• Establish, educate, and enforce standard operating procedures (SOPs) required under GMP.
• Develop/update SOPs to ensure practices are accurately reflected.
• 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 and/or quality subject matter expert.
• Proactively identify, execute and manage independent projects for continuous quality improvement and efficiency.
• Support the implementation of the clinical supply QMS through participation as topic team member and/or subject matter expert.
• 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.
• Escalate issues as needed.
• Provide meeting coordination, facilitation, scribing, and communication.
• Other duties as assigned by manager for the flexible functioning of the work group.

• Bachelor degree (B.S.) in an appropriate Science or Engineering discipline (engineering, chemistry, biology, biochemistry, microbiology).
• Minimum of 5 years’ experience with a B.S. degree.
• 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, regulatory.
• GMP or related drug regulation knowledge and expertise.
• 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 staff and management at all levels.
• Proficiency with Microsoft Suite (Word, Excel, PowerPoint, Teams).
• Ability to learn other electronic systems.

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

• Salary range: $106,200 - $167,200, based on education, qualifications, experience, and location.
• Eligible for annual bonus and long-term incentive, if applicable.
• Medical, dental, vision healthcare, and other insurance benefits for employee and family.
• Retirement benefits, including 401(k).
• Paid holidays, vacation, compassionate and sick days.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.

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