Senior Specialist, Quality Assurance; Hybrid

Senior Specialist, Global Development Quality Operations – API

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 in support of our company's clinical supply programs. This person will also independently approve documentation accompanying the disposition of API materials to ensure conformance to appropriate regulatory and company requirements.

In support of clinical supply manufacture and/or inspections independently perform or coordinate routine and specialized audits of batch documentation, data, information, procedures, equipment and systems, and/or facilities to ensure compliance with Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMPs) and other applicable worldwide regulations and our Company's requirements.

Primary responsibilities include but are not limited to the following:

• 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, as required, 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 all 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.

Education

Minimum Requirements:

• 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.

Required

Experience and Skills:

• Experience in the pharmaceutical or closely related industry.
• Experience in one or more functional areas such as quality assurance, analytical laboratories, manufacturing, production support area, 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, to meet deliverables and timelines.
• Attention to detail, flexibility, and an awareness of production and associated quality problems.
• Ability to work in a dynamic environment with…