Senior Specialist, Quality Assurance - Non - sterile Product Quality Operations

Senior Specialist, Global Development Quality Operations

The Rahway based Senior Specialist, Global Development Quality Operations, is responsible for independent approval of documentation to support GMP clinical supply drug product 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 excipients, components, and critical supply items to ensure conformance to appropriate regulatory and company requirements. In support of clinical supply manufacture and/or regulatory 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. Issue reports summarizing results and work with area to ensure resolution of audit findings. Notifies relevant management of unresolved issues/trends.

Specific and/or additional duties may include, but are not restricted to:

• Advise supported areas on requirements for all assigned project responsibilities as related to quality and our company's standards and communicate project status to management.
• Act as Development Quality representative for in-house or outsourced manufacturing for clinical supplies. Duties include compliance oversight of program-related activities, batch record review and approval, deviation and/or out-of-specification approval, etc.
• Identify need for and/or develop SOPs to ensure practices are accurately reflected. Assist support areas in SOP and quality-related system development and approval.
• Represent Development Quality on inter-departmental and cross-functional teams, ensuring communication of information and providing quality guidance and/or deliverables.
• Independently prioritize work in support of multiple projects including clinical supply disposition commitments and maintenance of a cGMP posture within Global Development Quality.
• Support preparations for regulatory agency inspections. May accompany regulatory agency officials, conducting inspections of facilities or operations in supported areas, including GMP Certification inspection.

Education Minimum Requirement: B.S. in appropriate Science or Engineering discipline (chemistry, biology, biochemistry, microbiology); advanced degree preferred.

Required Experience and Skills: Minimum 5 years of experience in Pharmaceutical or related industry Experience in one or more functional areas such as quality control, quality assurance, analytical laboratories, manufacturing, production support area, clinical development. Strong leadership skills with the ability to lead teams of a cross-functional and multi-level nature, including senior management representatives. Excellent verbal and written communication including presentation skills. GMP or related drug regulation knowledge and expertise. Ability to independently manage multiple priorities and projects.

Preferred Experience and Skills: Experience in non-sterile and/or sterile drug product manufacture/testing. Experience in excipient/component release requirements/testing. Experience with manufacturing investigations and CAPA's. Familiarity with R&D or clinical supply areas and processes. Knowledge and competency in SAP. Experience with regulatory or QP inspections. Superior skills in collaboration, teamwork, and conflict management. Strong analytical problem-solving skills.

Notice: The position will initially be assigned to 1st shift (e.g., 7:00 AM–3:00 PM) through the end of 2025 and into 2026. The position is expected to transition to 2nd shift (e.g., 3:00 PM–11:00 PM) in 2026. Applicants should be willing and able to accept a schedule change at that time and thereafter, to work either shift. Reasonable notice of schedule changes will be provided.

Requirement: Must be able to work on first and second shift.

Required Skills: Accountability, Adaptability, Audits Compliance, Biochemistry, Chemistry, Clinical Development, Communication, Data Analysis, Detail-Oriented, Deviation Management, Employee Training Programs, GMP Auditing, GMP Compliance, Good Manufacturing Practices (GMP), Immunochemistry, Interpersonal Relationships, Manufacturing Processes, Manufacturing Quality Control, Microbiology, Molecular Microbiology, Physiology, Process Improvements, Quality Assurance (QA), Quality Assurance Systems.

Preferred Skills: Experience in non-sterile and/or sterile drug product manufacture/testing. Experience in excipient/component release requirements/testing. Experience with manufacturing investigations and CAPA's. Familiarity with R&D or clinical supply areas and processes. Knowledge and competency in SAP. Experience with regulatory or QP inspections. Superior skills in collaboration, teamwork, and conflict management. Strong analytical problem-solving skills.