Product Release Leader

GSK•Zebulon, NC

5d•Onsite

About The Position

You will release product that is manufactured and/or packaged in compliance with regulatory agencies’ requirements and company standards. Provide quality oversight to Zebulon Production, Technical and Logistics departments to ensure their activities are in compliance with regulatory agencies’ requirements and company standards.

Requirements

High school diploma plus 8 years' experience in the pharmaceutical industry or associate's degree plus 6 years' experience in the pharmaceutical industry or BS/BA degree with 4 years' experience in the pharmaceutical industry in Quality.
2+ years of experience in lot release, batch record review, or quality operations in a regulated life sciences environment.
Experience working with quality systems such as deviations, CAPA, change control, and document control.

Nice To Haves

Bachelor’s degree in a scientific, engineering, or quality discipline.
Proven ability to communicate and influence at most levels of management.
Strong understanding and application of DI principles.
Ability to function in an atmosphere of constant change with detailed accuracy.
Excellent understanding of Microsoft Office suite products and MERP for batch release, due date monitoring, and information gathering.
Knowledge and application of the principles of Quality Management Systems (QMS).
Knowledge of cGMP - FDA and other Regulatory requirements.
Knowledge of Pharmaceutical Processes.
Demonstrated knowledge of continuous improvement methodologies.
Demonstrated collaboration, negotiation & conflict resolution skills.
Ability to multi-task & handle tasks with competing priorities effectively.
Technical aptitude (i.e. able to read & comprehend technical documentation & execute procedures).

Responsibilities

Provides support to the batch document review, release, and second check process to ensure that products released to market have been manufactured and packaged in accordance with cGMP and meets company specifications/requirements prior to release.
May perform batch document review activity when required and actively performs release activities.
Coordinates investigations associated with production deviations.
Participates in investigations to provide the quality views on the root cause and CAPA determinations.
Closes Planned (PR) Notifications associated with site and production activities.
Provides quality support to production through Rapid Response and Root Cause Analysis investigations for Quality Incidents in operations, involving operators, to ensure full understanding of the incident at the time it occurred.
Partners with the compliance, validation and technical teams, as needed, to agree remedial actions during/after production issues.
Agrees personal objectives from the quality strategy, develops oneself, acts as a coach and mentor when required to support the development of others, and assists with New Employee training.
Communicates effectively with team members and production ensuring quality issues are addressed and, if required, escalated in a timely manner to team lead.
Participates in and supports self-inspections, internal audits and regulatory inspections acting as quality SME for quality processes, batch documents and deviations.
Approves GMP related documentation such as master batch documents, SOPs/Forms and approves any changes associated with these documents.
Supports/Leads the delivery of business benefits through the continuous improvement framework and works with the team lead to establish lead and lag measure to track improvements.
Supports certificate (CofA, CofC) creation, review and second check verification in alignment with market requirements and GSK standards.
Attends flow/tier meetings to ensure product release activities are aligned to the business needs and delays are clearly communicated for assessment of impact as well as provides on-call support, as needed for the business.