Position Summary

To provide operational quality support and oversight to all GMP areas including Oral Solid Dose (OSD), Metered Dose Inhaler (MDI) and Multi-Dose Powder Inhaler (MDPI), Laboratories, Warehouse, and Facility/Utility areas.

• Ensure adherence to cGxP standards and procedures through the independent oversight of GxP processes.
• Review and release products that are manufactured and/or packaged in compliance with local and regulatory requirements
• Improve the effectiveness of quality in preventing /identifying and addressing quality issues by enabling a strong quality culture and leading continuous improvement efforts
• Maintain presence and be accountable for quality decision-making and quality escalations to all GMP operational areas

Responsibilities
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

• Provide quality oversight for GMP areas including Oral Solid Dose, Metered Dose Inhaler (MDI) and Multi-Dose Powder Inhaler (MDPI), Laboratories, Warehouse, and Facility/Utility areas.
• Maintain presence across area of responsibility and be the first line of contact to support initial management of quality issues. Accountable for quality decision making via work order assessments, atypical comments, and initial impact assessment for deviations.
• Responsible for review, release and second check of batch record documentation for compliance to cGMPs, SOPs, and internal and regulatory requirements. Also ensuring that all GMP documentation and records follow Good Documentation Practice (GDP) by adhering to ALCOA++ principles for data integrity through both review and end-user support.
• Provide timely guidance during GMP activities to proactively detect potential quality issues through active observation in real-time, allowing for timely interventions to prevent deviations and defects. Support and/or lead problem solving / root cause analysis and CAPA identification.
• Perform a spot-check of activities across defined GMP areas to ensure compliance with quality standards that includes production, testing, cleaning and maintenance activities. Check that facilities are being maintained in a good state in line with local housekeeping standards and any deviation from the standards are escalated and support timely implementation of remedial actions.
• Collaborate with cross-functional teams to resolve quality issues, implement corrective/preventive actions (CAPAs) and support and/or lead continuous improvement efforts.
• Check that facilities are being maintained in a good state in line with local housekeeping standards and any deviation from the standards are escalated and support timely implementation of remedial actions.
• Role model the GPS standards and foster a Quality Starts with Me (QSWM) culture by providing coaching to employees on the importance of following procedures, doing the right thing and explaining the why and the impact non-compliance can have on product quality and patient safety.
• Communicate effectively with team members, escalate issues to production and quality team/lead and provide on call support as required.
• Create, review and second check certificates (CoA, CoC) in alignment with market requirements and GSK standards.

Why You?

Work arrangement
This role will require 100% on-site for hands-on release activities and inspections. Some Nights and Weekends will be expected wit this role.

Basic Qualification
We are seeking professionals with the following required skills and qualifications to help us achieve our goals:

• Bachelor's Degree and 4+ years of GMP pharmaceutical experience
• 4+ years of Pharmaceutical Manufacturing, Quality, QC experience or similar and able to apply Quality Management Systems (QMS) and GMP principles to day-to-day role.
• Experience working with quality systems such as deviations, CAPA, change control, and document control.

Preferred Qualification
If you have the following characteristics, it would be a plus:

• Bachelor's degree in a scientific, engineering, or quality discipline.
• Must be able to work independently, but also be a strong team player.
• Good knowledge of cGMP's and other Regulatory requirements.
• Demonstrate initiative, think critically, analytical problem-solving skills and build strong collaborative relationships across the organization.
• Excellent organizational skills and attention to detail while being able to adapt to change; ability to prioritize work effectively to deliver to expectations.
• Must be flexible, adaptable and a strong team player that fosters and promotes GSK Values, Behaviors and Strategies.
• A sound knowledge of pharmaceutical compliance requirements and the ability to interpret and translate to the Site environment.
• Proficient with IT applications, i.e. MERP, Microsoft Office, Power BI, VQD.
• Ability to think strategically.
• Demonstrated collaboration, negotiation and conflict resolution skills .
• Well-developed interpersonal skills and decision-making capabilities with the ability to resolve conflict and influence different levels of the Site and Quality organization.
• Ability to deliver clear communications (both verbally and written), coach others, foster a Quality Starts with Me (QSWM) culture and work with a spirit of continuous improvement.

About the Zebulon Site

GSK's Zebulon site is a global supplier of Respiratory and Solid Dose medicines to patients around the globe and the largest GSK Pharmaceutical secondary manufacturing site in North America. The site is located less than 30 minutes from downtown Raleigh, Wendell, Knightdale, Rocky Mount, Wilson, and Wake Forest.

Key differentiators about GSK and Zebulon:

• Our commitment to inclusion is seen as a critical advantage of ours
• Our focus on cultivating a positive work environment that cares for our employees
• Demonstrated opportunities for continued career growth driven by individual ambition
• Leaders that care about their teams and growth of both individuals and the company
• A priority focus on Safety and Quality
• Clean and GMP compliant work environment
• Onsite cafeteria
• Onsite gym
• Temperature-controlled climate
• Licensed, onsite Health & Wellness clinic

What we value
We look for people who act with integrity, put patients first, and work well with others. We welcome applicants from different backgrounds and encourage people who bring varied perspectives to apply. If you are ready to grow your career, deepen your release expertise, and make a real impact on patients, please apply and tell us how your experience fits this role.

Skills
Data Integrity, Detail-Oriented, Digital Fluency, GxP Regulations, Influencing Without Authority, Lean Management, Pharmaceutical Regulatory Compliance, Problem Solving, Quality Assurance (QA), Risk Awareness, Technical Writing

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.