Product Release Leader

We manufacture and supply reliable, high-quality medicines and vaccines to meet patients’ needs and drive our performance. Our network of 37 medicines and vaccines manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024. Our supply chain is vital to bringing innovations to patients quickly, efficiently, and effectively. Technology is transforming how we manufacture medicines and vaccines, enabling increased speed, quality, and scale of product supply.

About the role

To provide operational quality support and oversight to all GMP areas including Oral Solid Dose (OSD), Metered Dose Inhaler (MDI), Multi-Dose Powder Inhaler (MDPI), Laboratories, Warehouse, and Facility/Utility areas. Ensure adherence to cGxP standards and procedures through independent oversight of GxP processes.

• Review and release products 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 escalations in all GMP operational areas.

Responsibilities

• Provide quality oversight for GMP areas including Oral Solid Dose, Metered Dose Inhaler (MDI), 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. Ensure 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 spot-checks of activities across defined GMP areas to ensure compliance with quality standards, including production, testing, cleaning, and maintenance activities. Ensure facilities are maintained in a good state in line with local housekeeping standards; escalate deviations and support timely implementation of remedial actions.
• Collaborate with cross-functional teams to resolve quality issues, implement corrective/preventive actions (CAPAs), and support continuous improvement efforts.
• Role model the GPS standards and foster a Quality Starts with Me (QSWM) culture by coaching employees on the importance of following procedures, doing the right thing, and explaining the impact non-compliance can have on product quality and patient safety.
• Communicate effectively with team members, escalate issues to production and quality teams, and provide on-call support as required.
• Create, review, and second-check certificates (CoA, CoC) in alignment with market requirements and GSK standards.

Requirements

• Bachelor’s Degree and 4+ years of GMP pharmaceutical experience.
• 4+ years of Pharmaceutical Manufacturing, Quality, QC experience or similar, with the ability 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.

Qualifications

• Bachelor’s degree in a scientific, engineering, or quality discipline.
• Ability to work independently and as a strong team player.
• Good knowledge of cGMPs and other regulatory requirements.
• Demonstrated initiative, critical thinking, analytical problem-solving skills, and ability to build strong collaborative relationships across the organization.
• Excellent organizational skills, attention to detail, adaptability to change, and ability to prioritize work effectively to meet expectations.
• Flexibility, adaptability, and alignment with GSK Values, Behaviors, and Strategies.
• Sound knowledge of pharmaceutical compliance requirements and ability to interpret and translate them to the site environment.
• Proficiency with IT applications (e.g., MERP, Microsoft Office, Power BI, VQD).
• Strategic thinking and demonstrated collaboration, negotiation, and conflict resolution skills.
• Well-developed interpersonal skills, decision-making capabilities, and 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.

Schedule

This role requires 100% on-site presence for hands-on release activities and inspections. Some nights and weekends will be expected.

Benefits

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

About the 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:

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

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