Product Release Leader
GSK
Zebulon, North Carolina
Full-Time
Competitive
OfficeManager
Business Introduction
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 to help make a positive impact on the health of millions of people. Our supply chain is not just core to our operations; it’s vital to bringing our innovations to patients as quickly, efficiently and effectively as possible. Technology is transforming how we manufacture medicines and vaccines, enabling us to increase the speed, quality and scale of product supply. We need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of smart manufacturing technologies including robotics, digital solutions and artificial intelligence to deliver for patients.
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.
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.
Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.
People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the appropriate Recruitment Staff by emailing us at - usrecruitment.adjustments@gsk.com
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/