Reporting into the site's Quality Director, The Quality Compliance Lead ensures site operations consistently fulfil regulatory and quality agreement standards. This role requires strong leadership, proactive management and the ability to collaborate effectively across teams to maintain compliance, drive continuous improvement and ensure inspection readiness at all times.
Responsibilities
* Manage the registration process for new products and oversee the maintenance of existing licenses (including pharmaceuticals and medical devices) to ensure all regulatory requirements are met.
* Maintain Quality Agreements with GSK customers and third‑parties, aligning with regulatory and organisational standards.
* Focus on people management, succession planning and team development to ensure retention. Lead, train, coach and motivate the management team and employees towards continuous improvement, Good Manufacturing Practices (GMP), and provide development of direct reports and key talent within the Quality Compliance organization; creating a high‑performing team.
* Ensure effective product quality compliance via the management and oversight of Periodic Product Review (PPR) processes.
* Manage the site's internal inspection readiness programme (and associated activities) ensuring ongoing compliance with GMP standards.
* Maintain an independent programme of internal audits to identify and address compliance risks across the site.
* Develop and implement a framework to ensure all parts of the site remain inspection‑ready at all times, fostering a culture of quality awareness.
* Manage external and internal inspections, including preparation of data ahead of inspections and the organisation of the control room during inspection activities.
* Manage customer and vendor complaints processes to ensure timely investigation, resolution and communication of corrective actions.
* Establish and maintain effective Quality Governance systems (including the Quality Council) to ensure robust oversight of quality compliance and continuous improvement activities.
As this role is multi‑faceted and includes liaising with a wide variety of on‑site production and operations teams, you will be a self‑motivated person who has strong experience of working in regulatory or quality functions and/or manufacturing at a complex highly‑regulated manufacturing site. You should demonstrate knowledge/experience of inspection readiness (audit experience). You will be resilient and calm under pressure, have strong people skills and a proven ability to influence people to achieve objectives and drive performance. You will have a strong continuous improvement mindset. Effective written and verbal communication and excellent interpersonal skills, as well as the ability to organise and prioritise workload, are considered essential skills. Degree in a relevant scientific, technical or engineering discipline (or equivalent experience, ideally gained working in a Pharmaceutical Manufacturing Facility or similar highly‑regulated industry) is required.
Qualifications and Experience
* Relevant quality / compliance knowledge and experience.
* Management experience.
* Knowledge of current Good Manufacturing Practice (cGMP) requirements.
* Knowledge and application of Quality Management Systems (QMS).
* Knowledge of internal and external audit processes (e.g., inspection readiness & validation).
Benefits
* Competitive base salary.
* Annual bonus based on company performance.
* Opportunities to partake in on‑the‑job training courses.
* Opportunities to attend and partake in industry conferences.
* Opportunities for support for professional development and chartership.
* Access to healthcare and wellbeing programmes.
* Employee recognition programmes.
GSK offers a range of benefits to its employees, which include, but are not limited to: Competitive base salary; Annual bonus based on company performance; Opportunities to partake in on‑the‑job training courses; Opportunities to attend and partake in industry conferences; Opportunities for support for professional development and chartership; Access to healthcare and wellbeing programmes; Employee recognition programmes.
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), sexual orientation, disability, genetic information, military service or any basis prohibited under federal, state or local law.
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.
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