- About us
- People Like Me
- WISE Awards
- WISE Conference
BS or equivalent.
Experience in pharmaceutical/biologics regulatory, quality or scientific disciplines.
• Broad-based pharmaceutical experience with extensive understanding of the quality environment and compliance related expectations and processes; extensive knowledge of drug development and R&D – its strategy, objectives, customers, business units, processes and culture; demonstrated solid working understanding of strictly regulated environment.
• Proven understanding of quality management and assurance principles. Understanding of regulatory affairs, drug development and lifecycle maintenance activities. Demonstrated experience and capability in managing risk and risk treatment plans.
• Track record of managing and delivering projects, particularly in the areas of quality and compliance.
• Practical experience leading and implementing process development and improvement activities that embed quality and drive continuous improvement. Experience in process mapping and writing process documents.
• Flexible approach, readily adapting to changing circumstances and new opportunities; encourages, leads, facilitates and drives change where appropriate. Challenges and questions ways of working to seek improved processes.
• Excellent attention to detail. Able to rapidly assimilate, interrogate and understand complex data, and formulate risk-based, pragmatic quality driven solutions.
• Operates with independence, effectively communicating at all levels.
• Promotes a culture of trust and openness where colleagues and stakeholders are encouraged to openly contribute.
• Strong influencing and change management skills.
Develop and maintain an integrated quality and risk management program within GRA that:
• Embeds quality, risk management, and continuous improvement principles. Promotes development and sustainability of a continuous improvement quality culture framework and standards within GRA.
• Ensures appropriate and robust quality controls are in place and in use. Supports GRA in self-identifying quality issues and in managing/creating robust solutions. Ensures effective investigations and root cause analyses of issues are completed and appropriate Corrective and Preventive Actions are identified and implemented.
• Facilitates the conduct of Risk Assessments and the development of Risk Mitigation Plans, and monitors mitigation actions.
• Ensures delivery and embedding of corporate and R&D driven quality and compliance initiatives, in GRA.
• Facilitates inspection and audit readiness in GRA. Partners with Global Quality Assurance to support regulatory authority inspections as required within GRA.
You may apply for this position online by selecting the Apply now button.
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.