Purpose
The Senior Quality Program Lead is responsible for ensuring seamless integration and alignment of projects within Quality department. This role ensures that site improvement plans, site quality plans and CAPEX projects are executed effectively, continuous improvement practices are implemented while fostering stakeholder collaboration and maintaining compliance with regulatory requirements. This role will work closely with the site leadership team and cross-functional teams to drive quality excellence and support the company's strategic objectives with strong project management skills and deep understanding of quality assurance processes.
Responsibilities
1. Leadership and project management
- Develop and execute quality strategies associated with site CAPEX projects of new product introduction in alignment with site strategic objectives and departmental goals.
- Support the site leadership team and quality director to foster a culture of quality, compliance, and continuous improvement across the site.
- Monitor project progress and ensure timely delivery of project milestone with appropriate resource allocation.
- Provide mentoring and coaching to enhance quality team competencies and performance.
2. Stakeholder Engagement
- Collaborate with cross-functional teams including R&D, manufacturing, engineering, supply chain, and regulatory affairs as well as external engineering, procurement, construction management teams.
- Ensure the quality standards are adhered to and communicated clearly to project team and to be a liaison between stakeholders and senior management where required.
- Provide quality expectations to ensure team members understand and adhere to quality standards.
3. Compliance Management
- Ensure all quality processes and systems comply with regulatory requirements (e.g., FDA, EMA, GMP), including inspection readiness of CAPEX projects.
- Assist in conducting compliance inspections and reviews to identify areas for improvement.
- Develop and implement corrective and preventive actions (CAPAs) to address compliance issues.
- Stay updated on regulatory changes and incorporate them into quality systems.
4. Continuous Improvement
- Identify opportunities for process improvements and lead initiatives to enhance quality and efficiency.
- Implement continuous improvement methodologies such as GPS and Quality Leadership experience.
- Track and report on the impact of improvement initiatives and share best practices across the organisation.
5. Risk Management
- Identify, assess, and mitigate risks related to product quality, compliance, and operational performance.
- Develop and implement risk management plans and strategies to minimise potential impacts in site CAPEX projects or quality related projects or programs.
- Ensure robust quality risk management processes are in place and regularly reviewed
Knowledge, Skills, and Experience
Professional
- Minimum degree in engineering or life sciences
- Minimum 10 years of experience in pharmaceutical production environment
- Min 5 years of experience in quality management
Technical
- Excellent knowledge of FDA / EU and international regulatory requirements, GMP guidelines and inspections.
- Strong knowledge of cGMP.
- Scientific understanding of pharmaceutical processes, where applicable, advanced knowledge in vaccine manufacturing or biological products
Business
- Proficiency in continuous improvement methodologies (e.g. Lean, Six Sigma).
- Strong analytical skills and ability to make data-driven decisions.
- Excellent leadership, communication, and interpersonal skills to engage stakeholders at all levels.
- Strong problem-solving skills and ability to address complex challenges.
- Ability to work effectively in a fast-paced, dynamic environment.
- Strong project management skills, with experience managing multiple complex projects simultaneously. Proven track record of driving process improvements and achieving quality goals.
To learn more about Singapore GSK and our people, please click on this link: https://www.linkedin.com/company/glaxosmithkline/life/gsksingapore
#Li-GSK
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
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.
