This job post is currently not available.
Esco Lifesciences Group provides enabling technologies, products and services to the life sciences and healthcare industries, supporting academic research and scientific discoveries, clinical practice, as well as biopharmaceutical R&D and manufacturing. Headquartered in Singapore, Esco has an extensive sales network in over 100 countries, direct sales and service offices in over 24 countries, 8 manufacturing and R&D hubs in the US, Europe, the UK, China, Singapore, Indonesia, and over 1500 employees worldwide.
Esco is poised to benefit from the sustained growth of the healthcare and biopharma industries in Asia and globally. Esco has achieved market leadership in China, and globally, in multiple categories within some of the fastest-growing segments — with China being its largest and fastest growing market. As a Singapore-headquartered company, Esco is a nexus of East and West, bridging technologies, products and talent across the world, with global operations spanning the US, Europe and Asia.Esco is poised to benefit from the sustained growth of the healthcare and biopharma industries in Asia and globally. Esco has achieved market leadership in China, and globally, in multiple categories within some of the fastest-growing segments — with China being its largest and fastest growing market. As a Singapore-headquartered company, Esco is a nexus of East and West, bridging technologies, products and talent across the world, with global operations spanning the US, Europe and Asia.
Physical/Mental Requirements/Work Environment
- Ability to focus, define problems, collect data, establish facts, draw conclusions and provide strategic plans and solutions.
- Ability to establish and improve Quality culture and be a role model for Quality.
- Ability to adapt and keep up with rapid changes in a fluid and dynamic environment as this is a rapidly evolving space
The Quality Director will report to CEO. The Quality director will be responsible for establishing, implementing and continuous improving all QA and QC systems and functions for Esco Aster Operations. He / She will successfully manage and direct the activities of Quality, and Regulatory functions including Quality Assurance, Compliance, Quality Systems, Quality Control, Sterility Assurance and Regulatory Affairs. This position requires an experienced and entrepreneurial leader that will develop Quality strategies, make decisions based upon relevant data and Good Manufacturing Practices (GMPs). This position will hold the site and team responsible for meeting commitments and enhancing customer experience. Esco Aster requires the successful candidate to lead the quality department and acts as a member of the Site Leadership team to provide the overall direction and guidance to the Quality organization.
- Provide Quality oversight and governance via an effective Quality Management System (QMS) to ensure proactive compliance in Esco Aster and Health Authority GxP requirements, and to meet business expectations.
- Ensure that regulatory controls are in place in relevant process steps as well as adherence to GxP, legal and company internal regulations for manufacturing, control and distribution operations and to EHS guidelines and requirements.
- Ensure each batch of product has been manufactured, tested and approved for release in compliance with the applicable laws and regulations.
- Host all Regulatory inspection and liaise and with regulatory bodies such as HSA, FDA, EMA etc.
- Represents the company in quality, compliance and safety matters. Partner with SLT to establish and champion Quality Culture and cultivate a customer focused organization.
- Set strategy and direction for Quality organization in alignment with Esco Aster’s vision and business goals.
- Ensure the Quality department has the right personnel, resource, and planning. These include hiring, on-boarding, developing and coaching employees and succession planning.
- Advises executive management on quality issues that may affect the Company, establish and report Quality KPIs to monitor the business and respond to underperformance.
- Manage the Quality Assurance functions, supervise and guide Quality department employees to ensure efficient and compliant operations in both technical and administrative aspects.
- Serve as a subject matter expert to guide the plant in the appropriate performance of compliance procedures.
- Plan, coordinate and execute internal and external quality audits and ensuring appropriate corrective actions and preventative are implemented in a timely manner as well as root cause analysis.
- Ensure the plant is in a audit ready state for all audits (internal, collaborator, and regulatory bodies)
- Assist on the intellectual properties portfolio of Esco Aster as it pertains to Quality ( in conjunction with legal or plant manager)
- Prepare and manage department budget.
- Drive cross-divisional standardization and efficiency gains through innovation and operational excellence projects.
- Full authority for the Quality Systems and cGMP implementation and improvements.
- Authority to approve changes made to the Quality System.
- Authority to approve the release of purified intermediates, drug substance, drug products.
- QC issues - QC Manager.
- QA issues – QA Manager
- Degree in Biotechnology/ Chemical Engineering/ Bioengineering/ Life Sciences or related studies. Advanced degree would be preferred.
- Minimum of 10 years in a cGMP biopharmaceutical or cell and gene therapy manufacturing in the Pharmaceutical Industry across Quality Commercial / Quality / Operations / Manufacturing / Development with expert understanding of GxP regulations from major Health Authorities and at least 5 years in a people management role.
Extensive knowledge of cGMPs and pharmaceutical manufacturing, Quality Control and Quality Assurance. Knowledge of regulatory requirement including Singapore HSA EMA and US FDA.
Experienced in Regulatory submissions and registration, Product Lifecycle and product portfolio management.
Expert understanding of GMP especially in CAPA Management, Quality Audit and Risk Management.
Leadership experience, good stakeholder management skills coupled with strong communications skills.
Experience in the development and implementation of Quality Management Systems incl. Compliance & Auditing and dealing with Health Authorities.
Experienced Change campaigner in a GMP setting due to new regulatory standards and new technologies.
Strong technical abilities and able to review relevant ISPE/PDA, cGMP Guidelines and technical working documents especially as those that pertain to Single Use technologies.
Experience in applying different RCA methods, tools principles and designing effective Corrective Action and Preventive Action as it pertains to Aseptic processing.
Good communication skills and openly communicate any relevant issues able to act as whistleblower when needed to act as gatekeeper.
Experience in developing, leading, and maintaining high performing team with strong emphasis on risk assessment whilst being a strong team player to work with both internal and external stakeholders as well as with regulatory.
Experience with European QP methodologies.
Understand and have executed six sigma black belt, lean manufacturing, JIT production, Kanban, Kaizen and other equivalent production systems.
Positive relationship with a strong set of interpersonal skills able to provide guidance and obtain buy in down to operator level on quality principles.
User experience with software tools on ERP and MES, Track & Trace, GLP Lab Notebook.
Proficient in MS Office Suite (Microsoft Word, Microsoft PowerPoint, Microsoft Excel).
Excellent written and verbal communication skills.
Apply now by submitting a Cover Letter and CV to [email protected].