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 20 countries, 8 manufacturing and R&D hubs in the US, Europe, the UK, China, Singapore, Indonesia, and over 1300 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.
The Quality Director will report to CEO, with dotted Line reporting to Plant Manager.
- Establish, Implement and Oversee Quality Management System, associated policies, procedures and documentation to ensure that the plant is in compliance with cGxP (GMP,GLP,GSP/GDP) as promulgated by international authorities such as USFDA, EU, WHO, and Singapore MOH.
- Ensure each batch of product has been manufactured, tested and approved for release in compliance with the applicable laws and regulations in force in the country of manufacture and applicable market authorisations.
- Review and approve Batch related documentation used in the manufacture of purified intermediates, drug substance, drug products.
- Approve the release of incoming materials, in-process materials and manufactured products for the plant
- Assess and approve the regulatory and quality requirements of technology transfer plans in consultation with customers.
- Manage the Quality Assurance functions, supervise and guide subordinates 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.
- Interface and communicate with Process Development, Production, Business Development and Quality Control to ensure that production batches are reviewed and released in a timely manner.
- Manage the issuing, retrieval and archival of eBatch Records and associated documentation.
- Perform routine Product quality review to identify risk factors with due consideration to cGMP training and personnel issues.
- Conduct Quality System reviews, on a regular basis, to ensure that the system is suitable, effective and that it satisfies the current required standards as well as continuous improvement.
- 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)
- Report the performance of the Quality System to the Management Committee for necessary review and improvements.
- 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.
- 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 - Senior QA Officer / QA Officer.
- Degree in Biotechnology/ Chemical Engineering/ Bioengineering/ Life Sciences or related studies.
- Minimum of 10 years in a cGMP biopharmaceutical or equivalent cell and gene therapy manufacturing related role with at least 5 years in a people management role.
- Proven track record in cGMP DS and DP.
- Applicant must be familiar with working in a cGMP environment with thorough understanding and keeping up to date with current cGMP whilst able to be flexible and work with regulatory to change as needed due to new regulatory standards and new technologies as relevant to the stage of clinical trial from phase 1,2 and 3 to commercial production.
- Understand and have executed six sigma black belt, lean manufacturing, JIT production, Kanban, Kaizen and other equivalent production systems.
- Strong technical writing abilities in being able to write from ground up SOPs and able to review as relevant to relevant ISPE/PDA, cGMP Guidelines and technical working documents especially as those that pertain to Single Use technologies.
- Able to work independently self-starter, self-motivated and task oriented.
- 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.
- 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].
For other job openings in Esco Lifesciences Group within the respective geographies, kindly refer to corporate website.