Head of Quality
This job post is currently not available.
Esco Lifesciences Group, is Singapore’s most globalized life sciences company, with annual revenues
close to SGD 200M and global operations in over 20 countries across North America, Europe and Asia.
Esco Aster Pte Ltd is an affiliate of Esco Lifesciences Group and was first introduced in 2017.
At Esco Aster Pte Ltd, we are a contract development and manufacturing organization founded and
deeply rooted by scientists enabling fellow scientists to translate their bench work into commercially
available products and services at affordable prices.
The work we do creates a remarkable and lasting impact on our world. Join us as we redefine
healthcare for the current and future generations to come.
Esco Aster.
One World Biosolutions for One Health.
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 Head of Quality will report to CEO. The Head of Quality 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. The Head of Quality plays a crucial role in
ensuring the safety, efficacy, and quality of cell and gene therapy products manufactured within the
facility, while also fostering a culture of quality, compliance, and continuous improvement.
- 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.
- Maintain up-to-date knowledge of FDA, EU, ICH & country specific regulations , other
relevant guidance governing GxP activities and applicable ISO standards such as ISO13408
across the organisation.
- Facilitate the technology transfer of cell and gene therapy processes from research or
process development to manufacturing.
- Ensure that scale-up activities are conducted in a manner that maintains product quality and
consistency while meeting production 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.
- Oversight of and support major investigations, ensuring all product deviations are closed
prior to batch release.
- 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 cGMP 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].