Head of Quality

at  ESCO ASTER PTE LTD

THE OPPORTUNITY

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.

REQUIREMENTS

• 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.

OTHER PREFERRED EXPERIENCE(S) :

• 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 jobs@escoaster.com

• 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.