Quality Systems Manager
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.
Physical/Mental Requirements/Work Environment
- Ability to author, review and approve standard operating procedures and other related documents for compliance with established and new requirements.
- Ability to define problems, collect data, establish facts, and draw conclusions.
- Ability to focus regardless of circumstances and stress induced pressure.
- Ability to drive quality culture and promote compliance behaviors.
- Ability to take proactive approach.
- Ability to adapt for improvement and keep up to date on most current regulatory, local and international requirements and guidelines.
- Meticulous and systematic.
- Have strong focus on safety, quality and timeliness.
- Have strong critical thinking skills.
You will be part of Esco Aster Singapore’s Quality Leadership team and contribute towards the overall site mission and objectives. You will drive and manage the site’s Quality Systems to ensure smooth operations in compliance with GMP.
Primary work location: Ayer Rajah Crescent, Singapore
- Align the Quality Systems team to achieve the goals of the Quality Department and the Site; communicate the needs of the QS team to the Quality management.
- Lead and develop QS team members to build a self-managing and high performing team.
- Ensure Quality Systems are effectively implemented for the site, including but not limited to Deviation, Change control, CAPA, Document control, Training records, Complaints monitoring, Internal and External Audit, Supplier Management.
- Develop and maintain Quality Systems documentation and records.
- Continuously identify and drive improvement initiatives to Quality Systems to achieve business objectives.
- Provide subject matter expertise on Quality Systems and management in cGMP.
- Support the training of personnel on Quality Systems and their workflow and processes.
- Manage internal and external audits and inspections.
- Undertake tasks assigned by leaders as and when appropriate.
- Degree in relevant discipline.
- Minimum of 8 years’ experience in a cGMP pharmaceutical QS role, with at least 3 to 5 years in a supervisory role or similar capacity.
- Applicants with prior experience in QA/QC related roles with familiarity of Quality Systems may also be considered.
- Familiar with cGMP operations in drug products, and in drug substances (preferred).
- Familiar with working in a cGMP environment and keeping up to date with current cGMP, with flexibility to change as needed due to new regulatory requirements and technologies, as relevant for clinical and commercial supply.
- Experience with regulatory requirements such as FDA, EMEA etc.
- Proficient in MS Office Suite (Microsoft Word, PowerPoint, Excel).
- Able to work independently, self-starter, self-motivated and task oriented.
- Good communication skills and able to openly communicate and escalate any relevant issues.
- Experience in supervising and maintaining high performing team, whilst being a strong team player to work with both internal and external stakeholders.
- Develop positive relationship with a strong set of interpersonal skills and able to provide guidance and obtain buy in from all levels of organisation.
- During the start-up phase of the facility, be willing to take on expanded role to set up the team and workflow/processes as well as expanded scope as needed.
Apply now by submitting a Cover Letter and CV to [email protected].