Khim Nyang Tan Email & Phone Number

Sydney, New South Wales, Australia

Globally responsible for security and operations at NoahFace, spearheading information security efforts and achieving as well as maintaining SOC2 certification. End-to-end management of processes from strategic thinking to hands-on implementation, applying systems that are fit-for-purpose and suitable for the size and complexity of the organization.

Sydney, New South Wales, Australia

- Passed SOC 2 Type 2 and ISO 27001:2022 certification within 6 and 10 months of company inception, respectively. Auditor’s comment: Easiest and smoothest audit in his experience so far.- Established an Information Security Management System (ISMS) from the ground up, in conjunction with team leads, creating the most suitable process with minimal checkbox exercises. The standards were implemented sensibly, instead of blindly following the letter of the law, with automated processes established where possible.- Monitored threats and risks, working with the engineering team to mitigate risks. Received Wiz Zero Critical Club achievement upon full implementation of Wiz monitoring.- Performed periodic access reviews, management reviews, risk assessments, and other recurring activities as required for certifications.- Distilled user requirements, performed market research, evaluated relevant third-party vendors, and selected best cost/benefit choices for information security activities: compliance platform (Vanta), cloud monitoring and prevention (Wiz), external audits and pen testing (Prescient Security), MDM (Mosyle), etc.- Trained the company on certification requirements: SOC 2, ISO 27001, HIPAA.- Established and tested Disaster Recovery/Incident Response plan, as appropriate for the company.- Subject Matter Expert (SME) for customer inquiries for privacy, regulations, and compliance questions.- Took on the role of systems administrator and managed system access in accordance to principle of least privilege (PoLP), including Google Cloud Platform (GCP) Identity and Access Management (IAM), Github, Jira/Confluence, etc.- Took over HR and recruitment roles, and successfully recruited 2 candidates for 2 roles, managing the recruitment process and performing initial screening interviews.- Gained familiarity with Software Development Life Cycle (SLDC) process and basic platform engineering, including Terraform modules.

Sydney, New South Wales, Australia

- Developed a QMS from the ground up, tailored to SaMD requirements.- Delivered ISO13485 training, customized to the relevance of each department.- Developed SOPs in conjunction with team leads, creating the most suitable process with minimal checkbox exercises.- Automated ways of records generation and archiving, reducing need for manual handling.- Tested and executed a systems migration/split within 2 months for a company acquisition, with minimal issues.

Sydney, New South Wales, Australia

Key Achievements:- Achieved ISO 9001:2015 certification within 4 months.- Built up the worldwide QA team when business scaled-up 10-fold.- Established & maintained key QMS processes (Document Control, Vendor Management, CAPAs, etc.), emphasizing practicability and scalability.- Managed customer audits and follow-ups, resulting in successful engagement of major clients.Responsibilities & Milestones:- Selected & implemented a Learning Management System (LMS) via a rigorous vendor selection process, including a detailed User Requirement Specification (URS), review of 20+ solutions in the market, and seamless data migration from the old LMS to the new LMS. - Facilitated updates of 200+ SOPs for all departments to ensure that the SOPs are current, lean, and easy to read.- Managed & facilitated 180+ non-conformances/CAPAs from initiation to closure, working with cross-functional teams internally and externally.- Provided advice on validation requirements and reviewed validation documentation for implementation of new IT systems.- Performed QC on all medical writing documents generated for clients such as clinical trial protocols and investigator brochures, as well as clinical study reports. - Programmed & maintained a time-sheets app to replace an Excel macro-based solution.

Sydney, Australia

Key Achievements:- First in Asia Pacific to achieve ISO13485:2016 certification.- Improved ANZ training compliance from 85% to 99% across 350+ employees.- Drove CAPA closure by closing 10 CAPAs aged <274 days in 2018, resulting in only 7 open ANZ CAPAs by end 2018- Reassessed engineer radiation & immunization requirements across ANZ.Responsibilities & Milestones:- Covered and improved ANZ recalls handling for 6 months.- Solely managed and revamped ANZ complaint process, and integrated a new customer service survey process introduced in 2017 globally.- Automated & improved training compliance reporting to all line managers.- Solely managed ANZ non-product validation: systems identification and risk assessments. - Worked with HR to improve WHS processes and revamped WHS training.

Sydney, Australia

Key Achievements:- Reduced open & pending complaints in ANZ to lowest level in 12 months.- Improved Asia Pacific RA & QA collaboration by setting up a SharePoint site for document sharing and storage.- Covered for both the Regional Quality Compliance Manager and Quality Engineer in China from end 2015 to early 2016.Responsibilities & Milestones:- Managed the complaints process, and greatly improved communication between manufacturing site investigators and customer-facing sales personnel.- Coordinated & consolidated monthly reports across all Asia Pacific RA & QA personnel.- China: Handled labelling requirements, and continued leading the MD GDP compliance project. - Capitalized on language abilities to develop rapport with the regional HQ in China as well as the manufacturing plant and distribution centre in Malaysia.

Sydney, Australia

Key Achievements:- Led the Quality department during the absence of the Quality Manager.- Championed QMS Harmonization between Alcon & Novartis. Results:* Successful implementation of all Novartis Quality Modules (QM) within 6 months in 2012.* Persistently the #1 leader in the Asia & Russia region for implementation.- Managed ISO13485, ISO9001, and internal audits, resulting in 0 audit findings in the 2014 and 2015 ISO9001 audits.- Revamped the training system by implementing an online solution, reducing overdue trainings to <10%.Responsibilities & Milestones:- Drove CAPA completions, improved RCA efforts, & implemented effectiveness checks. Results: * Reduced maximum CAPA age from 3 years to 1 year.* Reduced open CAPAs by 50% from 2013 to 2014.- Certified Lead Auditor for ISO13485 in internal and supplier audits.- Developed a supplier management system, including risk assessments, audits, and scorecards.- Managed the quarterly management reviews with the leadership team.- Sole document controller for local documents, managing 400+ local SOPs & forms. - Established & implemented processes for validation, risk control, and change control.- Key driver in several IT platform migrations, including documentation control, training, & CAPA.

Singapore

Key Achievements:- Achieved ISO13495 certification within 6 months of new product transfer.- Reduced NCM issues by 80% year-on-year.- Developed automated KPI reporting for all local quality systems.Responsibilities & Milestones:- Performed batch record review & label review before release for shipment. - Internal & Supplier Auditor trained in ISO9001, ISO13485, ISO14001 & OHSAS18001. - Managed process and equipment validation (IQ, OQ & PQ) to achieve ISO13485 certification.- Transferred quality support for ISO13485 and FDA-cleared production lines from US to SG. - Managed the metrology program & calibration tracking software system.

Singapore

Key Achievements:- Led production of 4 separate product lines.- Engaged in NPI for 3 products, including performing Design Verification Tests, manufacturing pilot builds, and completing safety testing for CE certification.- Developed a web-based database for production data logging & tracking.Responsibilities & Milestones:- Led production of 4 separate product lines, which included:* Production planning & manpower allocation* Inventory purchasing, storage, and shipping* Development of SOPs & work instructions- Drove process improvement with established methodologies such as FMEA and 8D.- Worked seamlessly with suppliers to improve supplier deliverables.

- Successfully developed a novel drug discovery tool to quantify deposited collagen matrix in vitro, using immunocytochemistry and microplate reader technology. Publication: Zhibo, W., Nyang, T. K., & Michael, R. (2009, January). Quantitative Immunocytochemistry (QICC)-Based Approach for Antifibrotic Drug Testing in vitro. In 13th International Conference on Biomedical Engineering (pp. 1473-1475). Springer Berlin Heidelberg.

Sindelfingen, Germany

- Successfully implemented a new data recording & analysis system for several assembly line sections.- Took responsibility for tracking & correcting faults for 14 new E- & CLS-class vehicles destined for public exhibition.- Assisted in the trial run of a new fibreglass vehicle sections through the paintwork assembly line, and successfully pinpointed and minimized problematic areas.

Bachelor Of Engineering (Hons), Bioengineering

Activities and Societies: AIESEC: Vice President of Information Systems, Business Incubation of Global Organizations (BINGO): President.

Education record

Gce "A" Levels