JUN HAO (JUN) TAN

ad2n6k@r.postjobfree.com • 919-***-**** • www.linkedin.com/in/jun-hao-tan-93905050

CORE COMPETENCIES

Seasoned Quality Professional with ten plus years of experience in pharmaceutical industry Working knowledge of QMS and GMP requirements Experience working with biopharmaceuticals and supply chains Additional experience as a licensed pharmacist Experience working at an electronic consumer products company Strong knowledge of 21 CFR 210/211, Part 11, Part 820, Part 110, Part 111, ICH Q7, ICH Q9, ISO 9001:2015, ISO 9000, PIC/S GMP Part 1, IPEC Excipient GMP

EXPERIENCE

SQA Services

Senior Quality Auditor

• Performed as needed on-site/remote supplier quality audits for various suppliers within the life sciences industry

• Conducted an initial supplier qualification of an aseptic manufacturing plant for an international pharmaceutical company in accordance to 21 CFR Part 210/211

• Collaborated on a joint audit of a contract manufacturer of APIs in accordance to ISO 9001:2015 and 21 CFR Part 210/211

• Led the audit of an excipient manufacturer according to ICH Q7 standards Durham, NC

2023- Present

Open Book Extracts

Quality Executive

• Ensured manufacturing areas are compliant with current guidance, industry standards and cGMP requirements and documentation has been completed to the 100% per Good Documentation Practices

• Participated in internal and external/ regulatory audits as required, reducing possible quality risks by 100%

• Reviewed all batch records, released all raw materials, signing off as final quality signatory while ensuring standardized testing on products, achieving 100% compliance Durham, NC

2021- 2021

IQVIA

Senior Consultant, Global Compliance Consulting

• Valuation of current processes, and recommendations of program enhancements to compliance analytics like Fair Market Value, Transparency data analytics and managed the policies and SOPs, methodologies, rate cards and tiering of

• Conducted auditing and monitoring in terms of plan development, live monitoring, transactional reviews and outsourced managed monitoring services

• Created high quality deliverables such as slide decks, process maps, charts, graphs and data visualizations that incorporate objectives, issues, insights, findings and recommendations

• Conducted interviews, working sessions, workshops, status updates, kickoff meetings with key stakeholders, SMEs

• Managed project management documentation, project objectives, project plans, identification of project tasks, analysis and synthesis of primary/ secondary research, trends, anomalies and outliers into executable strategies

NYC, NY

2019 – 2020

PricewaterhouseCoopers (PwC)

Senior Associate, Intern, Pharmaceutical and Life Science Operations practice

• Active participant in quality/ regulatory project management associated with first time launch of a medical device by an electronic consumer products company

• Conducted interviews with stakeholders to understand internal processes and to propose relevant FDA compliant solutions

• Strategize market access insights for the novel medical device by interpreting market access information for future strategic initiatives and business decisions Boston, MA

2018 – 2018

GlaxoSmithKline (GSK)

Supply Chain Quality Assurance Executive, Quality Assurance

• Pioneered project to merge supply chains within emerging markets of Cambodia, Laos, and Myanmar; maximized cost efficiencies and improve supplier relationship despite ambiguity in local practices

• Exceptional problem solving skills in leading an organizational continuous improvement process for supply chain quality management; outlined program objectives and KPIs

• Managed and collaborated with third party quality team (team of 5 personnel) in forecasting, warehousing, relabeling and distribution of medically critical pharmaceutical products thus preventing recall of products worth up to 1.8 million USD Singapore

2016 – 2017

YOURWAY TRANSPORT BIOPHARMA

A global clinical trial materials company, Manager, Clinical Supply Chain Management and Quality Assurance

• Owner and administrator of supplier management system, approved supplier list (ASL) and supplier corrective action requests

• Performed initial and regular risk based audits for the qualification and maintenance of external vendors on ASL

• Collaborated with external vendors and internal departments to investigate and resolve quality issues like deviations, failures, complaints, and temperature excursions to prevent their reoccurrence

• Spearheaded all OOS investigations, deviations, change controls and CAPAs

• Presented quality metrics and any significant quality issues to senior management during regular quality councils

Singapore

2013 – 2016

MERCK & CO

Consultant, Medical Affairs

• Hired as an independent consultant to create a new training program for pharmaceuticals sales representatives for several pipeline assets

• Partnered closely with marketing, medical affairs, and commercial operations teams to develop and test salesforce training materials as per FDA regulation

• Collaborated closely with Medical Science Liaisons on the management of Key Opinion Leaders (KOLs) via the internal KOL Management System Singapore

2013

WATSONS PERSONAL HEALTHCARE

Pharmacist

Singapore

2010 – 2012

EDUCATION

DUKE UNIVERSITY, The Fuqua School of Business

Master of Business Administration, Certificate in Health Sector Management Durham, NC

May 2019

NATIONAL UNIVERSITY OF SINGAPORE

Bachelor of Science Degree, Pharmacy

Singapore

June 2010

ADDITIONAL INFORMATION

PERMANENT US WORK AUTHORIZATION

Volunteer, Singapore Committee for United Nations Women, “Project Inspire” an initiative for social entrepreneurs to pitch funding for ideas to better women’s welfare in Asia and the Pacific. Bilingual in English and Mandarin. Interests: running, Game of Thrones, cooking.

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