Job Purpose

Lead Korean analytical operations, including analytical method transfers to the 3rd Party Labs and commercial product testing according to local regulatory and GSK requirements in order to support new product introductions and the release of commercial batches.

Job profile

• Manage and provide the vision, strategy and leadership oversight on all analytical responsibilities of GSK products within South Korea.

• Lead a group of 3-4 team members

• Accountable for analytical activities for GSK product launch and commercial testing in South Korea including sample/reagent management, analytical tech transfer and documentation support.

• Oversee the analytical technology transfer of methods and testing strategies from GSK/ CMO donor sites to the 3rd Party contract testing labs in South Korea.

• Oversee the analytical testing of commercial products in South Korea, incl. out of specification results handling and investigations.

• Ensure effective management of quality incidents associated with analytical activities impacting Korean market.

• Maintain open communications and quick escalation with the donor sites; provide insights and issues related to the analytical, QC, sample/reagents request and supply to support product supply in South Korea.

• Maintain open communications and quick escalation with internal and regional stakeholders (in Quality, Commercial, Regulatory).

• Develop quality work processes to support the relevant analytical activities. These may include authoring or reviewing templates, guidelines, SOPs, policies or project plans.

• Review or author protocols, reports and other documentation related to analytical activities in South Korea.

• Work closely within and across functional matrix teams to ensure successful registration and local market release testing.

• Manage contracts, compliance standards and performance review associated with 3rd Party contract testing laboratories.

• Ensure all analytical activities are compliant with the local regulations and GSK Quality Management System.

Key Responsibilities

• Manage local funding and budget.

• Manage a group overseeing the analytical testing, method transfers and the supporting infrastructure for GSK products in South Korea.

• Responsible for developing and executing strategies to address Korean local testing requirements.

• Ensures change management is followed for analytical methods and specifications.

• Ensure the interface between the Local Operating Company (LOC) and GSC/R&D project teams are aligned with the market requirements.

• Ensure Quality and Corporate Compliance are maintained with the analytical activities.

Job-Related Skills/Background

• Significant knowledge of cGMP and Regulatory requirements for the development and commercialization of pharmaceutical products, biopharmaceuticals and vaccines. Familiar with FDA/EU/ICH and Korean regulations and guidance particularly as they relate to Analytical Testing.

• Solid Quality experience (> 10 years) in pharmaceutical industry, preferably for Biotech/ Biological products

• Extensive knowledge of analytical method development, technical transfer and validation.

• Experience with CoA issuance, OOS handling and investigations.

• Certified & licensed pharmacist with industry experiences is preferred.

• Problem identification and solving skills.

• Ability to enable and drive change.

• Excellent written/verbal communication, presentation and influencing skills.

• Fluent in English; fluent Korean is an advantage.

• Effective project management skills.

• Present at internal and external meetings.

• Leadership skills.

• Competent people manager and able to identify and promote talent:

  - Coach/mentor to achieve full potential
  - Sets goals and assigns tasks
  - Manages performance and develops performance plans
  - Conducts performance appraisals and makes recommendations for advancement and development

*LI-GSK

Why Us?

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.  ​
 
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.​

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.