Regulatory and Quality Lead – Korea

Type:

Permanent

Categories:

Quality & Validation

Species:

Poultry, Swine

Region:

APAC

Country:

Korea; Republic Of (South)

City:

Seoul

Job ID:

VRN1006

#LI-AK1

Regulatory & Quality Assurance Lead – Korea
 

An exciting opportunity is opened for Korean based RA/QA leaders in the pharmaceutical industry. Our client, a global leader in the Animal Pharmaceutical Health Industry is looking for a top notch Regulatory & QA Senior Leader to join their team in Seoul Korea. The role would give the successful candidate an opportunity to lead the process of ensuring regulatory compliance and quality of our client’s product portfolio in Korea.

Successful candidates will have key responsibilities of:

The RA portion will involve:

  • Collaboration with all stakeholders in the organisation to develop and implement robust regulatory strategies and portfolio prioritization for Korea and ensuring successful execution
  • Communicating changes in local regulatory requirements throughout the company
  • Building strong relationships with all relevant regulatory and government authorities to ensure effective iterations leading to timely approval of products
  • Communicating openly with all stakeholders to answer inquiries, and provide feedback related to or impacting regulatory approvals
  • Lead or provide guidance to Korea/global cross functional teams to prepare all documentation required for product registrations or claim extensions and maintaining databases for the worldwide regulatory status of products
  • Staying up to date with local regulatory regulations
  • Assisting with regulatory audits from partners and external regulatory affairs agencies
  • Manage updates to local regulatory documents pertaining to manufacturing site, label or specifications changes (name, style, contents, etc.) driven by globally or locally required changes

The QA portion will involve:

  • Quality System Implementation and Management
  • Leads the deployment of applicable Product Quality Systems within the country office
  • Work closely with warehouse management to ensure that Quality systems implemented properly
  • Ensures staff receives required training on local Quality Systems/Processes and prepares all the support documents for the training: forms, presentations, evaluation sheets
  • Ensures implementation of all applicable Product Quality SOPs. Create, review, approve, maintain adequate procedures and controlled documents
  • Monitors local quality and compliance environment to ensure regulatory expectations concerning product quality are met by adjusting/enhancing local systems and processes when required and informing country and above country stakeholders of changes/new requirements
  • Conducts internal assessments to assess compliance with quality systems
  • Maintains alignment between corporate quality systems and local requirements
  • Resolution of Product Quality and Compliance Related Issues
  • Focal point of contact for GMS, COQA, GQO for all Product Quality, Pharmacovigilance and Compliance Related Issues that arise in Korea (coordinating with Global Affiliate Leader, supported by Regional Quality Leader)
  • Deviation Management: leads/ supports/ implements and follows up agreed action to address product quality/compliance issues identified when product is in the market place. Executes recalls and stop distributions.
  • Support Inspections and Internal Audits
  • Leads (participates) local Agencies Inspections in the Affiliate on Product Quality & GMP/GDP aspects.
  • Participates but not lead other organisational Internal Audits made by GMS audit group on Product & GMP/GDP aspects
  • Development and Maintenance of Consistent Quality Culture
  • Metrics quality performance and communicates to Korea LT and Global/Regional Quality Lead
  • Provides ongoing education on Quality to relevant local Korea functional groups
  • Routine in Country Quality Activities
  • QA Batch release: Release of product for the Local Market consistent with local regulations
  • Assure temperature readings/filing from Dataloggers and excursions investigations
  • Quality oversight of the Logistics Service Provider Warehouses, i.e. the validation of warehouse and cold store, shipping system qualification, repacking/relabelling operations, returns, Good Distribution Practice (GDP) standards implementation
  • Assists Global Security with investigations on issues of theft, diversion, and counterfeiting

Requirements:

  • University Degree in pharmacy or biological sciences
  • 10 years of min. experience in similar roles in Animal Health or Pharmaceuticals, with at least 3 in people management role
  • Excellent command of both written and spoken English
  • Computer proficiency in Microsoft Office Set
  • Can-do/positive attitude and negotiation skills
  • Ability to adapt to a fast pace environment and performance culture

If you are looking to take the next step in your QA/RA career, apply online referencing VRN1006 ensuring you include a cover letter outlining your suitability for the role.

For a discussion with us about how you fit this position, please contact Alicia Keenan via email: akeenan@aicila.com

 

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