Senior Manager / Associate Director, Quality Assurance, Korea

Gilead Sciences

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

Job Description

Specific Responsibilities:

With the commitment and drive you bring to the Pharmaceutical Development & Manufacturing (PDM) workplace, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. You will see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through on-going development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining PDM at Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.

Project Involvement

  • Leads or serves as a key project team member on cross-functional projects, often with higher visibility to senior management within the organization.
  • Provides guidance proactively to the other functions’ members.

Key Differentiating Contributions

  • Leads the QA Function
  • Works closely with other members of the Korean team including RA, Logistics, Safety, Medical and Legal Departments as well as local contract laboratory and distributors.
  • Independently initiates and develops new methods to facilitate management’s ability to make strategic decisions.
  • Develops a strong relationship with executive management, peers and local sales, Overseas affiliates, QA organization and Gilead manufacturing sites
  • Actively participating in meetings where key strategic decisions are made impacting the Korean business.

Essential Functions:

  • Responsible for expanding and maintaining the company’s Compliance/Quality Assurance program.
  • Ensure that Gilead Korea fulfills all requirements linked to local product licenses from QA perspective.
  • Provides guidance to assigned departments and management when specific compliance issues arise.
  • Support new product registration/launch and variation with regard to local QC test and manufacturing site registration (API and Drug product site).
    • Support CMC RA and PDM for the review and approval of local QC specification and test methods and GMP on-site inspection.  Interfaces with Korean Regulatory agencies for relevant issues or questions.
    • Liaise method transfer with local QC laboratory.
    • Performs local comparative dissolution testing data review for variation and provides guidance for local laboratory to complete the testing successfully.  Interfaces with Korean Regulatory agencies and PDM for issues or questions.
    • Support the logistics for import of reference standards and drug product samples for local testing as required.
  • Primarily interfaces with Korean Regulatory agencies  when any quality related case is reported.
  • Ensures maintenance of records required to comply with regulations or administer the Compliance department.
    • Keep KGIP(Korea Good Import Practice) documents including the product master file, product control records and warehouse operation records, etc.
  • Establishes excellent working relationships with compliance/quality groups of vendors or business partners.
    • Deliver the right GxP training in a timely manner and ensure that planned training are implemented and personnel qualifications are suitable for the respective operation.
    • Lead Change Management, Deviation/Discrepancy Management, Risk Management and Validation & Qualification.
    • Provide 3rd party quality oversight and audits of contractors and service providers that have a direct impact on product quality (e.g. 3rd party logistics, warehouses, and testing laboratories).
  • Responsible for maintaining quality of Gilead supplied products to partner companies at a relevant level.
  • Responsible for providing guidance on interpretation and application of existing and new requirements.
  • Responsible for maintaining current knowledge of applicable compliance/quality assurance requirements through attendance at industry and regulatory agency sponsored meetings and seminars.
  • Responsible for evaluating the needs for standard operating procedures and systems to comply with regulatory agencies.
  • Ensure compliance with local law and regulation and consistency with global procedural documents
    • Perform Annual Product Quality Review to evaluate the product quality and quality system.
  • Ensures compliance with the Relevant Laws and Regulations that Relate to the Core Activities of Regulatory Affairs in Gilead.
  • Lead the creation, maintenance, training, evaluation and tracking of all local regulatory owned procedural documents including policies, SOPs, manuals, and working instructions that are needed locally to fulfill regulatory obligations including but not limited to those in scope of GMP/GDP, GPvP (GVP/GPSP), GQP, GLP and GCP.
  • Ensure compliant labeling for Gilead medicinal products in Korea (prescribing information, packaging) and manage timely update.
    • Collaborate RA’s artwork review.
    • Track implementation without any regulatory incompliance
  • May direct others in accomplishing company and departmental objectives.
  • Handling of product complaints process including report to GSIUC, collection and shipment of samples, follow-up of investigation result, communication with distributors and customer management.
  • Request local testing and coordinate with the contract laboratory.
  • Review the batch record (incoming inspection, aggregation, packaging materials) and OC testing record for product market release.

Knowledge, Experience & Skills:

Essential:

  • Excellent Korean and English bilingual communication skills
  • Experience in working with Korean regulatory agencies
  • Good knowledge of local regulations on KGMP/KGSP/KGIP/Quality
  • Demonstrates a highly developed knowledge of compliance/quality requirements and understanding of current global and regional trends in compliance.
  • Is capable of assessing and communicating the impact of these requirements to the business.
  • Demonstrates excellent communication, influencing and negotiation skills.
  • Is capable of leading one or more teams in development of systems and procedures.
  • Is well recognized as an expert resource for compliance advice in other departments.

Typical Education & Experience

  • 15+ years of relevant experience in the pharmaceutical industry and a BS  
  • Deep knowledge and experience in quality assurance in a highly regulated manufacturing environment.
  • Moderate knowledge and experience in analytical, process chemistry and/or formulation development
  • QA Manager and/or Quality Control Laboratory experience preferred

If this is not the right move for you now but remain interested in a career at Gilead Sciences please connect with us via our talent community: https://gilead.avature.net/Gilead


For jobs in the United States:

As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact careers@gilead.com for assistance.

For more information about equal employment opportunity protections, please view the ‘EEO is the Law’ poster.

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For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

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