[Innovative Medicine] Senior Quality Specialist

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Quality

Job Sub Function:

Customer/Commercial Quality

Job Category:

Professional

All Job Posting Locations:

Seoul, Korea, Republic of

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

Position Summary
Established and productive individual contributor, who works under moderate supervision. Supports the execution of tasks related to fulfilling the quality and regulatory requirements and established standards and customer needs for the organization's products, processes, and services. Implements strategy and vision of continuous improvement and feedback through assessments and reporting. Develops close partnership with all marketing companies functions and external business partner to identify risks and improvement opportunities and enhance the customer experience.

Essential Job Duties and Responsibilities

[Quality Systems]

• Ensure appropriate change control procedures are followed. Monitor change control status for timely closure and support issues related to COMET.
• Ensure appropriate quality event management procedures are followed. Monitor QEM status for timely closure and support issues related to COMET.
• Prepare quality metric data for QSMR and monthly review for change control and purchasing control. Keep related trackers up to date.
• Update and keep product list up to date on TruVault.
• Establish and revise LOC procedures in accordance with local GxP, CQM and J&J requirements for change control.
• Support internal audit and HA inspection for auditing and documentation  Support supplier qualification and document management.

[Quality Process]

• Manage the management of QA activities for imported products release from End to End, incoming inspection, sample shipment arrangement, release checklist preparation and so on.
• Ensure the redressing requirement from End to End, visual check against retention sample with approved artwork, confirming redressing artwork and preparing redressing instruction and so on.
• Oversee the new product introduction process including test method transfer, QC tests, change control management and master formula preparation.
• Establish Annual Product Quality Review in a timely manner.
• Ensure warehouse 3PL oversight and self inspection by periodic walk-through.
• Conduct supplier and distributor management.

[Minimum Qualification]

• At least 2 years’ experience in the Pharmaceutical or related industry, ideally with a mix of Manufacturing / QA operations.
• Bachelor’s degree in Pharmacy / Chemistry / Life Science / Microbiology or equivalent.
• Demonstrated experience in internal and external audits, regulatory inspections, Product Quality Complaint (PQC) handling, Nonconformance and Change Control management, document control, training management, batch release activities, and new product launch preparation.
• Strong organizational and time management skills, with the ability to effectively manage multiple priorities in a dynamic environment.
• Highly detail-oriented with a strong commitment to quality, accuracy, and timely execution of assigned responsibilities.
• Proactive and adaptable mindset, with the ability to effectively navigate change, assess risks, and respond to unexpected challenges.
• Strong interpersonal and collaboration skills, with a demonstrated ability to work effectively in cross-functional and multicultural teams.
• Understanding of pharmaceutical product development, qualification, manufacturing, packaging, validation, testing, release and distribution processes.
• Up-to-date knowledge of relevant pharmaceutical legislation and GxP including but not limited to GMP/GDP.
• Korea and English bilingual is preferable. At least, fluent English in both verbal and written.

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Legal Entity

Innovative Medicine

Job Type

Fixed Term (1 year)

Application Documents

Free-form resume AND cover letter is required (in Korean or English).

Application Deadline

Open until the position is filled.

Notes

• Preference will be given to individuals subject to national veterans’ benefits and persons with disabilities upon submission of relevant documents as per applicable laws.
• Only candidates who pass the resume screening will be notified individually. However, notifications may be delayed due to company circumstances.
• If any false information is found in the application documents, the hiring may be canceled even after the offer is confirmed, and future applications may be restricted.
• Submitted documents will not be returned and will be deleted upon request.

 

 

Required Skills:

 

 

Preferred Skills:

Audit Management, Business Behavior, Coaching, Compliance Management, Continuous Improvement, Data Analysis, Detail-Oriented, Goal Attainment, Internal Controls, Issue Escalation, Problem Solving, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment