Senior Specialist, GDP&PQC

Posted:
10/14/2024, 9:14:43 PM

Location(s):
Chiyoda, Japan

Experience Level(s):
Senior

Field(s):
Operations & Logistics

Workplace Type:
Hybrid

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.

Key Responsibilities and Major Duties :

  • Contribute to maintaining a stable supply of high-quality BMSSKK products to the market as quality experts.
  • Contribute to GQP and GDP performance by following Pharmaceutical and Medical Devices Law and GDP Guidelines and cooperating with internal/external stakeholders.
  • Appropriately analyze the quality information received and minimize the risk derived from quality issues.
  • Arrange quality agreements between strategic alliance partners.
  • Analyze and evaluate product quality and propose and enforce quality improvement counterplan.
  • Enforce preventive measures for deviation reoccurrence.
  • Investigate the cause of the complaint about BMSKK product quality and prepare a response letter. If necessary, visit customers and explain the report.
  • Monitor the trend regarding quality complaints and issues, communicating and confirming the trend with BMSKK Aichi Plant and another manufacturing site.
  • To fulfill customer satisfaction, support the quality issue to the solution by analyzing it and discussing it with BMSKK Aichi, Marketing, Medical Information, and other related departments.
  • Plan and execute the CAPAs for quality improvements by analyzing the information related to product quality complaints.
  • Identify and minimize any risk in market distribution through the risk management process.
  • Work closely with BMSKK Aichi Plant, Supply Chain Management, and Wholesaler Strategy group to fulfill the GDP duties.
  • Assure product quality and product safety during distribution comply with GDP guidelines.
  • Management of the Distribution Center and the manufacturer affiliated with the Distribution Center.
  • Evaluate and examine quality information, such as temperature deviation, package damage, and other incidents during storage/transportation.
  • Support GDP Supervisor/Manager for change control, CAPA, PQC, deviation, computerized systems, and audits to improve the GDP quality system and product quality.

Supervisory Responsibility:

  • N/A

Travel Requirements:

  • Domestic and occasional international travel are required.
  • Travel to the manufacturing site in a foreign country, 1 -2 weeks each trip, 1-2/year.

List of minimum requirements

Degree/Certification/Licensure

  • A bachelor's degree in a scientific discipline; an advanced scientific degree is preferred.

Required Competencies

  • Knowledge of the quality management system philosophy, including Pharmaceutical Affairs Law, GQP Ministerial Ordinance, GDP Guidelines, ICH, QMS Ministerial Ordinance, ISO13485, and related laws and regulations.
  • Basic knowledge of DS/DP manufacturing, packaging operation, quality control testing and Japanese Pharmacopoeia.
  • Communication skills for achieving good relationships with authorities and connected departments.
  • Capabilities of analyzing the management results of manufacturing sites, make instructions for improvement if necessary.
  • Communication skills in English via email and at meetings with overseas in charge person.

Experience – Responsibility and minimum number of years

  • More than 7 years in the pharmaceutical or medical device industry with Quality and/or Supply Chain and/or Manufacturing experience.

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [email protected]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

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