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Otsuka Pharmaceutical
United States
1 day ago

Description

Position Summary

The Director, Global Quality Management, IMP/GMP R&D Operations leads the development, implementation and maintenance of the GMP quality systems and tools required to manage and monitor the quality and compliance of GMP Suppliers utilized in the clinical manufacturing, packaging, labeling, distribution, and testing of OPDC research and development products. The position also works collaboratively with other functional department leads within OAPI/OPDC and with Quality counterparts across Otsuka Companies, Affiliates and Subsidiaries to assure Compliance with local and global procedures and regulatory requirements, and drive harmonization and continuous improvement.

Key Job Responsibilities
  • Establishes and maintains the effectiveness of Quality Systems for managing GMP activities supporting research and development (R&D) projects.
  • Oversees development and maintenance of Standard Operating Procedures, work instructions, forms, templates, and other documents associated with the systems noted above.
  • Responsible for overall Quality and compliance of GMP suppliers providing contract manufacturing, clinical packaging and labeling, distribution, and testing services for OPDC R&D projects.
  • Leads and provides subject matter expert support for internal and Supplier GMP audits that support R&D projects to ensure compliance with OAPI and OPDC requirements as well as applicable regulatory requirements.
  • Establishes and oversees the management of clinical product quality complaints to ensure U.S. clinical product quality complaints are documented, coordinated, investigated, resolved, and closed out in a uniform, compliant and timely manner. Ensure PQCs are trended to ensure early detection of potential quality issues.
  • Leads resolution of critical quality issues. Escalates quality issues to senior management when appropriate.
  • Directs team in the batch record review and disposition of Investigational Medicinal Products (IMP).
  • Business Area owner of the OPDC Quality R&D Division Trackwise Modules. Leads design/configuration of the TW Modules, recommends enhancements, approves user access requests, supports validation and training.
  • Quality Lead on cross-functional CMC Project Teams for key R&D projects
  • Quality Lead on Due-Diligence Teams that identify potential GMP suppliers.
  • Partners with Senior Leadership on global and department wide initiative to meet business goals.
  • Develops and actively manages cost center budget.
  • Develops and maintains cost center training curriculum.
  • Ensures Quality Agreements are executed with R&D vendors and that Quality agreements remain in compliance with local and global procedures. Approves Quality Agreements.
  • Develops and maintains quality metrics to monitor GMP supplier performance.
  • Interfaces with R&D Vendors, Tech Ops, Technical Services and Clinical Supply Chain Sourcing to drive Compliance and Quality improvements that minimize the Costs of Quality, specifically component, materials or finished product deviations. OOS incidents, rejects, etc. while maintaining the global supply chain and clinical study timelines.
  • Collaborates with project teams supporting Key R&D projects to assure that goals set by the team as they relate to potential suppliers are consistent with local and global quality objectives and relevant governmental requirements.
  • Perform quality review of CMC sections for regulatory submissions.
  • Back Room Lead for OPDC FDA Inspections.
  • Leads coordination and management of clinical stock recoveries/recalls.
  • Ensure staff has clearly defined goals and objectives, and provide coaching, training, and development opportunities to them to enhance staff knowledge and sustain employee engagement.


Knowledge, Skills, Competencies, Education, and Experience

Required:
  • Bachelor's degree in Chemistry, Engineering, or other Physical Sciences
  • 10 years of combined experience in pharmaceutical manufacturing role, and/or QA role supporting GMP activities for Investigational Medicinal Products or Commercial Products.
  • 6-8 years of Quality Management experience in pharmaceutical manufacturing.
  • Thorough understanding of the Drug Development process and regulatory requirements.
  • Ability to handle interactions and resolve issues with internal customers and GMP Suppliers in a tactful, professional and effective manner.
  • Ability to manage and prioritize multiple tasks
  • Proficient using Microsoft Office software, Trackwise
  • Excellent interpersonal and communication skills
  • Strong analytical problem solving and decision-making skills.
  • Risk Management experience.
  • Ability to work in a team environment.
  • Position requires approximately 30% domestic travel; Occasional international travel may also be expected.


Preferred:

• 5 years of experience in GMP Supplier/internal auditing

• Experience with medical devices/combination products

• Experience in Clinical Packaging/Clinical Supplies Operations

Educational Qualifications

Required:

• Bachelor's degree in Chemistry, Engineering, or other Physical Sciences

Preferred:

• ASQ certification or equivalent

List Level: Management Level (Director)

Come discover more about Otsuka and our benefit offerings;https://www.otsuka-us.com/careers-join-otsuka.

Disclaimer:This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.

Statement Regarding Job Recruiting Fraud Scams

Job postings, job offers, or introductions to enter into a business relationship with Otsuka through a third-party vendor may be unauthorized. Avoid being the subject of a scam by dealing only directly with Otsuka through its official Otsuka Career website https://vhr-otsuka.wd1.myworkdayjobs.com/en-US/External . Any authorized third-party vendor job boards should redirect any inquiry to this Otsuka Career website.

Job Information

  • Job ID: 59789468
  • Location:
    United States
  • Company Name: Otsuka Pharmaceutical
  • Position Title: Dir Global Product Quality R&D Operations
  • Job Type: Full-Time
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