The Director, Global Product Quality provides guidance and expertise to OAPI/OPDC in the interpretation and implementation of manufacturing and quality system regulations applicable to commercial drug products, medical devices and combination products. Ensures that SOPs describing internal processes are developed and maintained and that the appropriate quality audits are conducted and responded to in order to maintain compliance with GMP regulations and guidelines.
Host FDA for on-site GxP inspections
Provide global expertise for data integrity across GxP functions
Designs and implements institutional quality management systems and quality programs to ensure sustained GMP/QSR compliance.
Compliance with QSR 820 and Part 4
Compliance with 210 and 211
Otsuka Policies and Procedures
Manages the oversight of vendors and contractors, including qualification and contract management.
Deals with disposition (release/rejection) of components, as well as investigational and commercial finished medical device and drug products.
Manages the batch record review and release process Quality Management Activities of Commercial Product (API, drug product, and final finished product).
Review the Batch records for API, Bulk, Commercial finished products (drug products or medical devices) and release the product for further processing or commercial distribution as applicable.
Coordinate and work with Suppliers, Digital Medicine, Technical Operations, and Medical Device Division and regulatory Affairs to establish Design Controls (Design History file and Device Master Record, etc.) and oversee Risk Management Activities for Medical Devices, Combination Products and software applications (Mobile Apps, Web Applications etc.).
Collaborate with Technical Operations, Medical Device Division and Regulatory Affairs for any changes/development to Design/Design History File/Device Master record for medical devices and/or combination products and software applications (Mobile Apps, Web Applications etc.).
Ensures Quality Agreements are executed with third-party vendors; oversee compliance with Quality Agreements.
Develops, implements, and maintains policies, systems and procedures describing internal processes for management of quality and compliance with applicable regulations and guidelines.
Quality Collaboration with CMOs for the review of process changes and improvements, investigations and root cause analysis of process deviations, corrections, corrective actions, out of trends, and OOS as applicable.
Provide oversight and ensure that Change controls, deviations/investigations, CAPAs are initiated and executed as applicable in a timely manner.
Liaises with Senior Director, Auditing and Monitoring, to plan and manage the conduct of periodic internal audits to assure that departments are meeting regulatory requirements and complying with quality management system requirements.
Liaises with Senior Director, Auditing and Monitoring to ensure the timely execution of audit plans to assess and maintain compliance with global manufacturing and quality system regulations for pharmaceuticals and medical devices.
Manages and Host GMP Inspections and assures the preparation for, management of and response to regulatory inspections as applicable in collaboration with OAPI.
Provides leadership in the coordination and management of any corrections, removals or recalls or field alerts with other quality related crisis.
Presents to Senior Director/Senior Management, GMP/QSR performance metrics update, trend overview, and other strategic analyses related to GMPs and QSRs
Ensures all required GMP/QSR training requirements are satisfied for the department.
Proactively manages a staff FTEs and independent contractors to ensure the department is operating effectively, efficiently, and within budget.
Conduct internal audits and supplier audits to ensure compliance with Otsuka requirements as well as applicable regulatory requirements
Bachelor's degree in Engineering or other Physical Sciences or + 10 years of combined and/or pharmaceutical/Medical devices manufacturing, QA or QC assurance roles
6-8 years of Quality Management experience in the medical device and/or pharmaceutical manufacturing
Expertise in FDA 21 CFR Parts 820, 211 and 210 quality system requirements
Expertise in Data Integrity requirements
Ability to manage and prioritize multiple tasks
Experience in using MS Word, Excel, and Access
Excellent interpersonal and communication skills
Lead Auditor/Internal Auditor Certificate for ISO 13485 quality management system
Experience with TrackWise System for handling deviations, change controls, complaints, investigations
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.
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At Otsuka, our people are passionate about developing and delivering original products as part of a global holistic commitment to better health and well-being. We have two core businesses dedicated to achieving our goals: a pharmaceutical business and a nutraceutical business. The pharmaceutical business develops and markets products for the diagnosis and treatment of disease in the following areas: central nervous system, oncology, gastroenterology, ophthalmology and cardiovascular. The nutraceutical business is dedicated to maintaining and improving health through the use of foods and beverages that provide extra health benefits in addition to their basic nutritional value. Since the beginning, nearly 100 years ago, the Otsuka family sought to develop products that stood out from the crowd, by traveling down the paths of discovery where others were less likely to tread.
We believe our culture and our people are the differentiators that empower us to produce breakthrough results. This is what makes us a big venture company that takes risks and focuses on unmet medical needs in order to develop new and better therapeutic compounds. We harness the extraordinary cr...eative and innovative abilities of our people to solve problems differently, and to persevere until they find answers. We are in this for the long-haul. Otsuka is a highly ethical company. We adhere to the highest standards in how we develop and deliver our products, and in how we treat our most valuable assets: Otsuka-people. We encourage them to follow their dreams, as turning dreams into reality is at the core of everything we do. It paves the way ahead to achieve our shared purpose: impacting on human health to help people live better lives.