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
* Designs and implements institutional quality management
systems and quality programs to ensure sustained GMP/QSR
* 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
* 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
* 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
* 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
* 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
* Conduct internal audits and supplier audits to ensure
compliance with Otsuka requirements as well as applicable
* 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
* 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
Salary : Negotiable
Position SummaryDirector serves as a key driver for
high-priority complex programs and provides prog...
Senior Director E&C Healthcare Law Monitoring and Auditing
develops and oversees the comprehensi...
Scientist, Product Development Valencia, CA HELP US BRING THE
GIFT OF HEALTH TO LIFE. Working at Ph...
ISPOR is searching for a talented marketing professional to join
the team in the Princeton, NJ area....
At Otsuka and on our team, we believe creativity is everything.
Without innovation, there is no real...
The HBA's purpose is to further the advancement and impact of
women in the business of healthcare
US office :
373 Route 46 West Bldg E, Suite 215 Fairfield, NJ 07004
Phone: +1 (973) 575-0606 Fax: +1 (703)-852-4414 Email: