Manager Supplier Quality

US-NJ-Princeton | US-NJ-Princeton
Requisition ID  2019-10602

Responsibilities

The supplier quality manager will monitor the External and Internal Audit Program for timely completion of required activities, and perform audits of third party manufacturers and suppliers, to ensure compliance with GMP regulations, contracted business agreements, and company policies.

 

Applicable GMP regulations, will be all regulations required for manufacturing and distribution of drug products, medical devices, drug/device combination products, and clinical supplies for investigational use.

 

The incumbent will collaborate with other departments, in addition to global affiliates and subsidiaries, to establish and maintain the effectiveness of the GMP External/Internal Audit programs.

 

The position requires up to 50% travel; mostly domestic and occasional international travel may be required.

 

  • Support Global Product Quality lead to ensure that all required internal and external audits are planned and scheduled.
  • Leads and conducts audits of contractors and suppliers to ensure compliance with Global and Local Otsuka, and applicable regulatory requirements.
  • Ensure that audit documentation is accurate, complete, and issued within the required timeframe.
  • Review and approve CAPA plans for audit observations.
  • Interfaces with Contractors, Suppliers, Tech Operations, Technical Services and Supply Chain, and Clinical Supply Operations to drive Quality improvements that minimize the Costs of Quality, specifically for component, materials or finished product suppliers
  • Compiles and reports key performance indicators, metrics and compliance status of Internal Audits and GMP Outsourced Activities to Senior Management. Author Standard Operating Procedures, work instructions, forms, templates and other documents associated with the audit process as needed and for periodic review.
  • Works collaboratively within Global Product Quality and other functions across Otsuka Affiliates and Subsidiaries to ensure compliance to internal standards and regulatory requirements.
  • Assists in the development of training programs for inspection readiness and improvements with Internal Audit and Supplier Quality Programs along with other Quality Systems.
  • Participates in Inspection Readiness activities and supports Regulatory Inspections.
  • Support project teams to ensure that team goals are consistent with global and local quality objectives, in addition to government requirements.

Qualifications

Required:

  • Bachelor’s degree in Biology, Chemistry, Engineering or other Physical Sciences.
  • At least 5 years of experience in highly regulated environment (such as pharmaceutical manufacturing and medical device) QA or QC roles of which 1 or more years of experience in internal/external auditing.
  • Working knowledge of cGMP FDA 21 CFR Parts 820, 211 and 210, and 11 quality system requirements.
  • Ability to handle contractor/supplier audit situations and interactions in a tactful, professional and effective manner
  • Ability to manage and prioritize multiple tasks.
  • Excellent interpersonal and communication skills.
  • Ease with electronic environment/computer skills and Innovation skills.
  • Proficient in MS Office, Visio, and TrackWise.

Preferred:

  • ASQ CQA or equivalent
  • Six Sigma Green Belt.

PMP certified

 

Overview

Otsuka Pharmaceutical Company is a global healthcare company with the corporate philosophy: “Otsuka-people creating new products for better health worldwide.” Otsuka researches, develops, manufactures and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health.
In pharmaceuticals, Otsuka is a leader in the challenging area of mental health and also has research programs on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a “big venture” company at heart, applying a youthful spirit of creativity in everything it does.
Otsuka Pharmaceutical Company is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 45,000 people worldwide and had consolidated sales of approximately USD 11 billion (€ 9.9 billion) in 2016.
All Otsuka stories start by taking the road less travelled. Learn more about Otsuka Pharmaceutical Company on its global website at www.otsuka.co.jp/en. Learn more about Otsuka in the U.S. at www.otsuka-us.com.

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.

To Apply: Go to this link