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Director, Global Product Quality

Company: Healthcare Businesswomen’s Association
Location: Rockville
Posted on: September 12, 2020

Job Description:

Position Summary:

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

Qualifications :

* 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

Preferred :

* Lead Auditor/Internal Auditor Certificate for ISO 13485 quality management system

* Experience with TrackWise System for handling deviations, change controls, complaints, investigations

Salary : Negotiable

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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: info@hbanet.org

Keywords: Healthcare Businesswomen’s Association, Rockville , Director, Global Product Quality, Other , Rockville, Maryland

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