Quality Manager- Sterile Prod & Medic
The Judge Group Inc.

Location: Morristown, NJ
Salary: TBD
Description: Our client is currently seeking a Quality Manager- Sterile Prod & Medical Device

The Quality manager will be interacting primarily with Company's external business partners/CMOs. The incumbent will have responsibility for complex sterile products and medical devices throughout the entire lifecycle of the product (i.e. from development through discontinuation) and is responsible for supporting the adherence to Company's Quality Management System.

This job will have the following responsibilities:

Documentation Review & Approval:

• Review and approve documentation such as Method Validations, Manufacturing Records, SOPs, Investigations, Change Controls, Validation Reports, Equipment Qualifications and similar documents as directed by Quality Management.

Inspections and Audits:

• Prepare / Support preparation activities for regulatory inspections
• Evaluate regulatory agency findings from inspections conducted at CMOs/CPOs/analytical Laboratories, etc.

Support the design and implementation of system / process improvements where opportunities are identified (Commercial & Development), including associated CAPA's.

Support technical transfer / validation activities with external business partners / CMOs.

Manage the Commercial Finished Product / Bulk Drug Product Release System

Communicate with external business partners / CMOs regarding quality related issues and Quality Agreements.

Provide investigation/trouble-shooting support as needed. Ability to review and approve complex investigations, unexplained discrepancies, failures, and out-of-specification results. Evaluate if there is any quality impact to process/product and take appropriate action.

Track metrics for external business partners / CMOs on change controls, deviations, complaints, audits, product releases and rejections and other Third-Party Quality Key Performance Indicators.

Review Annual Product Reports / Product Quality Reports.

Change Management Program:

• Process change controls for all systems requiring change control support (e.g. specifications for raw materials, drug product intermediates and finished drug products, validation protocols and reports, master production and packaging records, cleaning records, and analytical methods).
• Maintain change control electronic records in EQMS.
• Review, assess, and approve change controls as required by SOP's.
• Support training of company personnel on change control system.

Qualifications & Requirements:

BS in Pharmacy, Chemistry, Microbiology or Biology with a minimum of 10 years' experience in the Pharmaceutical Industry preferred, with a minimum of five years in a quality organization. Other degrees will be considered based on extensive industry experience.

Experience in GxP laboratory practices, ability to review and assess data.

Release of materials and products supporting both development and commercial activities.

Has knowledge of GxP quality systems, US FDA regulations and ICH guidance documents.

Experience with various complex manufacturing / filling processes associated with 'sterile' drug products and medical devices.

Experience in trouble-shooting and conducting investigations.

Strong technical writing and computer skills also required.

Contact: arawat@judge.com

This job and many more are available through The Judge Group. Find us on the web at www.judge.com

This job has expired.