Quality Relationship Manager

Proclinical, in support of our client, are seeking an individual to fill the role of Quality Relationship Manager, based in New Jersey. The successful candidate will interact primarily with external business partners/CMOs and will take on responsibility for products throughout the entire life cycle. Additionally, the incumbent will support adherence to the Quality Management System.

Responsibilities

• Review and approve documentation as directed by Quality Management.
• Prepare/support preparation activities for regulatory inspections.
• Evaluate relevant regulatory agency findings.
• Support design and implementation of system/process improvements.
• 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 on relevant issues.
• Review and approve investigations, 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.
• Process change controls for all systems requiring change control support.
• Maintain change control electronic records in EQMS.
• Review, assess, and approve change controls as required by SOPs.
• Support training of company personnel on change control system.
• Support the corporate training and audit programs when/if needed.
• Keep abreast of industry regulations, guidelines and cGMP trends

Skills And Qualifications

• BS in Pharmacy, Chemistry, Microbiology or Biology with 10+ years' experience in the Pharmaceutical Industry preferred, and with 5+ years in a quality organization.
• Experience in GxP laboratory practices with the ability to review and assess data.
• Release of materials and products supporting both development and commercial activities.
• Knowledge of GxP quality systems, US FDA regulations and ICH guidance documents.
• Experience with various manufacturing/filling processes associated with non-sterile drug products.
• Experience in trouble-shooting and conducting investigations.
• Strong written, verbal, and interpersonal communication skills, with a focus on technical writing.
• Strong computer knowledge also required.
• 20% business travel required to external Contract Manufacturing Organization (CMO) Business Partner sites, or to attend professional development training seminars - as needed / directed.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Kyle Weber at (+1) 646-367-2618 or upload your resume on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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