Cache of job #13868502

Job Title

Global Product Quality Manager

Employer

Hrm

Location

Dublin

Description

With circa 30,000 employees and medicines in over 175 countries, this innovatory remains one of the leading biopharmaceutical organisations globally with revenues exceeding 25 Billion in 2017. With the stability, resources, expertise and passion to discover, develop and bring to market ground breaking science to solve the biggest health problems that face the world today and tomorrow, it is no wonder that this organisation remains one of the top employers in the industry here in Ireland with numerous best places to work awards. Due to continued growth, a new position in the organisation has arisen for a CMC Global Product Quality Manager to manage the organisations third party manufactured product portfolio. The Position: Maintains the primary quality lead with management oversight for project Quality activities and the team members.Primary driver for the quality, risk management, and compliance aspects of product transfers and organisation optimisation. Leads the development of global Product Quality Assurance strategy to support pharmaceuticals, biologics, device and combination products produced at business owned plants as well as third party manufacturing (TPM) facilities. Makes key decisions on product quality and compliance and regulatory conformance issues for sterile, biological, liquid, solids, and/or device products and elevates medium and high risk events to management. Establishes and maintains relationships and open communication with Third Party Manufacturers, business owned plants, affiliates and other functional groups to maintain roles and responsibilities, identify potential projects and issues, obtain an in-depth understanding of the quality, compliance, and resource needs at each site and provide guidance on quality concerns. Primary quality contact with Supply Chain and R&D for new products to be manufactured at TPMs. Acts as a resource for TPMs to evaluate and interpret industry regulations, assess risk, and develop an implementation strategy as the regulations relate to Operations domestically and internationally. Interfaces with Quality Assurance audit team to develop audit plans, due diligence plans, and inspection readiness plans, review audit observations and responses, and maintain corrective action timetable. Provides support for quality audits, initial site approvals and due diligence activities. Leads and manages pre-approval inspection readiness as related to the third party manufacturers to ensure regulatory approvals are obtained, with no delays to market entries. Manages Quality Assurance elements needed to facilitate new product launches including Third Party Manufacturer's that provide products directly to distribution centers, or to AbbVie domestic and International plants for further packaging and/or testing. Drives implementation of the Product Transfer Process from R&D to manufacturing sites. Develops product quality transfer process monitoring metrics. Manages small teams of quality professionals as required and maintains departmental spend within budget. Supports the regulatory filings and marketing authorisation dossiers by developing and/or reviewing of chemistry, manufacturing and controls documents and Drug Master files/Certificate if suitability of monographs of the Ph. Eur. Documents. Work with Affiliates and Regulatory to prepare submissions and participate on emergency response team for all incoming submission deficiencies and questions. The Person: Bachelor's Degree in relevant Life Science or other technical discipline or equivalent job experience required. 8 years of total combined experience. At least 5 years in Quality Assurance Operations Management; 3 years in Operations, Research and Development, Regulatory or Consulting. Direct Plant experience in a Pharmaceutical setting is beneficial. Knowledge and a comprehensive understanding of some biological and/or pharmaceutical technologies (sterile, biological, liquid, ointments, devices, solid tablets and caplets, suspensions, granulations, soft elastic capsules, gel caps, extended release products, coating solutions, and/or active pharmaceutical ingredients. To learn more apply on line or call Shane Browne on 353 1 6321865. This job originally appeared on RecruitIreland.com.

Date Added

2226 days ago

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