Manager, Quality Assurance, Pharma QP Operations

Manager, Quality Assurance, Pharma QP Operations

BMS - Bristol-Myers Squibb

Dublin, Ireland

Key Responsibilities

• Directly support Qualified Persons within the QP team carrying out final release to market.
• Compile batch release documentation into QP pack for review by the QP.
• Complete QA Manager batch review checklists.
• Identify and resolve batch release documentation issues.
• Manage change controls, deviations and corrective actions associated with QP group activities.
• Generation and maintenance of Batch Certificate templates.
• Support cross-functional projects and continuous improvement initiatives.
• Generate and coordinate metrics programs in relation to QP group activities.
• Support QP activities relating to new product introduction, product launch preparation and technology transfer.
• Provide support as needed to the BMS Fact Finding (FF) and Product Review Committee (PRC) processes for major investigations involving Third Party products.
• Provide quality/compliance support as needed to the wider cross-functional Virtual Plant Teams.
• Provide quality support as needed to Global BMS functional groups such as Global Regulatory/CMC and the local country based regulatory managers in support of regulatory filings, product renewals, regulatory agency questions etc.
• Assist in the review of Quality Agreements with the Third Party Manufacturers and Alliance Partners.
• Support the Global BMS internal self-inspection program.

Qualifications & Experience

• Minimum 2 years experience in a regulated environment, preferably the pharmaceutical industry in Quality, Manufacturing Technology, Regulatory or a position within a Health Authority Agency.
• A BSc in a scientific discipline.
• Knowledge of cGMP regulations pertinent to the USA, EU and other international markets.
• Proven time management, organization and task prioritization skills.
• Ability to develop cross-functional and external working relationships.
• Strong communication and presentation skills.
• QP Eligible (desirable).

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Ireland      Manufacturing and Logistics      On-site      Quality Assurance      BMS - Bristol-Myers Squibb