Associate Director, External Quality Assurance - Louth

Job Description We are seeking a Growth and Improvement minded External Quality Assurance Associate Director that can help drive our Strategic Operating Priorities. Key Responsibilities

• Serve as the quality project lead for Technology Transfer, New Product Introduction and Analytical Transfers to Contract Manufacturing and testing sites (start-up facility).
• Assist in managing the end-to-end processes of transfers including but not limited to: Due Diligence, Feasibility Studies, Protocols/Reports, PPQ, PAI Readiness and Quality System Oversight Implementation.
• Accountable for oversight of an External Entity (EE) involving releasing of products for further processing with the assurance that the goods were produced or tested in conformance to all applicable policies and procedures of the Company and compliance with all governing regulations.
• Accountable for Quality Control functions including oversight for product testing, as well as other relevant components as determined by applied Calibrated Quality Oversight | Components may include review of batch documentation and deviation investigations.
• Ensures permanent audit readiness, regulatory inspection support and monitoring, effective complaint management, change control oversight, metric review, and review of annual product reviews | Includes building effective quality systems at the EE and continuous improvement activities.
• Exhibits our company Leadership Behaviors and provides a leadership example for the team.
• Assures compliance with established policies/procedures of the Division and Corporation and complies with all applicable governmental regulations (GMP, etc.) both domestic and foreign.
• Maintains and provides expertise on EQA systems, tools, data, and processes on an ongoing basis.
• Accountable for ensuring metrics are compiled, analyzed, and reported, including identification of trends and/or root cause(s) to help develop new initiatives and process improvements.

Education

• Bachelor's or master’s degree in a Science, Engineering, or related area of study with eight (8) years relevant experience in the pharmaceutical industry and/or biotechnology industry with a thorough knowledge of Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP and regulatory requirements

Required Experience:

• Experience with manufacturing operations and/or analytical expertise associated with biologics and/or vaccines. Aseptic manufacturing experience.
• Strong and principled interpersonal, communication, coaching, motivation, negotiation, and persuasion skills to build strong relationships.
• Ability to work across boundaries; demonstrated interpersonal, relationship building and leadership skills.
• Works independently, receives minimal guidance.
• Communicates in English both verbally and in writing.
• Local to the area, who will provide at least 3 days / week on-site support in the Louth area (Ireland), remainder at home.

Desirable Experience:

• Direct experience with managing external partners (CMOs, Labs, etc.)
• Experience with working with new product introductions / product transfers.
• Experience in batch disposition, deviation management, change control and participating in regulatory inspections.
• Moderate level of contractual and financial awareness.

Please note you will be required to be onsite 3 days a weekin the Louth area, remainder at home. Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Shift: Valid Driving License: Hazardous Material(s): Requisition ID: R261094#J-18808-Ljbffr