Job Description
Executive Director, Quality This role will be based on-site at Brinny, in Cork, Ireland.
Purpose of Role: The Executive Director, Quality Operations, reports to the Vice President Vaccines Quality and provides strategic direction and leadership to the Brinny Site Quality Operations organization. Directs all quality related functions at the site including Quality Control (QC) testing and release, auditing, product release, environmental monitoring, and GMP compliance for vaccine drug substance manufacturing/testing and vaccine drug product testing. Ensures that products are manufactured in compliance with all regulatory guidelines and standards and facilities innovation and continued improvement. Employs risk management based on scientific knowledge and protection of the patient.
Activities Within Role include: Provides direction and leadership to the quality leaders of the manufacturing areas, laboratories, and quality assurance of the Brinny Vaccines Manufacturing Site. Key activities include developing a strategic vision, managing headcount, profit plan and capital plans.Ensures that the laboratories execute testing compliant with external regulatory guidelines, compendia, and internal GMP standards. This includes testing programs for raw materials, in-process materials, drug substance, and drug product.Ensures that the departments have the resources needed to perform all Quality Assurance activities required to maintain product quality.Ensures that all products released to the market are manufactured within regulatory and internal standards.Assists departmental personnel in resolution of any significant Quality Assurance and Quality Control activities, including deviation investigations, customer complaint investigations, and issuance of regulatory notifications.Serves as a liaison with regulatory agencies during inspections. Ensures that all regulatory inspection observations are addressed in a complete and effective manner.Is responsible for approving all Biological Product Deviation Reports for the Brinny site.Ensures capital projects and new product introductions meet regulatory and internal GMP standards.Ensures Quality Organization is compliant to safety policies and all operations are carried out in a safe manner.Works directly with plant manager on issues ranging from tactical/troubleshooting to strategic decisions.Serves on a number of management teams. Provides consultation to the VP, Vaccines Quality, on general quality issues. As needed, represents the quality function on divisional project teams.Responsible for driving a culture of Continuous Improvement by deploying the Company's Continuous Improvement System within the Quality Department.Develop an effective team by understanding their abilities, unique contribution and broadening their skills to be agile and prepared for any future business requirements.The successful candidate will have the following skills and experience: 10+ years of experience in quality and manufacturing operations.Experienced in vaccine or therapeutic protein manufacturing.Experienced in leading domestic and international health authority inspections.Preferred: Experience in site-based manufacturing and quality operations managerial roles, experience at multiple sites.BSc in related field (Biology, Chemistry, Engineering). Advanced degree preferred.QP Qualification, desirable.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: Not Applicable
Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 10/16/2024
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID: R300576
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