Merck Gruppe - MSD Sharp & Dohme | Associate Director, ...

Job Description We have an exciting opportunity for Associate Director, External Quality . The successful applicant will be accountable for all activities at the External Entity (EE) site associated with the manufacturing of Company products which includes quality oversight over manufacturing, testing, packaging, storage, and distribution of the products manufactured at an EE and to assure they have been produced or tested following approved processes/methods in conformance to all applicable regulatory requirements, regulatory filings, and company policies. The incumbent will also ensure that effective and robust Quality systems are followed to comply with required regulations, policies and guidelines governing the External manufacture of materials for the Company (e.g. small molecules, therapeutic proteins, biologics, vaccines, devices, combination products, sterile product, excipients, active pharmaceutical ingredients, intermediates, seeds and cell banks) through direct oversight, support and technical advice, counseling to site leadership, and on-site supervision. The AD may serve as a subject matter expert for EQA and Division in specific Quality systems, technology platforms, regulatory expectations and/or EE management, and can represent the Company in forums on their area of expertise (both internal & external). Role Profile May manage a team of Quality Assurance professionals as direct reports. Holds regular 1-on-1 meetings and Employee Development Plan discussions. Accountable for executing the performance management process including objectives setting, objectives approval, objectives revision, year-end accomplishment evaluation, and performance discussions with direct reports, when applicable. Contributes to development of the EQA budget and tracks and controls expenses as needed to meet EQA budget. Exhibits our company Leadership Behaviours 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, analysed, and reported, including identification of trends and/or root cause(s) to help develop new initiatives and process improvements. May sponsor the interpretation and aggregation of financial/business data for EQA and highlight concerns as appropriate to EQA Management. Identifies and facilitates resolution of major deviations from financial or strategic plans. Coordinates the development, with the EQA Senior staff, of the EQA budget, Long Range Operating Plan, workforce planning, and other strategic activities as required. Analyses headcount data to provide budget forecasts to management. Accountable for oversight of an 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. These 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. This also includes building effective quality systems at the EE and continuous improvement activities. Manages workload within team scope. Operates in a safe and efficient manner and in compliance with the Safety and Health Policy. Amount of Travel Required: Ability to travel up to 25%, occasionally on short notice. Your profile Education: Minimum four-year degree in Science, Engineering, or other relevant technical discipline (e.g. BS/MS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering or equivalent preferred). Minimum of 10 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. Must have strong interpersonal, communication, coaching, motivation, negotiation, and persuasion skills to build strong relationships. Must have Sterile External Manufacturing experience. Ability to work across boundaries; demonstrated interpersonal, relationship building and leadership skills. Communicates in English, both verbally and in writing. Preferred Experience and Skills: Prior management experience preferred. Moderate level of contractual and financial awareness. Previous experience participating in regulatory inspections. Be conversant with all domestic and foreign regulations and compendia governing plant operations. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs. We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. So, if you are ready to: Invent solutions to meet unmet healthcare needs, Impact the future by driving one of the world's leading healthcare companies, and inspire your team to reach their full potential and push the boundaries of science and technology, please apply today. 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: No relocation VISA Sponsorship: No Travel Requirements: 25% Flexible Work Arrangements: Remote Shift: 1st - Day Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 12/10/2024 *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: R315197 #J-18808-Ljbffr

Created: 2024-11-29