Associate Director EQA DDS

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Job DescriptionAn amazing opportunity has arisen for an Associate Director in External Quality. The position is responsible for implementing Quality Assurance policy and discharging Quality responsibilities for the oversight of contract manufacturing organizations that supply medical device components or combination products.What you will do: Bring energy, knowledge, innovation and leadership to carry out the incumbent will exercise a leadership role in monitoring and maintaining contracted third-party compliance with the FDC Act, Current Good Manufacturing Practices Regulations (domestic and foreign), and other pertinent legal requirements.Quality oversight of contract manufacture, testing, packaging, storage, and/or distribution of pharmaceutical products and medical device components; executed under the direction or on behalf of the External Quality Assurance Director.Assuring that products are manufactured from approved processes in conformance to all applicable regulatory requirements and Company policies and may include the release of manufactured products.The incumbent ensures the quality performance of Contract Manufactures through direct oversight, support and technical advice, counselling to the third-party site senior leadership and providing on-site supervision as appropriate.This may include participation in activities such as third-party selection, GMP Due Diligence, and establishing of Quality Agreements.The incumbent also provides support to build effective Quality Management Systems and drive continuous improvement activities at the Contract Manufacturer, in particular related to medical device component and/or combination product regulatory expectations; and maintains compliance with the Quality Agreements between the parties.The incumbent is expected to drive collaboration within internal and external cross-functional groups to achieve objectives and communicate company expectations as necessary to improve relationship performance against agreed upon metrics and business goals.What skills you will order to excel in this role, you will more than likely in Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering, or related disciplines is required.A minimum of 8 years of experience working in the Pharmaceutical industry, with strong knowledge of and broad experience in Quality Assurance and Quality Control activities, particularly applied to drug delivery systems, medical devices and/or combination products.Experience in Quality Agreement development and cross-functional teamwork is required. Familiarity and experience in the application of ISO 13485 and ISO 14971 is also required.Strong demonstrated communication skills.Prior experience managing 3rd Party relationships preferred.Demonstrated personal networking and relationship building skills.Conversant on domestic and foreign regulations and compendia governing manufacturing operations particularly applied to drug delivery system/medical device Quality Management Systems.Experience in Quality oversight of plastic moulding operations or combination product manufacture preferred. Contractual and financial awareness is preferred.Experience in Lean project implementation also preferred.Experience in Project Management is preferred.As a company, we are committed to 'Inventing for Life' in all that we do. 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.Search Firm Representatives Please Read CarefullyMerck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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: RegularR relocationVISA Sp Req Work Arr IndicatedValid Driving Material(s):Number of Openings: 1

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