Director Quality Assurance

Director Quality Assurance - Drug Delivery Devices Job

Director Quality Assurance - Drug Delivery Devices-QUA002619 Description Merck is a global health care leader with a diversified portfolio of prescription medicines, vaccines and consumer health products, as well as animal health products. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us. Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of people like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career. The Director of Device Quality Assurance will be responsible to develop and establish Quality business processes in support of the global device strategy for the entire portfolio of injectable proteins /biologics / device combination products (Merck BioVentures). The Director of Devices Quality Assurance responsibilities include but not limited to: * Establish a Quality plan and strategy * Establishing the QA methodology, processes and procedures to follow by MMD * Work in partnership across the organization (MRL, MMD, Commercial) and management levels to understand the requirements for each device and document the appropriate test accordingly. * Partner with Device teams in the evaluation, selection and management of third party testing resources supporting devices * Prepare regular management progress reports for QA devices * Partner with Device Regulatory Lead and Sr Director of Device for determining and recommending to Sr. Management when a device is ready for different stages (sourcing, testing, manufacturing) * Participate in audits of device component manufacturer. Make coordination with Division accordingly. Qualify and monitor Device component manufacturer * Involve and provide input with Quality Agreements with device component manufacturer in partnership with Procurement * Establish requirements for device specs and internal/external device validation. * Partner with sites to oversee quality assurance for Final assembly quality control * Establish Quality test plan requirement * Ensure and maintain internal and external change control process of device * Prepare FMEA master plan * Establish a robust process to manage enquiry and device complaints management system including to reach 3rd parties * Establish a documented process to evaluate risks and mitigation plans prior to launch a device product. Ensure there is a process to manage and follow up corrective actions as part of complains management. * Will be current of new device regulations and will build relationship in support of Regulatory advocacy. Qualifications Education Requirements: BA / BS Degree (Engineering, Biological Sciences, Chemistry, Life Science/Science) Preferred Education Requirements: MS / MBA / PhD degree Required Qualifications: At least 8 years of QA experience with a minimum of 5 years recent experience with delivery device development and approval Knowledgeable and track record of QA methodologies, tools and processes Experience with development / approval of biologic injectable delivery devices Ability to travel up to 35% of the time Preferred Qualifications: Lean Six Sigma Certification Our employees are the key to our company's success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Merck's benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. merck.com/careers to create a profile and your resume for requisition # QUA002619. Merck is an equal opportunity employer, M/F/D/V - proudly embracing diversity in all of its manifestations. Search Firm Representatives Please Read Carefully: Merck is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via-email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means. Primary Location: US-PA-West Point Employee Status: Regular Travel : Yes, 25% of the time Number of Openings: 1 *This job post was placed on PharmaDiversity Job Board with permission of this employer. If viewing this post anywhere else, the "apply" click should lead you to PharmaDiversity Job Board for authentic job post view with direct employer application. For application attention if web source is requested please use "PharmaDiversity" or "PharmaDiversity Job Board". Merck prefers that you apply to this job directly on their site