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Director, Quality Assurance and Compliance Job West Point United States,  


Posted on : 27 April 2017

Project Description

Director, Quality Assurance and Compliance-QUA005800DescriptionMerck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and 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 an individual 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, Quality Assurance and Compliance reports to the Quality Operations Line of Business and supports all Quality Assurance and GMP compliance activities relating to the manufacture of vaccine products to ensure compliance with all applicable regulations and specifications.1. Ensure Division Quality systems are effectively deployed to sites in the Operating Unit according to schedule. Evaluate site variances and ability of site to maintain level of compliance through the requested extension. Confirm closure according to plan.2. Team with Site Compliance Directors in areas of compliance to proactively identify initiatives and quality system enhancements. Identify areas of continuous improvement for simple lean Quality system deployment (MPS) and ensures best practice sharing and drive improvement across sites. Champion various compliance initiatives according to Operating Unit and MMD priorities, as directed.3. Maintain, communicate and evaluate the performance metrics of key Quality Systems and Quality Assurance programs across sites as per the drivers of KPIs as identified by Operating Unit/MMD, including but not limited to:a. Change Controlb. Deviation Reductionc. Inspection readiness and performanced. Agency reporting of BPDRs and FARs, and market actionse. CAPA and Commitment management4. Support and contribute to internal and external compliance forums to identify and evaluate emerging trends for continuous improvement in Operating Unit related to Quality Systems requirements. These activities include:a. RegIntel to leverage and drive improvements from significant investigations and/or current compliance trends with Merckb. Attendance and participation in internal quality forumsc. Participation in industry working groupsd. Support enhancement of Operating Unit compliance performance through coordination with site compliance leaders5. Act as the primary liaison for Quality Operations Unit leader assisting sites in complex compliance issues such as significant investigations and Fact Findings.6. Support sites, as needed, during regulatory inspection and Divisional audits. This includes driving cross-site proactive approaches (mock inspection prep work and Quality Compliance & Excellence (QC&E). Assist in conduct of inspections, as needed, and assure responses are of high quality and represent both site perspective as well as Division perspective7. Support Quality Operating Unit leader and sites to ensure high quality FARs, BPDRS, EU defect reports and on-time submission.8. Serve as supporting member of Quality Standards Committee (QSC) by coordinating Operating Unit perspective on MMD policies and guidelines, and conversely, providing perspective of QSC to sites. Guide sites on implementation of Quality Alerts and Quality Bulletins9. Support sites and Quality Operating Unit leader on fact finding and any recall activities by guiding sites on the preparation and follow-up of key activities, most notably follow-up actions from these meetingsQualificationsEducation Minimum Requirement:- Bachelor's degree in an appropriate scientific or engineering field of study is required. Preferred fields of study include Biology, Biochemistry, and Microbiology. An MBA or other business degree, in addition to the required science or engineering education, is a plus.Required Experience and Skills:- At least ten (10) years of work experience in a pharmaceutical and/or vaccine manufacturing environment or strongly related, similarly regulated field.- Strong understanding of cGMPs across multiple global regulatory agencies.- Strong compliance mindset.- Strong lean mindset with prior MPS/Kata capabilities is a plus.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. Our Company 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. If you need an accommodation for the application process please email us at staffingaadar@merck.com.Search Firm Representatives Please Read Carefully:Merck & Co., Inc. 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.Visa sponsorship is not available for this position.For more information about personal rights under Equal Employment Opportunity, visit:EEOC PosterEEOC GINA Supplement Merck is an equal opportunity employer, Minority/Female/Disability/Veteran  proudly embracing diversity in all of its manifestations. Job: Quality OperationsJob Title:Dir, QualityPrimary Location: NA-US-PA-West PointEmployee Status: RegularTravel: Yes, 20 % of the TimeNumber of Openings: 1Shift (if applicable): 1stCompany Trade Name:Merck Nearest Major Market: Philadelphia Job Segment: Biochemistry, Microbiology, Compliance, Manager, Engineer, Science, Legal, Management, Engineering

Locations

West Point, PA, US

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