06 Jun
Quality, Senior Specialist
North Carolina, Durham 00000 Durham USA

Vacancy expired!

Job DescriptionOur Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.GENERAL SUMMARY:The Sr. Specialist, Supplier Quality Management is accountable for maintaining regulatory compliance for the supplier change management systems at our Company’s Durham, NC Vaccine manufacturing facility. The incumbent will be part of a site-wide team providing Quality oversight of all supplier quality management systems. The role will require working closely with Quality, Technical, Regulatory CMC, Global Auditing, Vendors and IT organizations at the global and local level, primarily in support of capital projects at the site.GENERAL PROFILE:

Works in an empowered, self directed culture with a great deal of independent decision making in the planning, coordination, and execution of multiple independent projects.

Maintaining an active dialog and communicating between affected departments and leadership to ensure project progress and milestone success.

Responsible for supplier initiated change requests and supplier document review to ensure conformance to our Company Manufacturing Standards, our Manufacturing Division Quality Policies, cGMPs and development and maintenance of Quality Technical Agreements.

Responsible for supporting supplier audits.

Trains site system users to function as Quality, Technical, Operations, Change Owners within the supplier management systems.

Develops/maintains site procedures and reviews updates to divisional guidelines.

Analyzes and solves problems using standard problem solving processes.

Applies team effectiveness skills, listening and integrating diverse perspectives from across the work group; contributes and adds value to the achievement of team goals.

BUSINESS EXPERTISE:

Understands the fundamental business drivers for the company; uses this knowledge in own work

Understands and applies regulatory / compliance requirements relative to their role

FUNCTIONAL EXPERTISE:The Sr. Specialist, Supplier Quality Management will be responsible for activities that support regulatory and cGMP compliance programs and initiatives to include the following:

Providing Quality oversight of all supplier-related activities so that they can be completed on schedule and in compliance with local procedures and industry standards.

Development and maintenance of robust site-wide systems to manage supplier-related activities.

Review and approval of supplier request and compliance documents supporting Good (anything) Practices systems and manufacturing processes including, but not limited to, change control documentation, vendor change notifications, Quality Agreements, and deviations.

Manages review and implementation of Vendor Change Notifications.

Functions as system steward for the following systems: Quality System Audit Tracking (QSAT) Trackwise (scope limited to supplier related changes), Supplier Transparency and TraceLink.

Represents site at global level for supplier management.

Reviews and approves SOPs as appropriate.

Support operational excellence initiatives targeted to increase the speed, flexibility and efficiency of processes as appropriate.

Performs special quality projects / investigations as requested by Senior Quality Management.

Other duties as requested by Quality management.

INFLUENCE / DECISION MAKING / PROBLEM SOLVING:

This position has an influence on the continuous improvement of existing and new products at the Durham site through support of efficient, effective supplier management systems that lead to the expansion of the Durham product portfolio.

The individual in this role is required to make real time decisions in a time constrained environment.

This role requires interactions with personnel at all levels across multiple functional areas to ensure timely completion of Quality Compliance responsibilities.

Education Minimum Requirement:

B.S., B.A., or M.S. degree in Science, Engineering, Business or a related field of study, or equivalent experience

Required Experience and Skills:

Minimum seven (7) years experience in Quality, Regulatory, Technical, or Manufacturing Operations.

A minimum of four (4) years of experience in GMP Quality Management or equivalent system in a regulated environment

Understanding of FDA regulations/guidance as related to change management and supplier management

Experience with Quality systems including change control, incident management, vendor management, and deviation management

Project management experience

Experience working with customers understanding concerns and challenges while applying regulatory compliance and company policy guidance and maintaining excellent relationships

Preferred Experience and Skills:

Knowledge of the manufacturing processes and support systems across the Durham organization.

Familiarity with the following systems preferred: Trackwise, Supplier Transparency and TraceLink

Knowledge of Code of Federal Regulations, Eudralex and other regulatory guidance specific to the pharmaceutical industry.

Experience with interacting with Regulatory inspectors during site audits.

Strong analytical and problem solving skills

Effective global communication skills (both written and oral)Ability to multitask and manage/prioritize multiple projects and deadlines

Strong customer service focus

Who we are …Merck & Co., Inc., Kenilworth, New Jersey, USA is known as “Merck” in the United States, Canada & Puerto Rico. We are known as “MSD” in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.What we look for …In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth .INVENT.IMPACT.INSPIRE.NOTICE FOR INTERNAL APPLICANTSIn accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.US and Puerto Rico Residents OnlyIf you need an accommodation for the application process please email us at staffingaadar@merck.comFor more information about personal rights under Equal Employment Opportunity, visit:EEOC Poster at https://www1.eeoc.gov/employers/upload/eeocselfprintposter.pdfEEOC GINA Supplement​ at https://www1.eeoc.gov/employers/upload/eeocginasupplement.pdfOFCCP EEO Supplement at https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdfOFCCP Pay Transparency Rule at https://www.dol.gov/ofccp/pdf/pay-transp%20EnglishformattedESQA508c.pdfWe are an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.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:RegularRelocation:No relocationVISA Sponsorship:NoTravel Requirements:10%Flexible Work Arrangements:Not SpecifiedShift:1st - DayValid Driving License:YesHazardous Material(s):N/ANumber of Openings:1Requisition ID: R55488

Vacancy expired!


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