Senior Specialist, Quality Compliance

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.The Senior Specialist position in Quality Compliance is responsible/accountable for Deviation Management, CAPA management, Product Quality Complaints (PQC), and Adverse Event (AE) investigation activities that support the Durham Vaccine Manufacturing Facility. The incumbent serves as a member of a team responsible for instituting consistent practices across the Durham facility in the disciplines of Deviation Management, CAPA management, Product Quality Complaint investigations, Adverse Event investigations, and metric generation. Quality System or GMP Walk-Through Audits, Annual Product Review support, Change Control support, SOP approval, Permanent Inspection Readiness projects, and direct regulatory inspection support are additional areas of focus.The incumbent will provide hands-on assistance in the development, implementation, and monitoring of Deviation Management and CAPA management. Additionally, the incumbent will be responsible for conducting and supporting customer Product Quality Complaint investigations, Adverse Event investigation, and Quality systems metric generation. By providing administrative support, the successful candidate will assist the Director and Associate Director with building and/or improvement of programs by defining requirements established via in depth review of existing Deviation/CAPA Management and Complaint/Adverse Event Quality Systems, which will be done in concert with strategic direction facilitated by our global business model and regulatory compliance. The incumbent will also be responsible for development of metrics, ensuring consistency across the site, and presenting systems during audits and inspections.Primary ResponsibilitiesGeneral

Assist in Permanent Inspection Readiness (PIR) projects

Author and/or Support Annual Product Review

Investigation of Product Quality Complaints (PQC) and Adverse Events (AE)

Support of Biological Product Deviation Report (BPDR) submissions to FDA associated with PQC, AE, or site Significant Deviations

Quality review and approval of Deviations and CAPAs associated with Vaccine Manufacturing Facility and presenting investigations during regulatory inspections

Assist in the reporting and assessment of critical data by indexing, archival, and retrieval of Deviation/CAPA and Complaint/Adverse Event System data

Responsible for identification of trends, ongoing monitoring of the system, and providing recommendations for continuous improvement

Serves as Subject Matter Expert (SME) for areas of responsibility

Perform SOP development and review / Quality approval

Direct support of regulatory inspections and audits; defends Quality Systems, Deviations, CAPAs, Complaints, and Adverse Events during regulatory inspections

Provide daily maintenance, review and oversight of Deviation Management/CAPA and Complaint/Adverse Event System data throughout the document lifecycle

Perform data analysis and metrics to ensure quality of the Deviation/CAPA & Complaint/Adverse Event Management System programs

Assist in evaluating existing Deviation, CAPA and Complaint/Adverse Event systems on the global and local level and assist in the implementation of consistent management process across the site

Business Expertise

Applies management skills to align staff activities with department objectives

Understands and applies regulatory/compliance requirements

Functional Expertise

Working knowledge of Trackwise, SAP, Word, Excel and Power Point; good understanding of database concepts, theory and architecture

Understanding and ability to perform metrics; working knowledge of and/or experience with Deviation/CAPA Management and Complaints/Adverse Event investigation systems from a Regulatory/Quality perspective is required

Electronic document control systems experience is highly desirable

Understanding of the FDA regulations and cGMPs with experience in document control and quality management in a highly regulated industry; experience in a high-volume, mission critical environment and excellent communication skills

Problem Solving

Identifies and resolves technical and operational problems; collaborates with peers to resolve problems that cross into inter-related units

Impact

Influence: Explains difficult concepts and persuades others to adopt point of view and communicates information, asks questions and checks for understanding

Decision Making: Guided by policies and procedures – that impact the unit’s ability to meet performance objectives and consults on an as-needed basis with next-level manager on more complex decisions and/or issues that impact other units with inter-related processes

Strategic Planning

Adapts and implements departmental plans and priorities based on division scorecard to address local business, service and operational challenges

Resource Management

Forecasts resource needs; manages allocated budget

Education Minimum Requirements

Bachelor's Degree in Science, Engineering or related field of study

Required Experience and Skills

Minimum five (5) years of experience within in the Pharmaceutical industry in Quality, Technical, Manufacturing Operations, or related Business Operations working with Deviation Management, CAPAs, Product Quality Complaints, and Adverse Event investigations

Experience performing review and approval of Deviations and CAPAs

Knowledge of cGMPs, data management collection and analysis

Proven expertise of cGMPs, technical writing, data management collection and analysis

Demonstrated Quality, Technical, and / or Manufacturing experience in the areas of Deviation Management, CAPAs, Product Quality Complaints, and Adverse Event investigations

Ability to interpret complex business and/or technical documents, write comprehensive reports and detailed business correspondence, and the ability to present to groups across the organization as needed

Demonstrated knowledge of GMPs, compliance issues, inspectional trends, industry quality assurance practices, and systems

Demonstrated innovative mindset

Demonstrated cross cultural agility and resourcefulness

Proven expertise with Lean 6 Sigma methodologies

Preferred Experience and Skills

Lean Six Sigma Green Belt or higher certification

Significant experience in biologics, vaccines, and/or biopharmaceuticals compliance

Experience as Subject Matter Expert (SME) in presenting to regulatory agencies

Knowledge of Automation and ERP / Quality Data Management systems such as SAP, Trackwise, MIDAS, Emerson DeltaV, Allen Bradley PLC (or equivalent), MES (Manufacturing Execution System), and automated inspection systems

Quality Auditing experience

Working Relationships

Reports to Associate Director, Quality

Frequent interaction with employees from other departments

Interacts with representatives from regulatory agencies

Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that’s committed to delivering a high quality, reliable supply to customers and patients on time, every time.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 Only:If you need an accommodation for the application process please email us at staffingaadar@msd.comFor more information about personal rights under Equal Employment Opportunity, visit:EEOC Poster at https://www.dol.gov/sites/dolgov/files/ofccp/regs/compliance/posters/pdf/eeopost.pdfEEOC GINA Supplement​ at https://www.eeoc.gov/sites/default/files/migratedfiles/employers/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: R51540