Sr. Specialist, Data Integrity Champion

Employer
Merck
Location
Durham, NC, US
Posted
May 09 2018
Discipline
Other
Organization Type
Pharma
Requisition ID: QUA007348

 

Merck & 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. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.


Merck Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe. 

Position Description:

 I. GENERAL SUMMARY: The Sr. Specialist, Data Integrity Champion is responsible for oversight of the implementation and communication of Agency and MMD DI requirements within the Merck’s Durham, NC Vaccine manufacturing facility.  The responsibilities of this role are to implement and maintain the DI Quality Management System, communicate pertinent DI information, support DI training, and promote a healthy Data Integrity Culture.  The role will require, working closely with Quality and the Data Integrity Center of Excellence organizations at the global and local level to ensure regulatory compliance. II. GENERAL PROFILE:
  • Works in an empowered, self-directed culture with independent decision making in the planning, coordination, and execution of multiple activities and projects.
  • Maintaining an active dialog and communicating between affected departments and leadership to ensure project progress and milestone success.
  • Responsible for effective document review and conformance to Merck Manufacturing Standards, MMD Quality Policies, cGMPs for the generation and approval of the required documentation and testing.
  • Coordinating and possibly performing in-process assessments of new systems and periodic inspections with remediation  of existing systems.
  • Trains user community on the application of best practices and pertinent (Data Integrity and Systems Development Life Cycle) SDLC topics.
  • Develops, reviews and approves site procedures and reviews updates to divisional guidelines.
  • Responds to divisional initiatives and Quality Alerts.
  • 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.
  • Provides instructor based training sessions to Merck personnel pertaining to Data Integrity requirements.
  • Create and maintain quality based metrics to be shared to the Site  Leadership Team.
  • III. BUSINESS EXPERTISE:
  • Understands the fundamental business drivers for the company; and uses this knowledge in own work
  • Understands and applies regulatory / compliance Data Integrity requirements
  • IV. FUNCTIONAL EXPERTISE: The Sr. Specialist, Data Integrity Champion will be responsible for activities that support regulatory and cGMP compliance programs and initiatives to include the following:
  • Sub system owner for the Data Governance and GMP Records topic, and point of contact for the DI COE
  • Support development and implementation of DI Global Procedures (workshops, document reviews, pilots, deployment and implementation)
  • Point person(s) for coordination and deployment of global procedures within the site/functional area
  • Responsible for collection and presentation of DI compliance (metrics), obstacles and challenges to site management, including a review of the DI topic at the Site Quality Council Meeting per the QC standard
  • Development and oversight of the annual DI work plan / coordinates between site/functional management, site/functional SMEs and DI COE
  • Implementation of a DI GEMBA program within site / functional area
  • Supports site for DI Inspection Readiness / Inspection Responses for DI
  • Point person for integration of Quality Risk Management as it relates to data governance and GMP records
  • Informed of and support to site investigations, as needed, related to Data Integrity.
  • Active participant in DI Knowledge Management Forum / Community of Practice
  • Distribution of DI information within the site / functional area, and from the site / functional area to the DI COE
  • May participate in external DI forum
  • 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.
  • V. INFLUENCE / DECISION MAKING / PROBLEM SOLVING:
  • This position has an influence on the continuous acceptance of existing and new products at the Durham site through support of Automated Systems implementation and maintenance 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 on the handling of data, automation implementation and changes to ensure the appropriate documentation and testing is performed.
  • Represent the Durham Site at the Community of Practice meetings.
  • This role requires interactions with personnel at all levels across multiple functional areas and above site teams to ensure timely completion of Quality Compliance responsibilities.
  • Assist with Quality oversight of computer system validation activities.
  • Development and maintenance of robust site-wide systems to govern the process / configuration data and the impact to computerized systems (e.g. change control, incident and deviation management, etc.).
  • Qualifications

     Position Qualifications:

     Minimum Requirement:
  • Bachelor's degree in Science, Engineering, or Business or equivalent area of study with at least eight (8) years of experience working with computerized systems regarding Process Data, Configuration Data, documentation and testing in supporting the manufacturing in a GMP environment.
  • Master's degree in science, engineering, or business or equivalent area of study with at least six (6) years of experience working with computerized systems regarding Process Data, Configuration Data, documentation and testing in supporting the manufacturing in a GMP environment.
  • PhD in science, engineering, or business or equivalent area of study with at least four (4) years of experience working with computerized systems regarding Process Data, Configuration Data, documentation and testing in supporting the manufacturing in a GMP environment. 
  • Required Experience and Skills:
  • Understanding of FDA regulations/guidance, various GAMP guidance documents, the System Development Life Cycle (SDLC) validation methodology, Data Integrity requirements and how they all work together
  • Familiar with automated data generating systems used within pharmaceutical manufacturing and Laboratory environments
  • Experience with different types of validation testing
  • Experience with Quality systems including change control, incident 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:
  • Knowledge of the manufacturing and laboratory processes and support systems across the Durham organization.
  • Familiarity with the data configuration and data flow for systems such as:  PAS-X, DeltaV, PI, RtReports, BAS, AIMS, GUAVA, SCM and SAP
  • Knowledge of CFR, Eudralex and other regulatory guidance specific to the pharmaceutical industry.
  • 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 
  • Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.  If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to 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 Poster            EEOC GINA Supplement 

    Job: Quality Operations
    Other Locations:
    Employee Status: Regular
    Travel: Yes, 10 % of the Time
    Number of Openings: 1
    Shift (if applicable): 1st
    Hazardous Materials: No
    Company Trade Name: Merck

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