Details
**Job Description**
Our 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 dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.
We are seeking a Growth and Improvement minded Associate Director | Digital Quality Laboratory Value Team Lead that can help drive our Strategic Operating Priorities.
+ Invent | Pursue the Most Promising Internal and External Science to Address Significant Unmet Medical Needs
+ Execute | Prioritize Resources Behind Our Key Growth Drivers (Oncology, Vaccines, Select Specialty Areas, Animal Health) While Optimizing Our Base Business)
+ Adapt | Develop Our People, Culture and Business Model to Evolve with a Dynamic Landscape
+ Diverse Talent | We are committed to providing an inclusive and welcoming environment with supporting leadership behaviors because having a high-performing, engaged workforce is critical to our ability to deliver innovative solutions to patients and customers around the world
+ Values and Standards | Our Steadfast Commitment to Our Values and Standards will Continue to Guide Us as We Take on New Challenges and Will Always be Fundamental to Our Success They are a Competitive Advantage for Us
**Summary, Focus and Purpose**
The Digital Manufacturing Division (DMD) Team operates as a strategic systems delivery and management unit supporting global manufacturing, specifically the Quality Control Laboratories. The focus of this role is to provide strategic platform management that drive GLIMS system performance and configuration in line with strategic business imperatives. This role provides direction and oversight for the team responsible for the GLIMS platform ensuring that the system is managed in accordance with regulatory and corporate mandates, and that the configuration of the system and focus of the team are directionally aligned with the strategic direction of both the DMD and Quality Control organizations. We collaborate internationally to deliver the services and solutions that help everyone to be more productive and enable innovation.
The Associate Director | Digital Quality Laboratory Value Team Lead is a leadership role within our Company Digital Manufacturing Division, manages the team responsible for maintaining the Global Laboratory Information Management System, (GLIMS) including core and custom configuration, integration, and hardware in a validated, inspection ready condition. This system is designed to accelerate data-driven decision making in the Quality Control Labs as well as preserve the data, integral to ensuring that our patients are receiving the highest quality products available.
This role is a resource manager role that involves collaborating with cross-functional stakeholders and ensuring the timely and accurate delivery of enhancements, performance, architectural design, data structure, integrations and a strategic roadmap for the GLIMS system.
You will work collaboratively with business and IT leaders throughout our Company. The position will serve as a member of the extended Digital Manufacturing Division leadership team and will have accountability across the entire scope of QC Laboratory processes, as well as direct reporting accountability for the GLIMS technical team within the Digital Manufacturing Division organization.
**Key Functions**
+ Lead a Team of dedicated Value Team, Information and Business Architects, who will use agile, value-centric, and business outcomes-oriented approaches to ensure performance, data security, and systems management of the GLIMS platform
+ Create and sustain a governance process for GLIMS enhancement demand and associated investment activities across Digital Manufacturing Division with strong alignment to key strategic programs (such as our Manufacturing Division Accelerate), ongoing lifecycle management activities and total cost of ownership principles
+ Deliver a strategic roadmap for the GLIMS platform that aligns to global QC Laboratory strategic direction and supporting business directives
+ Provide guidance and leverage expertise to ensure GLIMS system configuration is managed and delivered according to regulatory and corporate expectations
+ Collaborate with DMD data and Method owners to ensure that the platform is configured to drive efficient utilization by the business, integrations supporting automated data management and data security
+ Be a trusted partner for Quality Control business stakeholders and help identify, prioritize, deliver, and measure impact of GLIMS enhancement projects that support business objectives
+ Work closely with product owners to understand business requirements, translate it to technical requirements, rapidly assess feasibility, and ensure smooth transition to GLIMS team for updates
+ Manage relationships with systems and service delivery vendors, ensuring that vendors meet performance metrics and contractual obligations
+ Apply compliance/validation requirements related to GxP-regulated applications
+ Steer as a thought and execution lead for moderate to large initiatives of varying complexity
+ Act as a mentor for junior team members within Digital MD, fostering a culture of innovation, collaboration, and continuous improvement
+ Develop and implement data governance policies and procedures to ensure compliance with regulatory requirements and industry standards
+ Embrace agile product development methodology and manage the project lifecycle, including scoping, planning, execution, and delivery of technology-enabled solutions
+ Stay current with industry technology trends, cross industry architecture standards and introduce best practices to Digital Manufacturing Division. Ensure our Company takes an active role in developing and sustaining the relevant industry standards
+ Effectively work with both waterfall and agile project teams to evolve the technical landscape toward the desired end state
+ Prepare and deliver executive level briefings and communicate complex topics effectively to a diverse executive audience
+ Travel will be required (~10-25%)
**Education**
+ Bachelor Degree in Computer Science, Science, or a related study
**Experience | Skills | Knowledge**
Required
+ Five plus years in a leadership position and ten years plus supporting Quality Control operations
+ Five plus years experience managing LIMS systems in a GxP environment
+ Demonstrated application of computer validation and change control
+ Demonstrated systems management experience
+ Demonstrated Project Management experience
+ Understanding of overall pharmaceutical supply chains and line of sight between laboratory systems and other manufacturing systems (MES, ERP, SmartQC, etc.)
+ Working knowledge of Cloud, SaaS, and modern Analytics and data integration architecture, platforms, and solutions
+ Good understanding of end-to-end Manufacturing business processes and value streams inclusive of Quality and Supply chain
+ Demonstrated ability to partner with business stakeholders and navigate across conflicting priorities to balance critical tactical and strategic needs
+ Principled written and verbal communication skills able to effectively communicate complex concepts in simple ways
+ Demonstrated ability to effectively collaborate and communicate with a variety of audiences and stakeholders including executive management, business leaders, IT peers, and colleagues worldwide
+ Strategic thinker, with demonstrated ability to work in a broad and top-down manner with a fair amount of ambiguity
+ Results-orientation with the proven ability and reputation for developing plans and implementing them successfully
+ Demonstrated leadership in achieving shared objectives in a matrix organization, managing cross-divisional initiatives, and cross-functional teams in an extremely dynamic environment
+ Self-directed, self-motivated, focused leader who with little direction can fill in the gaps as to what is needed, and drive expected results
+ Demonstrated ability to envision the future and rally the organization/people towards a common goal
Preferred
+ Certified LabWare administration experience
+ Prior experience with automated data management and systems integration for GxP Quality Control labs
+ Prior experience in the pharmaceutical industry, with specific experience in IT and/or Quality and Quality Control areas ideally involving cross industry collaboration to drive best practices
+ Experience in developing Process and Master Data Management strategies
+ Experience in integrating real time shopfloor and lab systems, at an enterprise level, with appropriate levels of resiliency and performance
+ Experience in manufacturing analytics systems, including supply and demand forecasting, biologics process modelling and advanced image analysis
+ Understanding of regulatory requirements that drive IT and OT delivery, including 21-CFR-Part-11, Annex 11, Good Manufacturing practices, Computer Systems Validation, track and trace, and other global regulatory requirements that impact IT and OT systems in the manufacturing and supply chain space
+ Exposure to multiple, diverse technologies and processing environments
+ Knowledge of business process re-engineering principles and processes
+ Strong understanding of application development methodologies
Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network thats devoted to delivering a high-quality, reliable supply to customers and patients on time, every time.
**NOTICE FOR INTERNAL APPLICANTS**
In 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.
**Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.**
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Under New York City, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidates relevant skills, experience, and education.
Expected salary range:
$130,960.00 - $206,200.00
Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here ( .
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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, 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:**
Regular
**Relocation:**
No relocation
**VISA Sponsorship:**
Yes
**Travel Requirements:**
25%
**Flexible Work Arrangements:**
Remote Work
**Shift:**
1st - Day
**Valid Driving License:**
No
**Hazardous Material(s):**
N/A
**Requisition ID:** R242104