Director, Global Quality Management System

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 codependent global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

This position is critical in our Company effort to create a simplified, integrated, user-centric global Quality Management System (QMS) for our human health products, with the goal to enable consistently compliant product quality, continuous improvement and effective life-cycle management. The Director, Quality Management Systems, is accountable for providing global leadership and direction for the development and maintenance of processes, procedures and corresponding controlled documentation and systems within our QMS Quality Manual Chapter titled Quality Organization and Management Responsibility.

The QMS Chapter encompasses requirements and processes for assignments of management and of the quality organization to ensure that an effective Quality Management System is in place. The chapter covers requirements and processes to achieve the quality objectives, and that roles, assignments and governance are defined, communicated, and implemented. It also includes the requirements and processes for the Division Global Quality Plan, the Quality Councils, Delegation of Authority, the M anagement of Outsourced Activities and Purchased Materials, the Quality Risk Management, Business Continuity Planning and Early Management Notifications and Escalations.

This Director will guide one or more topics in the area. The Director is also accountable for ensuring the end to end end life cycle process for the QMS is well defined per the attributes of a quality system, there is a robust management system in place to monitor the process and that any gaps are identified and managed to completion.

Essential function(s) includes, but is not limited to:
  • Processes are defined with adequate Procedures, Governance, and clear Roles, Responsibilities and Accountability
  • The Organization and Infrastructure to support the execution of the processes are defined, installed and maintained
  • Metrics are developed and deployed for the ongoing evaluation to demonstrate that the system is working as intended, reviewed by the appropriate levels of management, and used as a basis for continual improvement


Responsibilities
  • Direct the design, development, implementation, and continuous improvements of the topic area within the Quality Organization and Management Responsibility chapter
  • Define the strategy for global requirements and procedures to drive harmonization of processes and systems across the network
  • Develop the content, implementation strategy and adequate performance indicators for the respective QMS topic
  • Lead cross-functional global teams developing content for the chapter, and interface with other chapters/topics, and stakeholders across the network as required
  • Work with (sub-) topic owners and subject matter experts to assess system performance and drive continual improvement
  • Ensure quality requirements are sound and compliant by using insights, experience and judgment to proactively drive and improve the company's QMS
  • Provide leadership and technical direction on regulatory requirements for the above in the GMP/GDP environment
  • Monitor global regulations with impact on assigned topics to develop and sustain accurate interpretation of regulatory requirements per market, in alignment with QMS policies and procedures
  • Help identify, resolve/mitigate or appropriately escalate any issues or delays in content development project execution, and ensure all targets are met on time, in full and to quality
  • Drive the development, implementation and realization of permanent inspection readiness for assigned topics
  • Lead the QMS plans for the digital implementation and application of risk management tools across multiple platforms as well as Quality Systems governance and continuous monitoring topics
  • Actively participate in pharmaceutical industry meetings/regulatory symposia etc. | Establish industry relationships, leverage industry best practices and benchmarking, stay abreast of regulatory trends, and implement action plans to proactively address potential GMP compliance impact
  • Co-own overall IT strategy for QMS topic. Drive the implementation and adoption of Management System Enterprise IT solution for QMS application as the business and process owner


Education Requirements
  • Bachelor's degree in science, engineering, or related areas of study.


Experience and Skills

Required
  • At least ten (10) years experience in the FDA and/or EU regulated pharmaceutical/biotech environment; preferably in a manufacturing site in leading manufacturing and/or quality roles and/or in Global Quality; experience in vaccines, biologics, devices are preferred.
  • Demonstrated leadership in Quality & Compliance discipline and in-depth knowledge of global health authority regulations and requirements, with the ability to effectively translate andcommunicate these requirements
  • Proven subject matter expertise in regulatory requirements and expectations define in ICH Q 10 for Management Responsibilities, Quality Risk Management, Quality Planning, Management of OutsourcedActivities and Purchased Materials (External Network) and Business Continuity Planning; and morespecifically ICH Q9 on Quality Risk Management and all broad applications and tools
  • Strategic and effective collaboration and cross-functional leadership skills to drive continuous improvement and promote knowledge sharing and endorsement of best practices across sites and functions
  • Excellent facilitation and project management skills, with strong verbal and writtencommunication skills
  • Proven track of record with data analytics, development of metrics and the and use of visualization tools to conveyperformance messaging
  • Demonstrated ability to influence areas not under direct control to achieve objectives andeffectively communicate challenging goals and objectives
  • Demonstrated ability to make and act on decisions while balancing speed, quality and risk
  • Ability to provide innovative ideas to improve quality and compliance that create value including seeking new information and external insights
  • Capable of working and communicating effectively with all levels of the organization globally
  • Proven ability to effectively initiate and drive change across our Manufacturing Divisionand global networks
  • Capable of facilitating global forums and maintaining effective Communities of Practice, Common Interest Groups and other Knowledge Management solutions
  • Proven ability to lead and implement multiple projects/tasks simultaneously with competing and/or changing priorities; effective time management
  • Ability to encourage, motivate, and guide individuals and teams in improving effectiveness, efficiency and compliance


Our Manufacturing & Supply Division is dedicated to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that's devoted to delivering a high quality, reliable supply to customers and patients on time, every time.

Who we are ...

We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

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 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.

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We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Search Firm Representatives Please Read Carefully
Merck & 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:
Regular

Relocation:
No relocation

VISA Sponsorship:
No

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:
1

Requisition ID:R114595