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 Quality Management Systems Director 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

Strategic Summary

the Quality Management Systems Director will drive a critical effort to create a simplified, integrated, user-centric global Quality Management System (QMS) for our human health products, with an objective to enable consistently compliant product quality, continuous improvement and effective life-cycle management.

The Quality Management Systems Director for the Training and Qualification topic, is responsible for providing leadership and direction for the development and life cycle management of processes, procedures, systems, and corresponding controlled documentation (as specified within QMS Chapter 1 – Quality Management Systems Operations) related to the Training and Qualification topic. The successful candidate will ensure their QMS is well defined per industry standards, there is a robust management system in place to monitor the health of the Training and Qualification system, and that any gaps are identified and managed to closure, specifically:

• Processes are defined with adequate Procedures, Governance, and clear Roles, Responsibilities and Accountabilities

• Organization and Infrastructure to support the execution of the processes are defined and installed

• Metrics are developed for the ongoing evaluation that the system is working as intended, reviewed by the appropriate levels of management, and used as a basis for continual improvement

Key Functions

• Work independently and as a Team member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect | Inclusion

• Identify the regulatory requirements and define the strategy for global procedures for their topic and drive harmonization of processes and systems across the network

• Lead cross-functional teams in the design, development, and implementation of their topic within the Quality Systems and Compliance chapter (QMS Chapter 3)

• Interface with other QMS Chapter and Topic Owners to ensure seamless linkages with their systems, as required, and provide ample opportunities and forums to interact with relevant user communities and stakeholders

• 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 as it relates to their topic

• Provide leadership and technical direction on regulatory requirements for the above in the GMP/GDP environment

• Monitor global regulations of major markets and assess any impact on their topic in alignment with QMS policies and procedures

• Help identify, resolve/mitigate or appropriately escalate any issues or delays in topic development, adoption, or enhancement

• Serve as business owner for IT platforms that enable the execution of their topic by fully participating in the identification, testing, and approval of IT solutions and enhancements

• Drive the realization of permanent inspection readiness for their topic across the network

• Partner with Global Learning and Development to ensure their understanding of the topic requirements in support of their responsibility to develop the content of any cGMP/cGDP training assets

• Actively participate in pharmaceutical industry meetings/regulatory symposia etc., to 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

Education

• Bachelor degree in Life Sciences, Engineering or related relevant discipline

Required

• Ten years’ in the FDA and/or EU regulated pharmaceutical environment; preferably in a manufacturing site in leading manufacturing and/or quality roles and/or in Global Quality

• Demonstrated leadership in Quality & Compliance discipline and in-depth knowledge of global health authority regulations and requirements and the ability to effectively translate and communicate these requirements

• Subject matter expertise in regulatory requirements and expectations defined in ICH Q 10 for Pharmaceutical Quality Systems

• Strong collaboration and cross-functional leadership skills to drive continuous improvement and promote knowledge sharing and endorsement of best practices across sites and functions

• Effective facilitation and project management skills with strong verbal and written communication skills

• Proven ability to lead and implement multiple projects/tasks simultaneously with competing and/or changing priorities, effective time management

• Demonstrated ability to influence areas not under direct control to achieve objectives and effectively communicate challenging goals and objectives

• Demonstrated ability to make and act on decisions while balancing speed, quality and risk

• 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 the Manufacturing Division network

• Capable of facilitating global forums and maintaining effective Communities of Practice, Common Interest Groups and other Knowledge Management solutions

• Data analytics, development and use of visualization tools to convey performance messaging

Preferred

• Vaccines, biologics, devices and API regulations

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 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., Rahway, 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 …

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

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.

New hires in office-based roles in the US & Puerto Rico will be required, subject to applicable law, to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption to this vaccination requirement that can be accommodated without an undue burden to the operation. However, subject to applicable law, employees working in roles that the Company determines require routine collaboration with external stakeholders, such as employees in health services, customer facing commercial, or research based roles, will be required to be fully vaccinated as a condition of employment.

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

Pay Transparency Nondiscrimination

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.

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Search Firm Representatives Please Read Carefully
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:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Flex Time

Shift:

1st - Day

Valid Driving License:

Hazardous Material(s):

No

Number of Openings:

1

Requisition ID:R198863