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Job Description

The West Point Quality organization ensures our products are manufactured, processed, tested, packaged, stored, and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements.  Partnering across our West Point campus, internal manufacturing facilities, external contract manufacturers and suppliers we create a global manufacturing network dedicated to deliver a compliant, reliable supply to customers and Patients on time, every time, across the globe. The West Point Quality organization is a team of leaders who will exemplify and cultivate the Company's core leadership behaviors and ways of working, fostering a culture of collaboration, innovation, and accountability across all levels of the organization while maintaining alignment with the company's values and strategic vision.

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 committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

The Quality Engineering Director serves as a quality leader accountable for the quality oversight of maintenance, equipment reliability, validation and engineering organizations including service providers supporting the West Point Manufacturing and Quality Control laboratories. The Director is responsible for implementing Divisional, Company and Site policy, procedures and guidelines and for discharging Quality Operations responsibilities. These activities include a broad involvement in all Quality aspects associated with the activities, including deviation management, change control, and compliance. They act as key regulatory compliance liaison to interface with regulatory agencies during inspections. They are a member of the Site Quality Leadership Team and Equipment, Maintenance and Utilities Senior Leadership Team and direct Quality activities associated with the various teams.

The incumbent will lead establishment of the organizational model for Quality Engineering and will be responsible for development of the key responsibilities, performance indicators, actions to achieve a sustainable organization design across the West Point site. The responsibilities of this role will include sustainment through continuous improvement of the organization at the site.

Primary Activities:

+ Establish and lead the Quality Engineering Department at the West Point site.

+ System owner for the Facilities, Utilities, Equipment and Manufacturing Controls QMS topic for the site. Maintains Quality Management systems and drives sustained compliance.

+ Point person for coordination and deployment of quality oversight procedures and expectations for the organization (e.g. routine maintenance and capital projects)

+ Ensuring that the Governing procedures are robust and aligned to Quality Management System and Global Procedures and the procedures enable the organization to be successful.

+ Contributes to the process for updating policies and guidelines for the West Point site and our Manufacturing Division.

+ Actively ensures multi-disciplinary teams work efficiently to drive to thorough root cause analysis and effective and timely closure of investigations. Drives efforts to reduce deviations.

+ Ensures that personnel operate within established policies/procedures of the Division and Corporation and comply with all applicable governmental regulations (GMP, EPA, etc.), both domestic and foreign.

+ Coach, teach, connect applicability and importance of quality systems/GMPs

+ Proactively partners with cross-functional groups to ensure projects are timely and robust providing quality, technical and scientific support to ensure corporate goals.

+ Management and support for Quality capital planning/management.

+ Responsible for inspection readiness and regulatory inspection support across West Point Engineering and Maintenance scope

+ Ensure that short term and long-term team objectives are established for the Quality Engineering organization and achieved while reliably supplying quality product.

+ Provide tactical and strategic direction to the Quality Engineering team including leadership influence within the cross functional team of support.

+ Promote the behaviors and principles that drive continuous improvement

+ Develop and continue to drive improvement to key performance indicators and business outcomes within the Quality Engineering organization.

+ Operates in a safe and efficient manner and in compliance with our Manufacturing Division Safety and Health Policy.

+ Financial Stewardship – Responsible for development and management of the Quality Engineering team operating budget as defined with the profit plan. Accountable for meeting the operating budget and continuously reducing cost. Ensure members of the team have high business acumen and understand how they may impact business finances.

+ People Management – Responsible for creating, hiring and sustaining a highly engaged workforce through utilization of the Company’s Enterprise Leadership Behaviors and Inclusion. Provide timely feedback and performance evaluations for direct reports after obtaining the relevant input and evaluation. Team with other members of the QLT team and/or Site Leadership team to plan and implement talent management plans for the Quality Engineering staff.

+ Stays current on emerging trends, technologies and regulatory developments.

Minimum Required Education and Experience:

+ Bachelor’s degree (BA/BS with fifteen years applied professional work experience in one of the following pharmaceutical work areas: quality assurance, compliance, manufacturing operations, technical operations **OR**

+ Master’s degree (MA/MS) with ten years applied professional work experience in one of the following pharmaceutical work areas: quality assurance, compliance, manufacturing operations, technical operations.

+ Concurrently, five (5) years of managerial experience, with responsibility for direct and indirect reports.

Required Experience, Skills, and Knowledge:

+ Applicable experience, strong understanding and knowledge of relevant quality systems expectations in the biotechnology or vaccine industry.

+ Ability to interpret and relate quality standards for implementation and review.

+ Strong working knowledge of Engineering, Maintenance, Manufacturing support systems, and associated business processes.

+ Strong operational management capabilities, adept at overseeing various operational aspects to drive efficiency and effectiveness.

+ Ability to work independently while fostering collaboration in team settings and matrix organizations to achieve common goals.

+ Highly skilled in listening to diverse perspectives, developing impactful solutions, and advocating for effective positions through influence.

+ Experience in developing and implementing comprehensive organizational change management, communication, and engagement strategies.

+ Broad understanding of organizational and business dynamics, with the ability to connect financial metrics to overall business outcomes and benefits.

+ Excellent communication, leadership, and problem-solving skills, with the ability to distill complex data and actionable insights and recommendations.

+ Very skilled at organizing complex topics, strong project management skills, able to handle multiple tasks concurrently

+ Adapts to rapidly changing business needs, fostering a flexible and responsive approach to challenges

+ Fosters positive, transparent and productive relationships across various stakeholders

+ Proven history of challenging the status quo of business standards and processes with the ability to propose solutions

+ Proven history of developing strategic plans and implementing on time

+ Ability to be decisive and influence management with demonstrated leadership skills and management of large teams.

+ Experience in managing cross-functional initiatives or programs

+ Understanding and experience in various business methodologies (ex. Lean thinking, Agile methodology, Design thinking, Six sigma, etc.)

Preferred Experience and Skills:

+ Preferred experience in quality organizations and/or manufacturing operations, with a solid understanding of industry practices

+ Familiarity with plant audits and supplier audits, showcasing an awareness of compliance and quality assurance processes.

+ Strong sense of accountability, with a proven ability to drive results and learn from past experiences to inform future actions.

+ Demonstrates sound judgment in gathering and analyzing pertinent data to make independent, timely decisions.

+ Skilled in communicating effectively, influencing stakeholders, and appropriately escalating issues and decisions when necessary.

+ Incumbent with facilities and engineering support experience advantageous

Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)

Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)

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 (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088\_EEOC\_KnowYourRights\_10\_20.pdf)

EEOC GINA Supplement​

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/)

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

**San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

**Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

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:

Domestic

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

05/14/2025

*A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.

**Requisition ID:** R327789