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 our 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.

The Director, Quality E2E Leader reports to the AVP, West Point Quality Operations, and is responsible for implementing Divisional, Company and Site policy, procedures and guidelines and for discharging Quality Operations responsibilities within the E2E. These activities include a broad involvement in all Quality aspects associated with the manufacturing activities within the E2E, including product release, deviation management, environmental monitoring, and compliance. They act as key regulatory compliance liaison to interface with regulatory agencies during inspections on behalf of the E2E. They are a member of the Site Quality Leadership Team and E2E Senior Leadership Team and direct Quality activities associated with the various Integrated Product Teams (IPTs) within the E2E.

Responsibilities

• Directly supervises the activities of IPT Quality Leaders and associated support staff.

• Responsible for hiring and training employees, administering all personnel policies and development programs, and placing an emphasis on Talent Management.

• Primary contact for Quality Operations within the E2E.

• Familiar with all regulations and compendia (domestic and foreign) and automation disciplines associated with operations within the E2E.

• Maintains Quality Management systems and drives sustained compliance within the E2E.

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

• Ensures adherence to site compliance requirements and Quality Systems, while optimizing Quality activities within the E2E.

• Proactively partners with Operations and Technology groups to ensure all technology transfers and new product introductions are timely and robust providing technical and scientific support to ensure corporate goals.

• Actively ensures multi-disciplinary teams work efficiently to drive to thorough root cause analysis and effective and timely closure of investigations. Drives E2E efforts to reduce deviations.

• Plans, directs, and coordinates all Quality Operations activities within the E2E to ensure production plans are met.

• Ensures that the E2E Quality Operations 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.

• Oversees the disposition decision for all products to ensure that they are produced in conformance to all applicable policies/procedures of our Company and in compliance with cGMPs and all governing regulations.

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

• Actively builds succession planning for all levels of Quality within the E2E. Critically evaluates organizational effectiveness and design of Quality within the E2E.

• Represents the E2E on key governance committees including West Point Operations Review and relevant Fact Finding Committees.

• Approves interim investigations, expanded change requests, and significant deviations etc. on behalf of the E2E.

• Ensure that short term and long-term team objectives are established with milestones.

• Provide tactical and strategic direction to the E2E team including leadership influence within the cross functional and global 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.

• Responsible for development and management of the E2E 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.

• Responsible for creating, hiring, and sustaining a highly engaged workforce through utilization of our Company 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.

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

Minimum Required Education and Experience:

• Bachelor’s degree (BA/BS) with fifteen (15) 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 (10) years applied professional work experience in one of the following pharmaceutical work areas: quality assurance, compliance, manufacturing operations, technical operations.

Required Experience, Skills, and Knowledge:

• Five (5) years of managerial experience, with responsibility for direct and indirect reports.

• Demonstrated understanding of quality systems, including a strong grasp of current Good Manufacturing Practices (cGMPs) and regulatory standards, with a compliance-oriented mindset

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

• Proven track record of successfully delivering strategic projects and establishing or redesigning organizational structures.

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

• Exceptional analytical and problem-solving skills, with the ability to distill complex data into actionable insights and recommendations.

• 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.

• Demonstrated decisiveness and the ability to influence management positively, showing proven leadership skills in managing large teams.

• 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.

• Strong project management skills, capable of organizing complex topics and managing multiple tasks simultaneously in a dynamic environment.

• Quick to adapt to rapidly changing business needs, fostering a flexible and responsive approach to challenges.

• Ability to cultivate positive, transparent, and productive relationships across various stakeholders.

• A team player with high initiative, demonstrated planning skills, proven performance in problem-solving, team building and staff development.

• Proven history of challenging existing business standards and processes, demonstrating an ability to propose innovative solutions.

• Established history of developing and executing strategic plans within set timelines

• Experience in managing cross-functional initiatives and programs, facilitating collaboration across diverse teams.

• Understanding and practical experience with various business methodologies (e.g., Lean Thinking, Agile, Design Thinking, Six Sigma) to drive process improvements.

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.

Current Employees apply HERE

Current Contingent Workers apply HERE

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.

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

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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

U.S. Hybrid Work Model

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:

Hybrid

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

04/18/2025

*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.