Assoc. Dir., Quality Engineering
Merck
Job Description
Position Overview
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 exemplify and cultivate our company's enterprise leadership skills 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 Quality Engineering Associate Director serves as a quality leader accountable for the quality oversight of maintenance, equipment reliability, validation and engineering organizations including service providers supporting West Point Manufacturing and Quality Control laboratories. The Associate Director is responsible for implementing Divisional, Company and Site policy, procedures and guidelines and for discharging Quality Operations responsibilities. These activities include involvement in all Quality aspects associated with 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 Engineering, Maintenance and Utilities (EMU) Leadership Team and direct Quality activities associated with the team.
Reporting to the Core Site Service E2E Quality Director, the incumbent will lead establishment of the organizational model for Quality Engineering and will be responsible for development of the key responsibilities, performance indicators, and actions to achieve a sustainable organization design across the West Point site.
Essential Functions and Responsibilities (Includes, but are not limited to)
The Associate Director, Quality Engineering Lead, is responsible for:
Establishing and leading the Quality Engineering Group at the West Point site.
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Site Topic Lead 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.
Provide Quality review and approval of EMU Standard Operating Procedures.
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.
Management and support for Quality capital planning/management.
Responsible for inspection readiness and regulatory inspection support across West Point Engineering, Maintenance and Utilities scope.
Ensure that short term and long-term team objectives are established for the Quality Engineering team 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 team.
Operates in a safe and efficient manner and in compliance with our Manufacturing Division Safety and Health Policy.
People Management – Responsible for creating, hiring and sustaining a highly engaged workforce through utilization of our company's Enterprise Leadership Behaviors and Inclusion. Provide timely feedback and performance evaluations for direct reports after obtaining the relevant input and evaluation.
Stays current on emerging trends, technologies and regulatory developments.
Qualification and Skills Requirements (Includes but are not limited to)
Minimum Education Requirements and Experience:
Bachelor's Degree in Science, Engineering, or another technical field with seven (7) years’ experience in a functional area, such as Operations, Quality, Technical Operations, Technology, Engineering, Maintenance, and/or Supply Chain OR
Master’s Degree in Science, Engineering, or another technical field with four (4) years’ experience in a functional area, such as Operations, Quality, Technical Operations, Technology, Engineering, Maintenance, and/or Supply Chain
Required Experience and Skills:
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.
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
Understanding and experience in various business methodologies (ex. Lean thinking, Agile methodology, Design thinking, Six sigma, etc.)
Preferred Experience and Skills:
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:
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.
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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”.
The salary range for this role is
$126,500.00 - $199,100.00This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.
You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
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:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
10%Flexible Work Arrangements:
Not ApplicableShift:
1st - DayValid Driving License:
NoHazardous Material(s):
n/aRequired Skills:
Achieving Objectives, Adaptability, Agile Methodology, Business Process Management (BPM), CAPA Management, cGMP Regulations, Compliance Analysis, Continual Improvement Process, Corrective Action Management, Deviation Management, People Management, Quality Assurance (QA), Quality Control Management, Quality Engineering, Quality Manuals, Quality Operations, Quality Risk Management, Quality Standards, Strategic Thinking, Team ManagementPreferred Skills:
Regulatory ManagementJob Posting End Date:
07/11/2025*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:R356067