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Job Description

The Associate Director of Laboratory Quality Assurance within the Quality Assurance Center of Excellence is responsible for providing Quality direction and oversight to West Point (WP) Laboratory Operations in the management of those areas assigned, such as Internal Auditing, Training, Change Control, Inspection Management, Deviation Management and Risk Management, in order to maintain compliance with Regulatory requirements. The individual is an Advocate for the development, execution and deployment of WP Site and our Company Manufacturing Division priorities. The Associate Director drives quality improvement activities and ensures alignment across Laboratory Operations in the execution of their assigned areas. The individual is responsible for the development and maintenance of Quality Systems in Laboratory Operations in accordance with current Good Manufacturing Practices (cGMPs), Good Laboratory Practice (GLPs), international regulations and our Company guidelines, policies and procedures.

The Associate Director will lead key compliance projects for Laboratory Operations aimed at elevating the compliance posture. As a Project Manager, the individual is expected to fully manage all aspects of assigned projects, including but not limited to: quality decision making, stakeholder management, issue identification and resolution, and driving all aspects of the project in alignment with established timelines.

Primary Responsibilities

+ Maintains strong quality management systems to actively ensure compliance while striving to optimize Quality Operations within the Laboratory.

+ Actively participates in the Tier process, as appropriate, and uses this forum to escalate concerns and best practices.

+ Serves as an Ad Hoc member of WP Site Quality Council.

+ Responsible for the Quality oversight and classification / approval of investigative events in Laboratory Operations by: 1) Providing guidance to Senior Quality Specialists performing reviews/approvals of investigative events; and 2) Determining the effects on test result validity, for laboratory investigative events, to ensure final reportable values are representative of the product’s quality.

+ Provides input on recommended Corrective Action and Preventive Action (CAPAs), as appropriate

+ investigative Quality Notification (iQN) approvals & assessment

+ Performs review and approval for CAPAs, Quality Compliance Tracking System (QCTS) commitments, change requests, investigative protocols and final reports.

+ Performs review and approval of Installation Qualification/Operation Qualification/Process Qualification (IQ/OQ/PQ) documents for assigned laboratories of responsibility, as needed.

+ Reviews and approves Standard Operating Procedures (SOP), Controlled Job Aides (CJA), Control Procedures, Quality Standards, etc.

+ Provides coaching and guidance to new personnel and to Quality Specialists and Sr. Quality Specialist colleagues.

+ Provides support to Regulatory Agency inspections as needed.

+ Proactively partners with Laboratory Operations and Laboratory Technology personnel to ensure that all process improvements and capital projects are timely, robust and in alignment with corporate goals.

Education Minimum Requirements

+ At least a Bachelor's degree in life science, scientific discipline or engineering area of study.

Required Experience and Skills

+ For candidates with a Bachelor’s degree, a minimum of five years of experience in GMP Manufacturing environment, Pharmaceutical/Biological Quality, Operational, Technical or Regulatory function supporting manufacturing or testing operations, or related industry experience in a laboratory, manufacturing, science related or regulated setting.

+ For candidates with a Master’s degree, a minimum of three years of experience in GMP Manufacturing environment, Pharmaceutical/Biological Quality, Operational, Technical or Regulatory function supporting manufacturing or testing operations, or related industry experience in a laboratory, manufacturing, science related or regulated setting.

Preferred Experience and Skills

+ Progressive and demonstrated Quality decision making responsibility

+ Project Management, Change Execution Management and Team Leadership experience in a Quality function.

+ Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills and ability to work in a team environment.

+ Demonstrated self-starter with capability to develop innovative solutions to challenges.

+ Demonstrated facilitative leadership skills and able to lead cross-functional project teams to deliver results.

+ Proven analytical aptitude, critical thinking skills and ability to apply key concepts.

+ Speaks with courage and candor.

+ Strong written and verbal communication skills.

+ In-depth working knowledge and application of GMPs/GLPs.

+ Proven ability to manage multiple projects simultaneously.

+ Pharmaceutical laboratory operations or related environment.

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”.

The salary range for this role is

$139,600.00 - $219,700.00

This 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:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Required Skills:

Adaptability, Adaptability, Animal Vaccination, Change Management, Cross-Cultural Awareness, Cross-Functional Teamwork, Facilitative Leadership, GLP Regulations, GMP Compliance, GMP Training, Good Distribution Practice (GDP), Good Laboratory Practices (GLPs), Inspection Readiness, IS Audit, Life Science, Management Process, Manufacturing Quality Control, Product Quality Assurance, Product Risk Management, Quality Assurance (QA), Quality Auditing, Quality Management, Quality Management Standards, Quality Metrics, Quality Systems Compliance {+ 4 more}

Preferred Skills:

Job Posting End Date:

07/30/2025

*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:** R357374