Job Description

The Global Quality Group within the Manufacturing Division is seeking an experienced Leader to provide strategic oversight and direction for a complex, enterprise-level transformation program. This project aims to transform QC testing to support our pipeline and in-line supply products. The project has significant innovation components including end-to-end analytical digitization, analytical instrumentation innovation, lab automation, standardized laboratory workflows, and a digitized QMS and lab operations system.

The Quality Lead, in collaboration with the project leadership team, will oversee integrated planning, governance, and execution across a highly matrixed project, ensuring alignment to GxP requirements while incorporating novel technical and digital laboratory components and delivery of key program outcomes. They will partner with executive leadership, business stakeholders, cross-functional teams and external partners, as necessary, to manage interdependencies, support timely decision-making, and advance the program from project planning to regulatory filing and approval and through operational transition and sustainment. They will be a key input to an integrated plan that includes Technology Development, Analytical Development, Quality and Compliance, Regulatory, IT and external partners all collaborating seamlessly to deliver a scalable, compliant, and future-ready model, all within an aggressive timeline.

Key Responsibilities and Requirements

The ideal candidate can meld strong technical skills and an innovation mindset to set strategic Quality direction and compliantly translate it into an integrated, end-to-end program plan while managing and executing that plan across milestones, dependencies, and the critical path. This role is responsible for directing decision forums that enable alignment and remove barriers, while proactively managing risks, assumptions, constraints, and interdependencies across highly matrixed, cross-functional teams. Acting as the connective link between executive sponsors and delivery teams, the candidate provides clear, data-driven insights and recommendations, drives technology and operating model transformation, and ensures alignment with quality and regulatory requirements. Success in this role requires a structured, analytical leader with strong stakeholder and communication skills, an innovation mindset, a focus on measurable value realization, and the ability to enable adoption and transition outcomes into sustainable operations. A strong background in analytical development, analytical testing and automation validation within a GMP laboratory is expected. The role will also need to have expert level leadership to supervise Quality and other personnel in direct support of the cross-functional program goals.

Required Experience

· Bachelor’s degree required; advanced degree (PhD, MBA, PharmD, or equivalent) strongly preferred with

· 15+ years of relevant experience in quality, pharmaceutical development, manufacturing and science technical operations, or related biopharmaceutical functions.

· Leadership experience with CGMP testing laboratories subject to FDA inspections.

· Demonstrated experience utilizing an innovative mindset to challenge the status quo and improve workflows.

· Experience in development and implementation of laboratory technology.

· Experience in GxP, quality, and compliance-driven management programs.

· Strong program governance, structured execution, and analytical skills.

· Excellent communication, stakeholder management, and executive presentation skills.

· Proven experience leading enterprise-level technology transformation or lab innovation programs

· Ability to manage multiple priorities and complex interdependencies effectively.

· Strong understanding of regulated, scientific, technical, or IT/program environments.

· Financial acumen, including budgeting, forecasting, and value tracking.

· Proven ability to build alignment across internal and external cross-functional teams.

Preferred Experience

· Programming experience will be an asset.

· Experience in research and development within the pharmaceutical industry and in clinical phase Quality expectations.

· Experience supporting workforce strategy, technology evaluation, or enterprise transition initiatives.

· Experience working directly with third party technology providers.

· Experience with filing and registering new products.

· Experience with stage gate or capital governance models.

Required Skills:

Ability to Coordinate, Ability to Coordinate, Analytical Thinking, Aseptic Manufacturing, Competency Management, Conflict Resolution, Cross-Cultural Awareness, Cross-Functional Project Management, Customer-Focused, Detail-Oriented, Driving Continuous Improvement, Financial Acumen, Innovation Management, Leadership Project Management, Legal Compliance, Microbiology, Organizational Change Management, People Leadership, Performance Plans, Process Alignment, Process Innovation, Product Lining, Project Integration, Project Management Leadership, Project Planning {+ 9 more}

Preferred Skills:

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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:

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The salary range for this role is

$210,400.00 - $331,100.00

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

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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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

10/5/2026

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