Director, Quality Control

Job Description

Overview

The Director, Biologic Critical Reagents is a senior scientific leader responsible for the strategy, sourcing, development, quality, and lifecycle management of critical biological reagents used across discovery, development, analytical testing, manufacturing, and quality. This role ensures reagent reliability, traceability, and regulatory compliance while driving innovation through robust platforms, process excellence, and strategic partnerships. The Director will lead a multidisciplinary, global team (including first-line managers and scientists) and collaborate extensively across inline and pipeline large molecule product initiatives.  

Key Responsibilities

Reagent Strategy, Governance & Lifecycle Management

• Define and execute a global strategy for biologic critical reagents (e.g., reference standards, controls, cell banks, antibodies, viral stocks, enzymes, media, assay reagents) across the Large Molecule product lifecycle.

• Establish governance, policies, and procedures for reagent selection, qualification, characterization, release, change control, storage, distribution, and disposal.

• Drive reagent lifecycle management, including change control, comparability assessments, requalification, and retirement.

• Implement risk assessment, criticality scoring, and business continuity planning to mitigate reagent supply risk.

• Lead a team responsible for qualification of cell banks, reference materials, in-house standards, and assay controls.

• Ensure reagent quality and fitness-for-purpose through adherence to acceptance criteria, stability programs, compliance standards, and ongoing monitoring (i.e., required qualification and re-certification testing).

• Partner with subject matter experts in large molecule critical reagent management to ensure method development, remediation, validation, and lifecycle support for inline and pipeline reagents are taken up and supported in LM BCR.   

• Oversee the on-time supply of critical reagents to support end-to-end analytical technology transfer, including local batch release, registration, and testing on importation method siting decisions.

Cross-Functional Collaboration & Vendor Management

• Partner with R&D, Analytical Development, Manufacturing, Quality, Regulatory, Clinical, and Supply Chain to meet functional and regulatory requirements for nonclinical, clinical, and commercial critical reagent activities.

• Oversee vendor selection, qualification, contracting, and performance management for external suppliers and CMOs as per quality standards.  

• Implement and maintain documentation and data management systems (e.g., LIMS or equivalent) to ensure traceability and compliance with ALCOA+ principles.

Quality, Compliance & Data Integrity

• Ensure strong GMP/GxP compliance and data integrity across reagent-related activities; serve as a quality and data integrity champion.

• Author and implement global SOPs, drive SOP harmonization, and standardize training and second-scientist review practices across departments.

• Lead investigations and root cause analyses for reagent-related failures or supply issues; implement robust corrective and preventive actions.

Leadership, Operations & Continuous Improvement

• Build, mentor, and lead a high-performing, cross-functional team; develop talent and succession plans.

• Lead global cross-functional teams and first-line managers; facilitate leadership team meetings, town halls, and cross-department forums.

• Drive portfolio and resource prioritization, headcount planning and approvals, cost-saving insourcing initiatives, and serve as lab/facility liaison across multiple sites.

• Champion MPS, Lean/5S, workflow and capacity optimization, Gemba activities, consumables management, and continuous improvement of LM BCR analytical operations.

• Manage local BCR Sciences budget, capital investments, and vendor spend; present strategy, metrics, and status to site and global leadership.

• Significant experience in Microsoft Office (including advanced Excel and VBA), DOE and statistical analysis (e.g., JMP).

Education Requirements:

• Bachelor’s degree in Molecular Biology, Immunology, Biochemistry, Cell Biology, Virology, or related field.

• Advanced degree (MS or PhD) in Molecular Biology, Immunology, Biochemistry, Cell Biology, Virology, or related field preferred.

Required Experience and Skills:

• 10+ years of experience in large molecule (biologics/vaccines) development, engineering, analytical sciences, or reagent development in relevant industries, including 4+ years in leadership roles.

• Technical knowledge of biologic reagents and analytical methods (e.g., ELISA, SPR/BLI, SDS-PAGE, SEC, HPLC, qPCR, sequencing, cell-based assays).

• Strong understanding of GMP/GxP requirements for large molecule commercial reagents as per global agency (e.g., FDA, EMA, and ICH) expectations for reference standards and analytical reagents.

• Demonstrated experience in supplier qualification, contract negotiation, and external partnership management.

• Experience with LIMS, inventory/reagent management, ELN, and electronic documentation and training/compliance systems.

• Excellent leadership, communication, and stakeholder-management skills, with a track record of leading complex investigations and driving corrective and preventive actions.

Preferred Qualifications

• Experience with monoclonal antibodies, recombinant proteins, cell and gene therapies, or vaccines.

• Prior experience in a global, multi-site environment and with international regulatory interactions.

• Training or certifications in project management, quality systems, or risk management (e.g., PMP, Six Sigma, CQE).

Leadership Competencies

• Strategic mindset and ability to translate scientific and business needs into effective reagent strategies.

• Strong focus on quality, data integrity, and regulatory compliance.

• Collaborative influencer with strong relationship-building skills across functions and geographies.

• Change leader who drives modernization, standardization, and continuous improvement.

• Talent developer who fosters learning, mentorship, and robust succession planning.

Working Conditions & Travel

• Hybrid leadership role with frequent interaction among direct staff as well as enabling laboratories and manufacturing areas. May require flexible hours to support critical activities and investigations.

• Travel up to 5% to other company sites, suppliers, or external partners.

Required Skills:

Analytical Instrumentation, Biological Analysis, Coaching Feedback, Communication, Driving Continuous Improvement, Key Client Relationships, Leadership, Management Process, Microbiological Analysis, Organizational Planning, People Leadership, Qualitative Testing, Quality Improvement Programs, Quantitative Assay, Talent Development, Technical Transfer

Preferred Skills:

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:

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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”.

The salary range for this role is

$173,200.00 - $272,600.00

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:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

03/27/2026

*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.