Director, Quality Analytical Support

Merck & Co.; West Point (PA); Hybrid; USD 173,000 - 273,000; Full time

Job summary

Merck & Co. in West Point, PA seeks a Director of Quality Analytical Support to lead a team of analytical SMEs ensuring right-first-time execution and compliance with cGMP/GLP standards. You will drive deviation management, change control, and data integrity across laboratory operations.

The role requires extensive leadership experience, deep analytical expertise across platforms, and a track record of improving production systems within a regulated pharmaceutical environment.

Qualifications

• Minimum 12 years of related industry experience.
• Minimum of 5 years of experience in a cGMP-regulated laboratory environment (Biologics, Vaccines, or Pharmaceutical industry preferred).
• Minimum of 5 years of direct supervisory or team leadership experience in a technical/Quality environment.
• Strong expertise in analytical techniques across multiple platforms (e.g. Chromatography/Separations, Biochemistry, Microbiology, and automated laboratory systems).
• Demonstrated Quality decision-making and critical thinking capabilities.
• In-depth knowledge of cGMP/GLP requirements, regulatory expectations, and compendial compliance.
• Demonstrated ability to effectively write and review technical documents.

Responsibilities

• Lead, coach, and mentor a team of analytical scientists and subject matter experts; conduct regular performance evaluations.
• Manage team capacity and demand; prioritize tasks for schedule adherence and project delivery.
• Oversee technical onboarding and ensure up-to-date training on processes, systems, and compliance.
• Utilize production systems to optimize workflows and drive continuous improvement.
• Lead and participate in tier meetings to align priorities and share best practices.
• Serve as primary contact for technical issues and escalate regulatory concerns promptly.
• Own technical change controls and document changes to methods, equipment, reagents, and key parameters.
• Guide Troubleshooting of complex analytical methods and equipment; foster cross-functional problem-solving.
• Oversee investigations; ensure robust root cause analyses and effective CAPAs.
• Ensure high-quality documentation for investigations and regulatory support.
• Support audits and regulatory inspections; lead responses and compendial assessments.
• Ensure activities comply with cGMP/GLP and regulatory requirements.
• Promote safety culture; integrate safety assessments into technical decisions.

Skills

Analytical Instrumentation

Change Control Management

Change Controls

Change Management

Chemical Analysis

Coaching Feedback

Microbiological Analysis

People Leadership

Production System

Root Cause Identification

Supervision

Talent Development

Technical Investigation

Technical Transfer

Troubleshooting

Workflow Optimization

Workload Management

Education

Bachelor's, Master's, or Ph.D. in Chemistry, Biochemistry, Microbiology, Molecular Biology

Job description

Job Description

Position Overview:

The Director, Quality Analytical Support provides operational leadership and technical oversight to a team of analytical subject matter experts (SMEs) supporting West Point laboratory operations. This team is responsible for direct shopfloor & operational support, deviation management, change control, and standards, sample, data, and inventory management.

The successful candidate will manage daily activities, foster a culture of compliance and safety, and drive continuous improvement utilizing established production systems to ensure robust, right-first-time execution and compliance with cGMP/GLP standards.

Primary Responsibilities (includes, but are not limited to)

• People Leadership: Lead, coach, and mentor a team of analytical scientists and subject matter experts. Conduct regular performance evaluations, support professional growth, and build technical capabilities within the team.
• Workload & Resource Planning: Manage team capacity and demand. Prioritize and assign tasks to ensure schedule adherence, timely technical support, and project delivery aligned with corporate objectives.
• Training & Onboarding: Oversee the technical onboarding of new team members. Ensure the team maintains up-to-date training on technical processes, laboratory systems, and compliance requirements.
• Continuous Improvement: Utilize MPS production systems to optimize workflows, eliminate waste, and drive continuous improvement.
• Tier Governance: Lead and/or participate in daily/weekly tier meetings and governance forums to communicate priorities, track team performance, share best practices, and align technical support with broader manufacturing and business needs.
• Escalation Management: Serve as the primary point of contact for technical issues, ensuring timely and effective escalation of critical technical or quality concerns to site leadership.
• Change Control Management: Author, review, and own technical change controls. Assess, implement, and document changes to analytical methods, equipment, reagents, columns, and key parameters to ensure continued suitability, compliance, and data integrity.
• Troubleshooting: Guide the team in troubleshooting complex analytical methods and laboratory equipment. Foster cross-functional problem-solving with Quality Control, Manufacturing, Quality Assurance, Engineering, and global divisional partners (e.g., Global Quality Large Molecule Analytical Sciences).
• Quality Investigations: Oversee, review, and approve complex laboratory investigations. Ensure robust root cause analyses are conducted and effective Corrective and Preventive Actions (CAPAs) are developed, implemented, and tracked.
• Documentation Standards: Ensure high-quality authorship of investigation reports, impact assessments, and associated regulatory support documentation.
• Audit & Inspection Support: Act as a key technical resource during regulatory inspections and audits. Lead responses to regulatory questions, coordinate compendial assessments, and manage global test method updates.
• Regulatory Compliance: Ensure all team activities are performed in strict accordance with cGMPs, GLPs, international regulations, company policies, and local procedures.
• Safety Culture: Act as an active advocate for maintaining a safe and healthy laboratory work environment. Ensure safety risk assessments and protocols are fully integrated into all technical decisions, methods, and laboratory support activities.

Education

• Bachelor's, Master's, or Ph.D. degree in Chemistry, Biochemistry, Microbiology, Molecular Biology, or a related scientific discipline.

Required Experience & Skills

• Minimum of 12 years of related industry experience.
• Minimum of 5 years of experience in a cGMP-regulated laboratory environment (Biologics, Vaccines, or Pharmaceutical industry preferred).
• Minimum of 5 years of direct supervisory or team leadership experience in a technical/Quality environment.
• Strong expertise in analytical techniques across multiple platforms (e.g. Chromatography/Separations, Biochemistry, Microbiology, and automated laboratory systems).
• Demonstrated Quality decision-making and critical thinking capabilities.
• In-depth knowledge of cGMP/GLP requirements, regulatory expectations, and compendial compliance.
• Demonstrated ability to effectively write and review technical documents.

Preferred Skills

• Experience with lean methodologies and production systems (MPS or equivalent), and continuous improvement frameworks.
• Demonstrated communication, conflict resolution, and cross-functional collaboration skills.

Required Skills: Analytical Instrumentation, Change Control Management, Change Controls, Change Management, Chemical Analysis, Coaching Feedback, Microbiological Analysis, People Leadership, Production System, Root Cause Identification, Supervision, Talent Development, Technical Investigation, Technical Transfer, Troubleshooting, Workflow Optimization, Workload Management

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

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

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 .

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

Employee Status:

Regular

Relocation:

No relocation

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:

10/2/2026

*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.

Requisition ID:

R417509