Director, Quality Analytical Support

Merck • Upper Gwynedd Township, PA

13d • $173,200 - $272,600 • Hybrid

About The Position

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.

Requirements

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

Nice To Haves

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

Responsibilities

• 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.
• Manage team capacity and demand. Prioritize and assign tasks to ensure schedule adherence, timely technical support, and project delivery aligned with corporate objectives.
• Oversee the technical onboarding of new team members. Ensure the team maintains up-to-date training on technical processes, laboratory systems, and compliance requirements.
• Utilize MPS production systems to optimize workflows, eliminate waste, and drive continuous improvement.
• 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.
• Serve as the primary point of contact for technical issues, ensuring timely and effective escalation of critical technical or quality concerns to site leadership.
• 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.
• 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).
• 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.
• Ensure high-quality authorship of investigation reports, impact assessments, and associated regulatory support documentation.
• 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.
• Ensure all team activities are performed in strict accordance with cGMPs, GLPs, international regulations, company policies, and local procedures.
• 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.

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree