Associate Director, Regulatory Affairs

Merck & Co.

388d • Onsite

About The Position

The Associate Director of Regulatory Affairs will lead the Molecular lab within the Late Development Vaccines bioanalytical group at Merck Sharp & Dohme. This role involves overseeing laboratory operations, system validation, and ensuring compliance with regulatory requirements while managing a team and collaborating with various stakeholders. The position is based at a new state-of-the-art facility in West Point, PA, with initial work at the Springhouse Innovation Park facility until the new lab is fully operational.

Requirements

• B.S. Degree in Biology, Chemistry, Engineering, or related sciences with at least 8 years of industry experience.
• Strong interpersonal skills with the ability to influence and support a culture of inclusion and empowerment.
• Project management skills to plan, execute, and monitor projects to successful completion.
• Experience with validation activities and understanding of regulatory/compliance requirements.
• Experience working within a GxP laboratory, preferably in an analytical lab.
• Experience supervising or managing staff in a direct reporting relationship.
• Highly organized and capable of multitasking to manage equipment or system-related schedules and documents.
• Excellent written and verbal communication skills to articulate complex technical information to non-technical stakeholders.
• Ability to work independently and as part of a multidisciplinary team in a challenging environment.
• Analytical skills and experience in Root Cause Analysis (RCA).

Responsibilities

• Lead a team of staff across Laboratory Operations, providing supervision, mentorship, and coaching.
• Work closely with IT teams and risk/security organizations to ensure project deliverables and ongoing operations receive appropriate support.
• Support the implementation of automation solutions and develop reporting, analytics, and visualization solutions for local operations.
• Ensure automation systems are maintained in a validated state and comply with GXP requirements.
• Oversee the computer system validation process for lab equipment and manage asset management activities across vendors and facilities staff.
• Serve as a system administrator for equipment applications and assist in managing controlled temperature units.
• Partner with vendors, QA, and IT to develop best practices for maintenance and validation processes.
• Maintain a motivated mindset toward continuous improvement and utilize electronic application platforms for documentation.

Benefits

• Hybrid work model with three days on-site per week and one remote working day.
• Commitment to diversity and inclusion in the workplace.
• Opportunities for professional development and continuous improvement.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree
• Number of Employees: 1,001-5,000 employees