Director, Inspection-Ready Quality & Regulatory Compliance

Merck & Co.; West Point (PA); On-site; USD 142,000 - 224,000; Full time

Benefits offered by this job

Medical, dental, vision

401(k) retirement plan

Paid holidays

Sick leave

Job summary

Merck & Co. seeks an Associate Director, Inspections to lead regulatory inspections readiness and Health Authority reporting for West Point Manufacturing and Quality Control laboratories. You will drive compliance programs, monitor regulatory changes, and coordinate inspections with a matrix team across Operations, Regulatory, and Tech.

A strong leadership track record is essential. You will oversee a team of compliance professionals, ensure alignment with 21 CFR Part 11 and Annex 11, and

Qualifications

• Applicable experience, strong understanding and knowledge of relevant quality systems expectations in the biotechnology or vaccine industry.
• Expert knowledge of cGMP relevant to the biotechnology or vaccine industry including knowledge of the local and international GMP regulations.
• In-depth knowledge of regulatory requirements and guidelines (e.g. 21 CFR part 11, Annex 11).
• Ability to work independently while fostering collaboration in team settings and matrix organizations to achieve common goals.
• Highly skilled in listening to diverse perspectives, developing impactful solutions, and advocating for effective positions through influence.
• Strong working knowledge of Quality Management Systems, and associated business processes.
• Excellent communication, leadership, technical writing and problem-solving skills
• Ability to cultivate positive, transparent, and productive relationships across various stakeholders.
• A team player with high initiative, demonstrated planning skills, proven performance in problem-solving, team building and staff development.
• Experience in working with cross functional teams as well as good leadership skills in a matrix organization
• Experience in managing cross-functional initiatives or programs

Responsibilities

• Develop and implement comprehensive compliance program for the site to ensure Permanent Inspection Readiness (PIR), which includes Health Authority Reporting and inspection readiness team.
• Track and Interpret changes in regulations, industry standards and ensure proactive awareness and PIR at the site.
• Conduct regular compliance risk assessments, identify potential risks and develop strategies to mitigate the risks. Identify and address compliance issues, develop corrective action plans and implement improvements to compliance programs
• Act as a liaison and/or SME to present operational compliance to Health Authorities and regulatory agencies on relevant topics.
• Lead a team of professionals who serve as contact for regulatory agencies during inspections, responding to inspectional or regulatory agency inquiries, providing information and addressing compliance concerns.
• Serve as Manager to the lead for the team coordinating Health Authority reporting, Market action events, and complaint process management for the site.
• Provide training and guidance to employees on compliance related matters, ensuring a robust PIR at the site.
• Provide expertise in developing strategies for inspection readiness including working with Regulatory with relevant submissions for new product launches
• Skills in engaging and collaborating with various functional teams (e.g., Operations, Technology, Automation, Regulatory, Research).
• Ability to build relationships and work effectively in a team-oriented environment.
• Engage and drive continuous improvement initiatives across the site to drive simplification and standardization.

Skills

Change Management

CSV (Computer System Validation)

Decision Making

Driving Continuous Improvement

GMP Laboratory

People Leadership

Performance Qualification (PQ)

Quality Auditing

Quality Control Documentation

Quality Management Standards

Quality Management Systems (QMS)

Quality Risk Management

Regulatory Compliance

Supplier Quality Management

Training and Development

Education

Bachelor's degree

Master's degree

Job description

Merck & Co. seeks an Associate Director, Inspections to lead regulatory inspections readiness and Health Authority reporting for West Point Manufacturing and Quality Control laboratories. You will drive compliance programs, monitor regulatory changes, and coordinate inspections with a matrix team across Operations, Regulatory, and Tech.

A strong leadership track record is essential. You will oversee a team of compliance professionals, ensure alignment with 21 CFR Part 11 and Annex 11, and