Director, Data Integrity - Job Opportunity at MSD

Location: West Point, Pennsylvania, USA

Company: Merck & Co., Inc. (also known as Merck Sharp & Dohme LLC)

Job Description

The Director, Data Integrity (DI) is responsible for overseeing and ensuring the integrity, accuracy, and compliance of data generated within our manufacturing and laboratory processes. This role will support the site's data integrity strategy and compliance with Manufacturing Division DI requirements. The incumbent will also develop a 3-year site plan, key performance indicators, communication plan, and training content for all employees and contractors at the West Point site.

Key Responsibilities

• System owner for data governance and CGMP/CGDP documentation QMS topic.
• Primary SME for site/function for DI-related questions and support.
• Support development and implementation of DI Global Procedures (GPs).
• Coordinate and deploy global DI procedures within the site/functional area.
• Manage ongoing DI GEMBA program across the site/functional area.
• Ensure data management systems meet regulatory requirements and industry standards.
• Champion the DI mindset and culture on site through a developed program and delivery plan.
• Develop and deliver training programs on data integrity principles, best practices, and regulatory requirements.
• Ensure DI governance process is visible from operational areas to Leadership Teams.
• Develop and distribute DI materials and information across the site/network.
• Maintain inspection readiness and provide inspection responses.
• Conduct regular reviews and assessments of data integrity risks and implement CAPA as needed.
• Act as a single point of contact for Quality Risk Management related to data governance and GMP records.
• Serve as SME on data integrity matters and provide guidance.
• Lead efforts to monitor and audit data processes to ensure compliance with regulatory requirements (e.g., FDA, EMA, ICH).
• Drive continuous improvement initiatives to enhance data management processes, systems, and capabilities.
• Stay current on trends, technologies, and regulatory developments related to data integrity.

Minimum Required Education and Experience

• Bachelor’s degree (BA/BS) with 8 years of relevant professional experience, or Master’s degree (MA/MS) with 6 years of relevant professional experience in data management, quality assurance, compliance, manufacturing operations, technical operations, or IT.

Required Experience, Skills, and Knowledge

• Strong understanding and knowledge of Data Integrity expectations in the biotechnology or vaccine industry.
• Proven success in delivering strategic data integrity projects.
• In-depth knowledge of regulatory requirements and guidelines related to data integrity (e.g., 21 CFR Part 11, Annex 11).
• Experience with data management systems and software tools (e.g., LIMS, ELN).
• Strong working knowledge of laboratory, manufacturing, and support systems.
• Excellent communication, leadership, and problem-solving skills.
• Ability to manage multiple tasks concurrently and organize complex topics.
• Strong project management skills.
• Ability to distill large quantities of data into simple messages and provide recommendations.
• Experience in managing cross-functional initiatives or programs.
• Understanding and experience in business methodologies (e.g., Lean thinking, Agile, Six Sigma).

Preferred Experience and Skills

• Experience in a Quality organization (quality systems) and/or Manufacturing operations (Automation).

Important Notices for Internal Applicants

• Employees must have at least 12 months of service in their current position before applying for open positions.
• If offered a position within the same salary and geographical parameters before reaching your separation date, you are no longer eligible for separation benefits.
• Compliance with vaccination policies may be required by external stakeholders.

Commitment to Inclusion

We are an Equal Opportunity Employer committed to fostering