Associate Director, Data Integrity Job Offer

Company Name: MSD

Job Title: Associate Director, Data Integrity

Job Description

The Data Integrity (DI) Champion oversees the management strategy and implementation of Manufacturing Division DI requirements at our site. Key responsibilities include leading and facilitating the DI Quality Management System and promoting a healthy Data Integrity Culture through training, communication, and oversight.

Primary Activities

• System owner for Data Governance and CGMP/CGDP Documentation QMS, acting as the primary point of contact for the DI COE.
• Primary SME for site/function DI-related queries and support.
• Support development and execution of DI Global Procedures, including workshops, document reviews, pilots, deployment, and implementation.
• Coordinate and deploy global procedures within the site/functional area.
• Implement ongoing DI GEMBA program within the site/functional area.
• Ensure new systems/processes/procedures are DI compliant in collaboration with lab, IT, SF automation partners, and QA IT.
• Track DI remediation progress in conjunction with IT, Operations, and Quality site capital program leads for reporting through Ops, Quality, and QMS tiers.
• Champion the DI mindset and culture onsite and influence employees.
• Ensure Site DI governance process visibility from operational areas to Leadership Teams.
• Actively participate in the DI Knowledge Management Forum / Community of Practice.
• Distribute DI information within the site and to the DI COE.
• Support the site for DI Inspection Readiness / Inspection Responses for DI.
• Integrate Quality Risk Management as it relates to data governance and GMP records.
• Assist with site investigations related to Data Integrity as needed.
• Present DI compliance metrics, obstacles, and challenges to site management.
• Review the DI topic at the Site Quality Council Meeting per the QC standard.
• Participate in external DI forums as required.

Minimum Required Education and Experience

• Bachelor’s degree (BA/BS) with 8 years of applied professional work experience in pharmaceutical work areas such as quality operations, compliance, manufacturing operations, technical operations, or IT.
• Master’s degree (MA/MS) with 6 years of applied professional work experience in the aforementioned pharmaceutical work areas.

Required Experience, Skills, and Knowledge

• Strong understanding of Data Integrity Expectations and experience delivering strategic data integrity projects.
• Knowledge of computerized systems / IT, including SDLC.
• Working knowledge of laboratory, manufacturing, and support systems, and associated business processes.
• Demonstrated leadership skills.
• Excellent written and oral communication and presentation skills.
• Strong project management skills and ability to handle multiple tasks concurrently.
• Ability to distill large quantities of data into simple messages and provide recommendations.
• Adaptability to rapidly changing business needs.
• Foster positive, transparent, and productive relationships.
• Proactive self-starter with initiative to solve difficult problems creatively.
• History of challenging the business status quo and proposing solutions.
• Experience in developing and implementing strategic plans on time.
• Proficiency in organizational change management, communication, and engagement strategies.
• Ability to be decisive and influence management with demonstrated leadership skills.
• Experience in managing cross-functional initiatives or programs.
• Broad organizational and business acumen with the ability to link finances to business outcomes.
• Understanding of various business methodologies (e.g., Lean thinking, Agile methodology, Design thinking, Six Sigma).

Preferred Experience and Skills

• Experience in a Quality organization and/or Manufacturing operations preferred.

Notice for Internal Applicants

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees governed by this policy must have a minimum of 12 months in their current position before applying for open positions.

If offered a separation benefits package but have