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Merck · 2 days ago
Director, Data Integrity
West Point, PA
Full-time
Hybrid
Director
8+ years exp
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Responsibilities
System owner for the data governance and CGMP/CGDP documentation QMS topic and point of contact for the Data Integrity (DI) COE.
Primary SME for site / function for DI related questions and support. Support development and implementation of DI Global Procedures (GPs)
Point person(s) for coordination and deployment of global DI procedures within the site/functional area.
Management of ongoing DI GEMBA program across site / functional area.
Ensure that data management systems are configured and maintained to meet regulatory requirements and industry standards
Champions the DI mindset and culture on site via a developed program and delivery plan..
Develop and/or deliver training programs on data integrity principles, best practices and regulatory requirements for employees and contractors across site.
Responsible for ensuring site DI governance process is in place and visible from the sites operational areas to site Leadership Teams
Develops and coordinates distribution of DI materials and information across the site / network
Responsible for inspection readiness / inspection responses
Conducts regular reviews and assessments of data integrity risks and implements CAPA as needed.
Single point of contact for integration of Quality Risk Management as it relates to data governance and GMP records
Serves as SME on data integrity matters and provides guidance. Supports site investigations and CAPA identification related to DI events.
Responsible for collection and presentation of DI compliance (metrics), obstacles and challenges to site management, including a review of the DI topic at the Site Quality Council Meeting per the QC standard.
Leads efforts to monitor and audit data processes and systems to ensure compliance with regulatory requirements (e.g. FDA, EMA, ICH)
Drives continuous improvement initiatives to enhance data management processes, systems, and capabilities.
Stays current on emerging trends, technologies and regulatory developments related to data integrity in the biotechnology and vaccine industries.
Qualification
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Required
Bachelor’s degree (BA/BS) with eight (8) years applied professional work experience in one of the following pharmaceutical work areas: data management, quality assurance, compliance, manufacturing operations, technical operations, or IT. OR Master’s degree (MA/MS) with six (6) years applied professional work experience in one of the following pharmaceutical work areas: data management, quality assurance, compliance, manufacturing operations, technical operations, or IT.
Applicable experience, 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 (ex. LIMS, ELN)
Strong working knowledge of laboratory, manufacturing and support systems, and associated business processes.
Excellent communication, leadership, and problem-solving skills
Very skilled at organizing complex topics, strong project management skills, able to handle multiple tasks concurrently
Ability to distill large quantities of data into simple messages and to assess and provide recommendations
Adapts to rapidly changing business needs
Fosters positive, transparent and productive relationships
Proven history of challenging the status quo of business standards and processes with the ability to propose solutions
Proven history of developing strategic plans and implementing on time
Ability to be decisive and influence management with demonstrated leadership skills
Experience in managing cross-functional initiatives or programs
Understanding and experience in various business methodologies (ex. Lean thinking, Agile methodology, Design thinking, Six sigma, etc.)
Preferred
Experience in a Quality organization (quality systems) and/or Manufacturing operations (Automation) preferred
Company
Merck
Merck is a biopharmaceutical company that offers medicines and vaccines for various diseases.
10,001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$5.59MKey Investors
Private Capital AdvisorsGavi, the Vaccine Alliance
2018-11-25Post Ipo Equity· $0.59M
2016-01-21Series Unknown· $5M
1980-12-19IPO· nyse:MRK
Leadership Team
Kenneth Frazier
CEO and Chairman of the Board
Betty Larson
Executive vice president and chief human resources officer
Recent News
2024-06-05
2024-06-05
2024-06-03
Company data provided by crunchbase
