Supervisor, Data Integrity & Data Management
We are seeking a Data Integrity & Data Management Supervisor for a direct-hire opening with a global pharmaceutical company near Canton, MA. This role is responsible for complying with regulatory requirements and company established requirements for data integrity associated with automated and manual/paper-based processes.The incumbent assures that the site is in compliance with the specific US-regulations, including cGMPs.
- Responsible for performing the site's data integrity requirements, including routine audit trail reviews and audits of systems on a routine basis.
- Responsible for supporting the site in evaluating data integrity assessments related to new and existing systems including, but not limited to, manufacturing and laboratory systems to ensure compliance with regulatory requirements and company established requirements for data integrity.
- Responsible to support the site with data integrity related investigations and evaluating any changes to computerized systems are consistent with regulatory expectations.
- Responsible to monitor Data Management related metrics applicable at the site regarding data management and data integrity.
- Responsible for evaluating mitigation and remediation strategies (e.g. forensic investigations) across all sites when data integrity gaps are identified, including but not limited to engagement with third parties for the performance of remediation activities.
- Maintains awareness of data integrity regulatory actions (FDA 483s and Warning Letters), current regulatory trends and their impact on existing systems and recommends internal process improvements.
- Able to establish operational objectives and work plans, maintaining awareness of the impact to processes, efficiency, and budget.
- Works with regional and global personnel to interprets and administer company policies, processes, and procedures that may affect site.
- Responsible for being primary support for Data Integrity during internal and external inspections and ensuring site personnel are trained to applicable level of awareness.
- Minimum of Bachelor's degree required. Advanced degree in computer science, computer engineering, or mathematics highly desirable.
- Minimum 3+ years of related work experience working in a regulated industry, such as Pharmaceutical/Medical Device, preferably in a manufacturing operation setting.
- Accomplished expert with computerized systems and an analytical mindset for identifying potential weaknesses and gaps.
- Knowledge of GxP regulations and Good Automated Manufacturing Practices (GAMP) principles with a preferred emphasis in 21 CFR Part 11, 210, 211 and related regulatory guidance.
- Project Management skills required..
- Excellent computer skills required (e.g., Microsoft Word, Excel, Access, PowerPoint, Visio)
Experis is an Equal Opportunity Employer (EOE/AA)
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