Larimar Therapeutics Inc. · 2 days ago
Sr. Manager/Associate Director, Quality, Validation and Data Integrity
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BiotechnologyMedical
Insider Connection @Larimar Therapeutics Inc.
Responsibilities
Provide Quality oversight of Computer System Validation (CSV)/Computer Software Assurance (CSA) activities related to initial implementations, changes, periodic review, maintenance, and decommissioning of GxP systems.
Execute and manage risk assessment, planning, and execution/mitigation activities to ensure computerized systems used to support GxP operations are maintained in a qualified state throughout their lifecycles.
Author and/or review and approve relevant validation documentation, including but not limited to: URS, FRS, CS, DS, IOQ, PQ/UAT, VP, VSR, RA, TM.
Streamline and improve processes for GxP systems compliance in collaboration with IT and the business.
Participate in project teams to provide guidance and approval of project Validation documentation and relevant Change Controls.
Manage the data integrity program, including the timeline of activities for data integrity deliverables (e.g., data integrity assessments, CAPA actions, remediations etc.).
Deliver training on validation and data integrity principles/requirements to foster employee awareness and accountability.
Create and/or revise SOPs and Work Instructions supporting validation and data integrity activities.
Participate in vendor audits/assessments and qualification activities or internal audits involving GxP computerized systems as a Subject Matter Expert (SME).
Support GxP health authority inspections by serving as SME for computerized system and data integrity topics.
Support other Quality activities, as required.
Qualification
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Required
Bachelor's degree in a scientific or technical discipline
Minimum 6 years of experience in a Quality role in the biotechnology/pharmaceutical industry
At least 2 years' experience with computer systems validation
Experience with GxP validation methodology
Strong understanding of 21 CFR Part 11, EU Annex 11 regulations, GAMP 5 concepts, applications, and best practices
Strong attention to detail
Ability to set priorities and meet aggressive timelines
Benefits
Incentive stock options
Comprehensive benefits plan including 401K
Flexible PTO policy
Company
Larimar Therapeutics Inc.
Larimar Therapeutics, Inc. (Nasdaq:LRMR), is a clinical-stage biotechnology company focused on developing treatments for complex rare diseases.
Funding
Current Stage
Public CompanyTotal Funding
$552.68MKey Investors
Alta PartnersAtlas Venture
2024-02-14Post Ipo Equity· $172.5M
2022-09-14Post Ipo Equity· $70M
2021-05-21Post Ipo Equity· $95M
Leadership Team
Recent News
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