Larimar Therapeutics Inc. · 2 days ago

Sr. Manager/Associate Director, Quality, Validation and Data Integrity

Bala-Cynwyd, PA

Full-time

Onsite

Senior Level

6+ years exp

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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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Quality managementBiotechnologyPharmaceutical industryComputer systems validationGxP validation methodology21 CFR Part 11EU Annex 11 regulationsGAMP 5Aggressive timelinesAttention to detail set priorities