1:00 PM - 2:00 PM
Senior Product Manager Interview
Sarah Jenkins
Location
onsite, Durham, NC, United States
Salary
$65k – $105k/yr
Commitment
Full Time
Level
Middle (2-4 years)
Required skills
Project coordinationData integrityComputer system validationGxP change managementQuality management systemsDocumentation authoringRegulatory compliance21 CFR Part 11EU Annex 11IT system qualificationCAPAChange controlData analysisProject managementSOP developmentTechnical writing
Job Description
Description
Primary Responsibilities: Assist with project coordination and authoring of documentation for IT data integrity strengthening projects, including but not limited to: Acronis implementation and qualification for data backups and recovery. Manufacturing & QC Equipment software upgrades and/or implementation of additional software controls. Execution of audit trail and user access review processes. Implementation of secured USB access control process. Collaborate with IT system owners, business systems owners, validation and product quality to deploy robust data integrity controls across systems and processes. Support GxP Change Management activities to ensure controlled qualification and deployment of IT system changes, record reviews, approvals, and completion of supporting documentation. Serve as SME on QMS records including change controls, continuous improvements, and CAPAs associated with computerized systems and data integrity. Authoring and lifecycle management of IT SOPs and Work Instructions.
Qualifications
Bachelors Degree or equivalent certifications in Information Technology or a related field. 3+ years of pharmaceutical industry IT experience. Working knowledge of Computer System Validation (CSV), Data Integrity principles, and regulatory requirements for computerized systems, including 21 CFR Part 11 and EU Annex 11. Experience with Quality Systems such as Veeva for document authoring and Quality Management (Change Controls, Deviations, CAPAs). Strong attention to detail and a Quality mindset with commitment to accuracy and compliance. Excellent communication and interpersonal skills, fostering collaboration and building strong relationships with internal and external stakeholders. Project management skills with the ability to prioritize tasks, manage deadlines, and track progress effectively. Ability to work independently, prioritize competing activities, and maintain compliance under tight timelines. Relevant experience working with laboratory/manufacturing equipment such as Rotea, Sepax, LOVO, Cue, Prodigy, MaxCyte, Skid Controllers and platform integrations with DeltaV would be a plus. Relevant experience with instruments such as Spectramax, Zetasizer, MACSQuant, SoloVPE, Hamilton, BacT with MYLA software, or other similar laboratory instruments would be a plus.
