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Quality Systems Manager


  • Unicon Pharma Inc
  • 06/27/22
  • Cambridge, MA
  • 02142
  • $85+ / Hourly
  • Contractor
Manager, Quality Systems responsible for supporting Quality Management Systems (QMS) oversight, and metrics and trending reporting for GxP Internal Audits, Vendor Audit management, Deviations, CAPAs, Effectiveness Checks, Change Control, Product Complaints, Lab Investigation. Additionally, the Manager partners with internal departments to develop and support QMS process improvement implementations that meet business and regulatory requirements.

Provides support for Quality Systems management, development, and continuous improvement of QMS Objects (i.e. workflows), and audit management to support GxP operations (early-stage clinical, late-stage clinical and future commercial operations).
Supports monitoring the performance of the Quality Management System. This includes formally tracking compliance to established quality standards, monitoring the effectiveness, and establishing a continuous improvement program.
Collaborate and assist GxP business partners in incident evaluations, investigations, risk assessments, management, and remediation as a compliance lead as needed.

Bachelor degree in a life sciences discipline with a minimum of 8 years of pharmaceutical/biotechnology experience and managing/administrating a QMS or another Quality System.
Excellent communication, collaboration, partnership, influencing and negotiation skills.
Demonstrated ability to coordinate, and manage multiple functional groups.
Personal accountability, high level of respect and integrity, and ability to empower co-workers.
Strong attention to detail, strong compliance mindset, and strong written and verbal communication and technical writing skills

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