Sr. Supervisor, Quality Assurance

Job Description

About This Role

Sr. Supervisor is responsible for contributing to the oversight of key strategic, tactical, and operational aspects within Quality Assurance at the Biogen Research Triangle Park (RTP) Drug Product (DP) facility. Specifically, this role will have primary oversight of the following activities: (1) Batch Records and (2) Exceptions. It is expected that this role will have 3-5 direct reports and report directly into a Sr. Manager.

WhatYou’llDo
  • Ensures Product Disposition documentation and other documents supporting batch disposition are compliant and determines acceptability for use in cGMP production activities and/or release of product for further processing and/or distribution.
  • Drives Exceptions to closure and ensures compliance with procedures and process including thorough documented root cause analysis and well justified rational supports the stated conclusions.
  • Directs, leads, coordinates, and supports the activities of QA personnel to ensure that all activities are focused upon high productivity and the utmost technical integrity. Provides mentorship and training within and across functions.
  • Supports Quality Management and Operations staff in the coordination of, preparation for and follow up of internal/external audits and inspections as required.
  • Assists QA Management in additional responsibilities related to the day-to-day implementation of the Quality Management Systems required to maintain cGMP compliance, and ensure the safety, efficacy and purity of the products manufactured by Biogen.

Who YouAre

Youare task driven and focused on monitoring information and then taking action to resolve, remediate and/or improve. Collaborative person capable of being both agile and customer focused.

Qualifications

Required Skills
  • Bachelor’s degree strongly preferred
  • Minimally 5 yrs. relevant technical experience; people management experience preferred
  • Experience in drug substance/drug product batch record review and disposition
  • Experience with deviations varying in complexity as both an author and approver
  • Advanced knowledge in FDA/EMA regulations and compliance
  • Strong organizational skills; multi-task
  • Investigative mindset and solid decision making skills

Preferred Skills
  • Experience in aseptic fill/finish manufacturing operation




Additional Information

Biogen’s US Alzheimer’s Franchise is looking to recruit proven and ambitious sales achievers with at least five years of experience in pharma, specialty, hospital, med device/capital equipment, and/or biotech sales.
In this field-based, specialty sales representative position you will be called upon to sell our products with key stakeholders in the Alzheimer’s Disease community: including Neurologists and allied health professionals.

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