Sr Associate I, Quality Assurance

Job Description

About This Role

The primary responsibility of the Senior QA Associate I in the Quality Systems team is for managing DP (Pharma) and DS (Bio) site inspections (set up, inspection team support, response management and closure for partner and regulatory agencies) and completing regulatory requests for partner and Biogen products. This role plays develops the strategy and processes for site inspections, which include on-site and virtual inspections. The person will lead/support site inspection readiness, learn the various roles of inspections, ensure timely and accurate response follow up, and identify improvements for the RTP site inspection and regulatory request processes.

Additional responsibilities include performing timely and accurate issuance of GMP documents and records (BPRs, SLRs, Labels, and Logbooks) required to support internal site operations, and the review and approval of site-specific GMP documents (Work Instructions, Master Production Records, and Solution Records) for compliance to applicable regulatory and corporate guidance documents, and consistency with business source documentation.

WhatYou’llDo
  • Manage on-site and virtual health authority and partner inspections for the DP (Pharma) and DS (Bio) sites. This includes inspection preparation, inspection logistics, and activities during the inspection.
  • Ensure the timely completion of inspection responses, corrective actions, and ultimate close out of inspections.
  • Ensure the timely completion of regulatory requests from various health authorities for partners and Biogen.
  • Review and approve site-specific GMP documents and records. Assess and approve document change controls for the RTP DS/DP sites.
  • Issuance of Batch Production Records, Solution Lot Records, Labels, and Logbooks
  • Identify and implement Quality System improvements
  • Develop and deliver training on basic GxP quality systems. Provide mentorship and training within and across functions

Who YouAre?

The Senior QA Associate I in the Quality Systems team manages inspections for both of the RTP sites. They will need to understand the inspection process, understand current regulatory concerns and focal points for audits, ensure holistic responses to audit observations, and closely manage the closure of actions from an inspection. You will interact and communicate with senior leadership and partners as activities are progressing. This candidate will have to be able to serve as a project manager and understand the priorities of the business for inspections, make effective decision, work across the sites, and lead/influence leaders.

Qualifications

Required Skills
  • Bachelor’s Degree with 5-8 years of applicable experience
  • Master’s Degree with 4-6 years of applicable experience
  • Demonstrated leadership abilities and can lead complex problem-solving initiatives across functions (Coordinates activities across these groups to complete compliance activities)
  • Proficient understanding of internal quality systems and requirements
  • Strong oral and written communication skills; ability to communicate/influence management, peers and subordinates effectively
  • Strong organizational and project management skills; ability to multi-task and coordinate multiple activities in parallel
  • Demonstrated troubleshooting and problem-solving skills
  • Knowledge of FDA/EMEA regulations and compliance

Preferred Skills/ Decision making
  • Able to make autonomous quality decisions and solve various complex tasks with the support of supervision
  • Works independently on assigned tasks, with ability to flex and respond to unexpected situations/demands.
  • Identifies system/compliance gaps and identifies solutions to complex problems that require ingenuity, creativity, and teamwork.
  • Makes informed, timely decisions routinely in an independent fashion. Assumes responsibility and accountability.
  • Identifies strategic opportunities and supports the deployment of strategic vision of the Quality organization.




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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