Senior Associate I, Quality Assurance

Biogen SANDBOX • Research Triangle Park, NC

4d

About The Position

The Sr. Associate I provides guidance regarding regulatory compliance, technical expertise, independent assessment and expert consultation to the Manufacturing, QC, Engineering, Validation and other supporting departments. The Sr. Associate I will perform all duties in a manner consistent with site and Corporate policies, cGMP, safety, environmental and human resources policies and procedures, assist with regulatory audits and development and implementation of Global Quality Systems, manage Quality projects and other initiatives, adhere to all regulatory licenses and regulations, interfacing with key internal and external Quality and manufacturing partners, provides coordination and Quality oversight of investigations impacting clinical and commercial programs, performs review of GMP documentation and raw data for compliance to applicable procedures as well as corporate and regulatory guidance The QA Sr. Associate I will also support activities related to interviewing and training of employees, as well as compliance with training policies. The Quality Assurance Sr. Associate I is responsible for contributing to the oversight of key strategic, tactical, and operational aspects within Quality Assurance at the Biogen Research Triangle Park (RTP) facility. The Sr. Associate I should have an advanced understanding of the Biogen Quality Systems and apply that knowledge in coaching and continuous improvement for all Quality Systems cross-functionally.

Requirements

• Minimum of 8+ years of quality experience directly related to position responsibilities; or a MBA/MS degree with 6+ years related experience
• Practical knowledge of relevant FDA/EMA regulations.
• Plans schedules and arranges own activities when acc

Responsibilities

• 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
• Facilitates execution of Quality activities (investigations, preparation of monthly reports, change controls, etc) between strategic partners and Biogen, including preparing, negotiating and adhering to applicable Quality Agreements.
• Represents Quality line function on Tech Transfers and leads/attends Quality subteam, as appropriate.
• Serves as a highly skilled consultant for quality related issues and assuring compliance with regulatory requirements and site procedures
• Assesses criticality of exceptions/investigations for product impact. Performs thorough reviews of investigations and determines potential areas within the process that may have attributed to the exception
• Reviews documents for compliance and identifies gaps in existing quality systems proposes solutions and drives cross-functional improvement initiatives
• Participates in or leads projects and improvements with global impact. Mentors and trains less experienced Associates across Quality Assurance functions

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level