Senior Associate I, Quality Assurance

Biogen SANDBOX•Research Triangle Park, NC

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 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 MBA/MS degree with 6+ years related experience
Practical knowledge of relevant FDA/EMA regulations.

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.
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.
Works across all Quality Departments within RTP as needed to ensure appropriate level of Quality Oversight.
May perform review/approval of change control documents and activities associated with change control implementation as well as review/closure of Preventative Maintenance and Corrective Maintenance work orders.
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.