Sr Associate I, Quality Assurance Operations

About This Role

This is a full‑time, on‑site position with M‑F business hours. The Senior Associate I is responsible for the oversight of key strategic, tactical, and operational aspects within Quality Assurance at the Biogen Research Triangle Park facility. The role requires advanced understanding of Quality Management Systems and applies that knowledge by coaching peers and ensuring continuous improvement cross‑functionally. It includes guidance on regulatory compliance, technical expertise, independent assessment, and expert consultation to Manufacturing, Quality Control, Engineering, Validation, and other supporting departments in accordance with site and corporate policies, cGMP, safety, environmental, and HR procedures.

The incumbent will assist with regulatory and third‑party audits, aid in the development and implementation of Global Quality Systems, and manage quality projects and initiatives.

• Batch Record Review: Review all quality‑related documents (e.g., production records, procedures, work instructions, raw data, in‑process testing, raw material disposition) for compliance and determine acceptability for GMP production activities and/or release of product for further processing and/or distribution.
• Exceptions and CAPA: Assess the criticality of exceptions/investigations for product impact, conduct investigations, perform thorough reviews, provide feedback to department owners, and help identify potential process areas that contributed to defects.
• Controlled Document Workflows: Review GMP controlled documents to ensure changes are accurately reflected in the workflow, compliant with regulations, and will not adversely affect product quality; set appropriate release dates.
• Area Walkthroughs and Compliance Gap Identification: Complete area walkthroughs and work observations to identify compliance gaps.
• Collaboration with Manufacturing and SMEs: Work with manufacturing and area subject‑matter experts to identify appropriate corrective actions.
• Issue Resolution: Support the resolution of technical and compliance issues of moderate complexity.
• Quality Systems Implementation: Help implement quality systems, system improvements, and technical problem solving.
• Management Support: Assist Quality Assurance Management with day‑to‑day implementation of the Quality Management Systems required to maintain cGMP compliance and ensure product safety, efficacy, and purity.
• GxP Training Support: Provide support and/or assist in GxP quality systems‑related training.
• Mentorship and Cross‑Functional Training: Provide mentorship and training within and across functions.
• Equipment Oversight: Support area release, changeovers, equipment release, visual inspection of equipment, shutdown activities, equipment tracking workflows, work order reviews, and approvals.
• Other duties as assigned.

You are task‑oriented, focused on continuous improvement, curious, eager to learn, and ask copious questions. You excel at root cause analysis, possess excellent communication and collaboration skills, think logically, and can work across all levels of the organization.

• Bachelor’s degree required, preferred in life science.
• Minimum 4 years of relevant quality experience within a GMP pharmaceutical or biotech manufacturing environment.
• Experience reviewing and approving batch records.
• Experience conducting and explaining investigations to quality management and regulatory bodies.
• Advanced understanding of global quality systems applications, principles, concepts, practices, and standards and GxP regulations.
• Ability to work effectively, both independently and within a team framework across all business areas and levels locally and globally.
• Excellent written, verbal, and interpersonal communication skills required to condense complex subjects into key bullet points, articulate recommendations and decisions to quality management and regulatory bodies, and develop strong networks cross‑functionally to drive collaboration, processes, and decisions.

• Experience in drug substance manufacturing, biologics, and/or Contract Manufacturing Organizations (small molecule).
• Experience supporting…