Sr. Associate II, Quality Assurance

About This Role The Sr. Associate II is responsible for the oversight of key strategic, tactical, and operational aspects within Quality Assurance at the Biogen Research Triangle Park (RTP) facility. The candidate provides guidance regarding regulatory compliance, technical expertise, independent assessment and expert consultation to Manufacturing, Quality Control, Engineering, Validation, and other supporting departments in a manner consistent with site and Corporate policies, cGMP, safety, environmental and human resources policies and procedures. This individual will assist with regulatory and third‑party audits, aid in the development and implementation of Global Quality Systems, and manage Quality projects and other initiatives. What You’ll Do Exceptions and CAPA: Assess criticality of exceptions/investigations for product impact, conduct investigations, perform thorough reviews, and provide feedback to the department owner. Support investigations by analyzing the defect and determining potential process areas that may have attributed to the defect. Write and/or review, and approve minor and major deviations. Lead, coordinate, and ensure timely completion of Annual Product Reviews. Participate in cross‑functional risk assessments to identify, evaluate, and mitigate risks to product quality, patient safety, and regulatory compliance. Establish and maintain data integrity governance aligned with ALCOA+ principles, perform data integrity risk assessments for manufacturing, laboratory, and quality systems. Ensure data lifecycle management from generation through archival and retrieval; develop and deliver data integrity and GMP training; promote a culture of quality and data integrity awareness. Monitor regulatory trends and guidance related to data integrity and incorporate best practices. Batch Record Review and Product Disposition: review quality‑related documents (e.g., production records, procedures, work instructions, raw data, in‑process testing) for compliance and determine acceptability for GMP production or product release. Complete area walkthroughs and work observations to identify compliance gaps. Collaborate with Manufacturing and Area Subject Matter Experts to identify appropriate corrective actions. Support resolution of technical and compliance issues/gaps of moderate complexity. Help implement Quality Systems/System Improvements and technical problem solving. 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. Support and/or assist in GxP quality systems‑related training; provide mentorship and training within and across functions. Other duties as assigned. Who You Are You are task oriented and focused on continuous improvement. You are curious and eager to learn. You ask copious questions and excel at root cause analysis. You have excellent communication and collaboration skills, logical thinking, and can work across all levels of the organization. Required Skills Bachelor’s Degree, preferred in life science. Associate’s Degree plus 7+ years of related experience is also considered. Minimum 5 years of relevant quality assurance experience within a GMP pharmaceutical or biotech manufacturing environment. Experience reviewing and approving batch records, master records, SOPs, and technical documents. Deep understanding of data integrity. Experience conducting and explaining investigations to quality management and regulatory bodies. Experience working on the floor within a manufacturing environment, either as QA oversight or manufacturing operator. Advanced understanding of global quality systems applications, principles, concepts, practices, standards, and GxP regulations. Must 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 to condense complex subjects into key bullet points, articulate recommendations and decisions to Quality Management and regulatory bodies, and develop strong cross‑functional networks. Preferred Skills Experience in drug substance manufacturing, biologics, and/or Contract Manufacturing Organizations (small molecule). Experience supporting product disposition. Strong preference for experience conducting and explaining investigations to quality management and regulatory bodies. Additional Information The base compensation range for this role is: $93,000.00-$121,000.00. Base salary is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills and experience, job location, and internal equity. Regular employees are eligible to receive short‑term and long‑term incentives, including cash bonuses and equity incentive opportunities, designed to reward recent achievements and recognize future potential based on individual, business unit and company performance. Benefits Medical, Dental, Vision & Life insurances Fitness & Wellness programs, including a fitness reimbursement Short‑ and Long‑Term Disability insurance A minimum of 15 days of paid vacation and an additional end‑of‑year shutdown time off (Dec 26‑Dec 31) Up to 12 company paid holidays + 3 paid days off for Personal Significance 80 hours of sick time per calendar year Paid Maternity and Parental Leave benefit 401(k) program participation with company matched contributions Employee stock purchase plan Tuition reimbursement of up to $10,000 per calendar year Employee Resource Groups participation Equal Opportunity Statement All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E‑Verify Employer in the United States. #J-18808-Ljbffr Biogen, Inc.