Qualifications

• . Who You Are You are a quality-minded professional with hands-on GCP experience and a deep understanding of clinical operations and regulatory expectations. You are confident in leading risk-based quality assessments, managing CAPAs, and supporting inspections. You’re a team player with excellent communication skills, and you thrive in a cross-functional, fast-paced environment. Required Skills Bachelor’s degree required. Minimum 5 years’ experience in clinical research, clinical quality, or clinical compliance required. Strong working knowledge of GCP and global clinical trial regulations (e.g., ICH, CFR, EU Clinical Trial Regulation). GCP Quality experience required. GCP inspection experience required. Hands-on experience supporting regulatory inspections and audits. Proven experience conducting investigations and managing CAPAs. Knowledge of clinical trial systems, quality metrics, and risk management. Excellent facilitation, communication, and decision-making skills. Ability to manage multiple priorities and influence cross-functional stakeholders. Preferred Skills Master’s degree or advanced degree in a life sciences, quality, or regulatory field. Clinical Research Associate (CRA) experience or direct experience with clinical investigator sites. Experience in a Quality role supporting clinical or pharmaceutical operations Experience working with CROs or external vendors.

Benefits

• ? Our mission to discover, develop, and deliver therapies for neurological and rare diseases unites us in purpose. We are driven by science and compassion, working collaboratively to overcome obstacles and make a meaningful impact on patients’ lives. At Biogen, we pioneer together. We thrive together. Job Level: Management

Additional Information

Job level: Management Additional Information The base compensation range for this role is: $134,000.00-$179,000.00 Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity. Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance. In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being; including, but not limited to: 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 Why Biogen? We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives. At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about Biogen. 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. We’re united by a shared purpose, proud of our work, and inspired by one another and the lives we strive to change. We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives. Scam Advisory: Please be cautious of scam recruitment offers claiming to be from Biogen. All legitimate correspondence from a Biogen employee will come from a "@biogen.com" email account. Learn more about scams and fraudulent job postings here.