This position will be hybrid (3 days per week on site) and can either sit at our Cambridge MA location OR our Research Triangle Park, NC location

About This Role

The Sr Manager, Supply Chain Quality Lead is responsible for providing oversight and support to all distribution quality related activities within the USA. They are responsible for developing quality awareness and inclusion in all processes and facilitate or mentor processes required for the establishment of effective quality management systems. The Sr Manager will liaise with all functions within our Pharma Operations & Technology division and outside to assure seamless processes and patient access to medicines. This person will have QA oversight of logistics of products' distribution worldwide and management of deviations, CAPAs, Change Controls, audits and serialization.

What You'll Do

• Ensure quality and uninterrupted supply through the application of quality measures throughout the supply chain to the patient, as well as the appropriateness of quality systems to stay in compliance with regulations

• Approve shipping qualification for passive and active cooling in transportation, provide support for ex-US internal logistics shipping qualification

• Ensure regulatory inspection readiness for distribution

• Provide oversight of distribution related procedures for USA including oversight of distribution partners

• Establish and maintain Quality Agreements to assure product quality and uninterrupted supply

• Hold regular Quality Management Reviews with distribution partners and monitor performance against applicable KPIs

• Manage specific projects related to product distribution and improvement of standards and compliance

• Support the governance process of Global Commercial Quality

• QA Management of processes related to suspect or illegitimate medicines, returns and recall

• Quality support of pipeline growth and continuous supply of product

• Participate in the new product launch team for planning and identify associated quality actions need to be implemented in preparation for product launch

• Other duties as assigned

Required Skills

• Bachelor's Degree required, preferred in life sciences, supply chain, or other related

• Minimum of 7 years of GMP and/or GDP (Good Distribution Practices) experience for medicinal/pharmaceutical products within a Quality Assurance logistics environment

• Quality and distribution expertise, including cold chain and deep frozen products

• Outstanding communication skills inclusive of delegation, influencing, stakeholder management, and networking abilities

• Ability to work independently to drive projects to completion

• Vendor Management experience

• Demonstrated experience in resolving distribution issues impacting medicinal products

Preferred Skills

• Experience supporting global teams across multiple time zones

Additional Information

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 onto learn more about our DE&I efforts.

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.