Senior Manager, Supply Chain Quality Lead

Biogen•Cambridge, MA

1d•Hybrid

About The Position

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.

Requirements

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

Nice To Haves

Experience supporting global teams across multiple time zones

Responsibilities

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

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