93 days ago on jobs.biogen.com

Manager/ Sr. Manager Quality Assurance

Biogen International GmbH

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Manager/ Sr. Manager Quality Assurance

External Posting TitleManager/ Sr. Manager Quality AssuranceJob DescriptionOverview
To oversee quality assurance activities and support GDP and GMP activities of some EU Biogen affiliates. To implement and manage quality systems at these affiliates while ensuring compliance with Biogen’s global quality system requirements, relevant regulatory requirements and applicable licenses. To collaborate with quality counterparts of Distributor markets to ensure product quality all the way to the patient.

Primary Responsibilities

• Provides quality assurance operational support and supervision to 5 EU Affiliates and 4 Distributor markets

• Holds regular Quality Management Reviews with affiliates

• Supports license changes, applications and inspections

• Implements and maintains quality systems for and at Affiliate sites

• Supports recall process and distributed product related issues namely potentially falsified medicinal products

• Monitors market activities and escalates issues immediately

• Supports distribution partners and vendor management program

• Establishes and maintains currency of quality agreements

• Oversees Management Reviews with distribution partners

• Provides quality assurance oversight to Expanded Access programs

• Supports medicinal product and medical device launches and ensures continuous supply of product

• Supports distribution model changes and product serializationLocationZug, SwitzerlandJob CategoryOperations, Technology & Innovation (PO&T)Requisition Number28301BRQualifications
• Minimum of 6 years of experience in pharmaceutical or biotechnology industries in GDP or GMP environment; Responsible Person, QA or Regulatory experience preferred

• Excellent communication skills, able to communicate at all levels of the organization, assertive and diplomatic being able to influence without direct reporting line

• Ability to work cross-functionally and in an international environment with people from multiple cultural backgrounds

• Fluent English ( written and spoken) is a must

• University Degree in life sciences or related faculties preferredEducation*LI- EU3About BiogenBiogen (NASDAQ: BIIB) is a biotechnology leader that discovers, develops and delivers innovative therapies to improve the lives of patients with neurodegenerative diseases, hematologic conditions and autoimmune diseases. Patients worldwide benefit every day from our medicines for multiple sclerosis (MS) and hemophilia. Founded in 1978, Biogen is one of the world’s oldest independent biotechnology company. Our development pipeline is focused on areas of high unmet medical need, as we pursue new therapies for patients suffering from diseases with few or no treatment options. These include programs for secondary progressive MS, Alzheimer’s Disease, spinal muscular atrophy, lupus and amyotrophic lateral sclerosis (ALS), amongst others. With more than 7,500 people worldwide, Biogen is truly a global organization. We are headquartered in Cambridge, Massachusetts, which is home to our research operations. Our international operations are based in Zug, Switzerland and we have world-class manufacturing facilities in North Carolina and Denmark. We offer therapies globally through direct affiliate presence in 30 countries and a network of distribution partners in over 50 additional countries. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status. Please be advised that all legitimate correspondence from a Biogen employee will come from "@biogen.com" email accounts.


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