30 days ago on jobs.biogen.com

Sr Associate, Quality Assurance (Product Complaints)

Biogen International GmbH

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Sr Associate, Quality Assurance (Product Complaints)

External Posting TitleSr Associate, Quality Assurance (Product Complaints)Job DescriptionOverview
Provide subject-matter expertise in Biogen Idec’s Technical Product Complaint function as it pertains to product related customer complaints, ensuring compliance with regulatory standards for the markets in which the company's product are manufactured and distributed. This person is expected to lead projects independently, initiate and implement changes and improvements. This role assumes shared administrative responsibilities for relevant software applications, training and development of the team members.

Primary Responsibilities

• Reviews and approves and process incoming cases, ensuring global consistency and compliance. Perform the reviewer function to ensure the investigation was completed, aligned with the procedures, and regulatory requirements.

• Supervises case investigation, monitoring correct CAPA follow up for established root cause.

• Establish internal and external sample investigation capability that meets the need of future products.

• Manage or support team for the investigation of high criticality cases aligning with relevant groups to identify root case and corrective action.

• Performs metric reporting including those related to assigned CMOs, partners, supplier review meetings and audits. Communicate data trending, critical cases to impacted groups and management.

• Identify meaningful KPI for stakeholders/ process and maintain a system to capture and monitor them.

• Develop and maintain a global process for detection and testing of falsified medicines.

• Familiar with the regulatory inspection process and ability to explain departmental processes and answer regulatory inquiries in a timely and accurate manner.

• Manage overall efforts to simplify the processed to reduce errors and non -added value activities. Initiates continuous improvement initiative at a local or global level, to address issues and resolutions with managerial support. Provides leadership to team members on continuous improvement initiatives.

• SME on regulatory and quality requirements. Ensure SOPs alignment with regulations and global procedures, directives and SOP of other departments. Manage discussions with other departments to ensure alignment.

• Manages internal and external training program as well as training content creation and delivery, with particular attention to market-specific needs with respect to contractors, Affiliates or Distributors.LocationZug, SwitzerlandJob CategoryOperations, Technology & Innovation (PO&T)Requisition Number29127BRQualifications
• A minimum of 5 years of experience in Quality Assurance area, preferably in technical product complaints area

• Excellent Communication skills. Ability to communicate at all level in the organization

• Strong attention to detail.

• Good analytical and problem solving skills

• Exceptional team player (ability to direct and participate in cross functional and management teams). Ability to develop strong network across company

• Fluent English is a must, any other European language would be an advantage

• Bachelor or Master’s Degree in life sciences or related faculties preferredEducationn/aAbout BiogenBiogen (NASDAQ: BIIB) is a biotechnology leader that discovers, develops and delivers innovative therapies for the treatment of neurodegenerative and rare 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 companies. 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 Alzheimer’s Disease, amyotrophic lateral sclerosis (ALS), Parkinson’s disease, spinal muscular atrophy and neuropathic pain amongst others.

With more than 7,000 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 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.

Please be advised that all legitimate correspondence from a Biogen employee will come from "@biogen.com" email accounts.

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