Job Description

About This Role

The Product Complaint Manager provides subject-matter expertise in Biogen 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.

The right candidate will be responsible for a team of 4-8 direct reports to manage the Product Complaint regional team. This function provides leadership and ensures alignment with the functions it interacts with such as regulatory, quality, manufacturing, logistics and local distribution offices worldwide. 

What You’ll Do

· Lead the US Technical Product Complaint team while providing leadership and direction in accordance with departmental and company goals and priorities

· Develop personnel, provide motivation and development plan and ensure adequate training

· Process, review and approve cases, ensuring global consistency and compliance

· Perform the reviewer function to ensure the investigation was completed and aligned with the procedures and regulatory requirement

·TPC US representative in regulatory/ customer audit

· Describe TPC processes and answer inquiries in a timely and accurate manner

· Act as the SME on regulatory and quality requirements for complaint system

· Ensure SOPs align with regulations and global procedures, directives and SOP of other departments. 

· Manage TW system improvement and overall efforts to simplify the process to reduce errors and non -added value activities

· Perform case investigation, monitoring correct CAPA follow up for established root cause

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

· Manage complaints related to Biosimilar products

Additional Senior Manager Responsibilities

· Identify operational and quality improvements

· Lead improvement initiatives and coordinates with global organization to drive for harmonized processes

· Track quality systems and metrics, including deviations, CAPAs, GCC, and documentation as necessary.  Ensure compliance is up to date.

Who You Are

The Ideal candidate is one who enjoys managing and developing team members while ensuring creative and customer focused environment. 

Qualifications

Required skills

· Minimum of 5-7 years (Manager) / 7-10 years (Senior Manager) experience in pharmaceutical or biotech quality environment

· Minimum of 2-4 years of supervisory/managerial experience

· Strong GMP knowledge

· Excellent expertise in Word, Excel, PowerPoint

· Fluent English (written and spoken) is a must

 Education

Bachelor or Master Degree in Life Science or Engineering

 

Additional Information

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.