Manager, Quality Assurance (Complaints)

Location
Rensselaer, NY, United States
Posted
Sep 03, 2020
Ref
21424BR
Required Education
Bachelors Degree
Position Type
Full time
Assoc/Manager/Sr, Quality Assurance (Complaints).

We are currently looking to fill a Manager, Quality Assurance (Complaints). Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. Our Manager leads a team responsible for the investigation of product quality complaints received for commercially distributed and clinical products.

As a Manager, Quality Assurance (Complaints), a typical day might include the following:
• Reviewing complaint data and investigation reports, BPDR memos, QC reports and batch records
• Leading, training, developing, and supervising Compliance Specialists, Senior Specialists.
• Coordinating workload to ensure timely completion of investigation related tasks
• Planning and managing department projects
• Ensuring inspection readiness for complaint investigation related items
• Supervise day to day operations
• Reviewing/Approving Process Compliance items within Complaint module
• Lead Root Cause Analysis discussions
• Supporting customer and regulatory audits and inspections

This role might be for your if:
• Enjoy facilitating Continuous Improvement initiatives
• Excel in identifying gaps in existing processes and systems and propose solutions.
• Will drive towards resolution
• You are willing to work and collaborate in an ambiguous and dynamic environment

To be considered for the Manager, Quality Assurance (Complaints), you must have the following; BS/BA in scientific discipline or related field with 7+ years of Quality Assurance related work experience in biotech or pharmaceutical industry. At the Associate Manager level a BS/BA in scientific discipline or related field with 6+ years of Quality Assurance related work experience in biotech or pharmaceutical industry is required. To be considered for a Senior Manager level BS/BA in scientific discipline or related field with 8+ years of Quality Assurance related work experience in biotech or pharmaceutical industry is required. At all levels previous experience and knowledge of deviation management and/or complaints requirements and systems is preferred. Previous leadership/management experience is required. Level is determined based on qualifications relevant to the role.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.