Sr. Associate, Global Quality Assurance - Complaints

About Technical Operations

BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.

Summary

Senior Associate, QA SUMMARY This position reports to the Associate Director of Post Market Quality within the Global Quality Assurance (GQA) Organization and is responsible for supporting the Commercial and Clinical Product Complaints system and associated activities in a cGMP regulated environment. RESPONSIBILITIES Responsibilities include but are not limited to the following:

• Perform all aspects from intake through closure of Product Complaints. Maintain QA oversight and collaborate with a variety of functional departments to complete Product Complaint Investigations.
• Compile relevant Product Complaint trend/performance metrics
• Support annual product reviews and quality management reviews by providing requested complaint related data
• Assist in the evaluation of practices and systems for potential process improvements
• Support inspection preparation and participate in regulatory inspections, presenting Product Complaint process and practices as needed
• Manage system ownership of the electronic Product Complaint system module within Veeva QMS
• Train relevant personnel on how to utilize Veeva QMS for Product Complaints
• Maintain current knowledge of industry standards and regulatory requirements for products developed or manufactured by BioMarin
• Manage and complete assigned projects
• Other duties as assigned
  
  
  

EXPERIENCE Required Skills:

• 5 years’ experience in a GMP regulated environment, with demonstrated knowledge or proficiency working within quality systems (including Complaints, Deviations and CAPAs).
• At least 1 year Product Complaint or Deviation investigation owner experience required.
• Familiarity with one or more of the following: Small Molecules, Biologic, Devices, Combination products and Gene Therapy. Combination product and/or device complaint experience preferred.
• Ability to comprehend technical information related to operation processes and regulatory expectations.
• Strong problem solving and analytical skills.
• Effective verbal and written communication skills.
• Experience in report/technical writing.
• Highly organized with strong attention to detail and ability to prioritize work.
• Experience and proficiency with standard office software applications and computer systems – Microsoft Office Suite required.
  
  
  

Desired Skills:

• Experience participating in regulatory inspections presenting or defending departmental functions preferred.
• Experience with Veeva QMS preferred.
• Understanding and familiarity with FDA & European regulatory requirements, guidelines, and recommendations for Product Complaints preferred. (Understanding of regulatory guidelines for other countries a plus).
  
  
  

EDUCATION BA or BS degree (physical or biological science preferred but not required). Equivalent experience may be considered. SHIFT DETAILS This is a Day shift position, Monday through Friday. ONSITE, REMOTE, OR FLEXIBLE This is a flexible position with the requirement of two days per week on site in Novato.

Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

Equal Opportunity Employer/Veterans/Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Who We Are

BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.

Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.

Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we’ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.