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Sr. Associate, Global Quality Assurance - Complaints

Employer
BioMarin Pharmaceutical Inc.
Location
Novato, California
Start date
Nov 17, 2022

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Job Details

Who We Are

For more than two decades, going our own way has led to countless breakthroughs, bettering the lives of those suffering from rare genetic disease. In 1997 we were founded to make a big difference in small patient populations. Now we seek to make an even greater impact by applying the same science-driven, patient-forward approach that propelled our last 25 years of drug development to larger genetic disorders, as well as genetic subsets of more common conditions. Through our unparalleled expertise in genetics and molecular biology, we will continue to develop targeted therapies that address the root cause of the conditions we seek to treat. Applying our knowledge to make a transformative impact is not just a calling, but an obligation to those who will benefit most. The end goal has always been better lives and now we can reach more.

And the more people we reach, the more our impact can grow. We transform lives through genetic discovery.

Our Culture

Our desire to make a positive impact on our patients extends to our employees and BioMarin is committed to fostering an inclusive environment where every person feels seen, valued, and heard – so employees can thrive in all areas of their lives, in and outside of work. We seek to provide an open, flexible, and friendly work environment to empower people and to provide them with the ability to develop their long-term careers. Ultimately, we want to be an organization where people enjoy coming to work and take pride in our efforts to help patients.

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. Come join our team and make a meaningful impact on patients’ lives.

This position reports to the Associate Director in 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
Detailed 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/present relevant Product Complaint trend/performance metrics
• Support annual product reviews and quality management reviews by providing requested data
• Assist in the evaluation of practices and systems for potential improvements
• Support inspection preparation and participate in regulatory inspections, presenting product complaint processes and practices as needed
• Manage system ownership of the electronic product complaint system
• Train relevant personnel on how to utilize 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, Change Controls, Deviations and CAPAs).
• 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.
• Effective communication skills.
• Experience in report/technical writing with proficient organizational, spelling, grammar, and typing skills required.
• Experience participating in regulatory inspections, with experience in presenting or defending departmental functions in audits or regulatory inspections preferred.
• Experience with Veeva QMS preferred.
• Experience and proficiency with standard office software applications and computer systems – Microsoft Office Suite.
• Understanding and familiarity with FDA & European regulatory requirements, guidelines, and recommendations for complaints. (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.


PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Company

BioMarin is a global biotechnology company dedicated to transforming lives through genetic discovery. In 1997, the company was founded to make a big difference in small patient populations, focusing on giving much-needed attention to the underserved communities of those with rare diseases. BioMarin sought to help patients whose voices could not always be heard and treat conditions that were not always in mainstream medical conversations. Throughout its history, BioMarin has worked tirelessly to make a difference by pursuing bold science. The company’s first approved therapy was inspired by a father who refused to accept there was no therapy for his son’s rare diagnosis. That relentless pursuit to change the course of his son’s future through the power of science is at the core of who BioMarin is today.

Through the company’s expertise in genetics and molecular biology, BioMarin has developed eight first or best-in-class targeted therapies that address the root cause of the conditions it seeks to treat, helping to better the lives of those struggling with rare genetic disease. The company’s purposeful and scientifically precise team of physicians and scientists has honed each treatment modality to seek transformative therapies.

Now, BioMarin seeks to make an even greater impact by applying the same science-driven, patient-forward approach that propelled the last 25 plus years of drug development to larger genetic disorders, as well as genetic subsets of more common conditions. Each drug candidate pursued is guided by a fundamental understanding of the genetics and underlying biology of the condition it will address. The company believes that applying its knowledge to make a transformative impact is not just a calling, but an obligation to those who will benefit most. The more innovative solutions developed, the more lives BioMarin can impact.

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Location
California
United States
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