Our Sr. Associate I, Drug Compliance ensures that company GMP operations are being conducted in compliance with worldwide regulatory requirements and all applicable procedures and corporate standards. This is accomplished through assessing and auditing suppliers, partners, service providers, and internal systems.
- Plans and conducts audits to confirm that suppliers, partners, service providers, and internal systems operate in accordance with GMP and other applicable worldwide regulatory requirements, and in compliance with company requirements and expectations
- Document audit observations and evaluate their potential impact. This would include evaluating responses to audit findings and ensuring that completed audit reports and responses are maintained for future reference and analysis
- Collaborate with internal customers to determine appropriate courses of action to take in response to vendor related concerns
- Facilitate maintenance of audit databases
- Reviews audit program Standard Operating Procedures as needed
- Minimum of 6 years in pharmaceutical/regulated industry or 3 years in Quality/Compliance with auditing responsibilities
- Proficiency in TrackWise, MS Word, MS Excel, MS PowerPoint, and MS Outlook
- Excellent oral and written communication skills.
- Detail-oriented aptitude
Minimum education required for this position; BA/BS in Life Science.
- Through cutting-edge science and medicine, our company discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases.
- Our company is a pioneer in biotechnology and today the Company has the leading portfolio of medicines to treat multiple sclerosis (MS), has introduced the first and only approved treatment for spinal muscular atrophy, and is at the forefront of neurology research for conditions including Alzheimer’s disease, Parkinson’s disease and amyotrophic lateral sclerosis (ALS).
- Our company also manufactures and commercializes biosimilars of advanced biologics.
- Our global organization of nearly 7,000 employees is committed to a single mission: making a meaningful difference in the lives of patients with few or no treatment options.
- Our company was founded in 1978 and today serves patients in nearly 70 countries.
- We aspire to have the greatest impact on patients and science of any biotechnology company in the history of our industry.
- To us, that means creating novel medicines that benefit individuals and society, and bringing new scientific understanding to diseases for which there are no adequate treatments.
- For nearly two decades our company has led in the research and development of new therapies to treat MS, including the most prescribed oral treatment in the world.
- Now our research is driving revolutionary new MS treatments with the goal of reversing or even repairing damage caused by the disease.
- We are now applying our neurological expertise to solve some of most challenging and complex diseases of the brain, including Alzheimer’s disease, Parkinson’s disease, and ALS.
- As we uncover new insights into human biology, our company is employing cutting-edge technologies to discover potential treatments for rare and genetic disorders.
- Our company is revolutionizing biologic manufacturing, developing the industry’s most advanced plants and processes.
- This expertise is used to produce both original innovative therapies and bio similar that expand patient access to lower-cost medicines.
Our Corporate Citizenship
- The same intellectual discipline and passion that drives our science is reflected in our corporate citizenship, environmental sustainability, and commitment to diversity and inclusion.
- As a company, we are focused on improving science education and limiting the impact of our company on the environment.
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