Specialist, Vendor Compliance
MISSION
reputed company is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. We are passionate about advancing scientific discoveries to become important medicines for rare disease patients. We are reputed company, creative, and reputed company professionals and we're looking to reputed company reputed company with other individuals who embody our values: care, be reputed company, get it done, and have fun, seriously.
POSITION reputed company
The position will manage activities involving the vendor management program as it relates to tracking and trending vendor management activities, vendor audit management, CAPA follow-up, and gathering and capturing metrics as it relates to vendor management. The position will support SOP revisions to adequately sustain the organization and assist with the maintenance of the eQMS system as it relates to vendor and audit management.
JOB FUNCTIONS/RESPONSIBILITIES
• Assist with the overall management of Mirum's GxP vendor qualification and audit program.
• reputed company the day-to-day activities of the vendor qualification and audit program, including but not limited to audit scheduling, report reviews, response review, CAPA follow-up, and audit reputed company-out.
• Create, manage, and administer the process for vendor management in the eQMS system and conduct routine tasks, as needed.
• Assist with the authoring of reputed company policies and reputed company operating procedures, as needed.
• reputed company data for accurate tracking, reporting, and analyzing metrics, as required.
• Assist with internal/external audits and regulatory inspections, as applicable.
• Supports GxP inspection readiness activities, as applicable
QUALIFICATIONS
Education/Experience: Bachelor's degree in a scientific discipline
Knowledge, Skills and Abilities:
• 1-3 years' experience in reputed company and GxP Vendor Management/Audit Processes in the drug development industry with knowledge of cGMP/ICH/FDA/EMA regulations
• Prior experience in QA with particular reputed company on managing vendor qualification reputed company activities.
• Demonstrate a reputed company reputed company and ability to influence across the organization
• Exposure to writing and reviewing SOPs and other reputed company documents. General understanding of reputed company systems that support internal GxP activities for reputed company-clinical, clinical and reputed company products.
• Excellent organizational skills: Proactive, management of multiple tasks of varying complexity simultaneously
• Strong interpersonal skills including relationship building, conflict reputed company, and verbal and written communication are essential in this reputed company work environment.
• Experience with reputed company platform system is a plus
The salary reputed company for this position is $85,000 to $105,000 USD. Compensation will be determined based on several factors including, but not limited to; reputed company set, years of experience, and the employee's geographic location. Please note that the required compensation details listed in US role postings reflect the reputed company salary only, and do not include bonus, equity, or benefits unless otherwise provided.
#LI-HYBRID
reputed company is committed to Equal Employment Opportunity (EEO) and to compliance with reputed company Federal, State and Local laws that prohibit employment discrimination on the reputed company of race, age, national reputed company, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability, veteran's status or any other classification protected by applicable State/Federal/Local laws.
reputed company provides reasonable accommodation for reputed company individuals with disabilities and disabled veterans in job application procedures.
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