Job Overview: This role involves supporting Quality Systems and Compliance by managing product complaint handling, acting as document control backup, and assisting with regulatory inspection preparation.
Primary Job Responsibilities:
Manage product complaint intake and coordination with partners for timely resolution and safety compliance.
Develop training and assist in revising handling procedures and reporting to maintain compliance standards.
Act as backup for document control and support regulatory inspection preparation and execution.
Primary Job Requirements:
B.S. in life sciences, chemistry, or engineering with 5+ years in Pharma Quality/Regulatory.
Skilled in managing product complaint processes and adverse event reporting.
Knowledgeable about GxP regulatory compliance, including privacy and documentation.
Experience with Veeva QualityDocs and eQMS preferred.
About Stratacuity:
Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.
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Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.