Job Title: Regulatory Compliance Officer
As a key member of the quality control team, you will play a crucial role in ensuring compliance with regulatory requirements and industry standards. Your primary responsibility will be to support the organization in meeting compliance targets through laboratory investigation and deviation management.
The ideal candidate will possess excellent communication and collaboration skills, with the ability to work effectively with cross-functional teams. You will be responsible for coordinating and managing preparation for regulatory inspections and internal audits, ensuring that the organization is audit-ready at all times.
You will also act as the primary point of contact during inspections or audits, addressing inquiries and providing documentation as needed. In addition, you will be responsible for organizing and maintaining quality records, including change controls, corrective action plans (CAPAs), and workflows.
Your duties will also include leading cross-functional teams during change control or CAPA events, ensuring alignment on strategies and resolution plans. You will review, edit, and revise controlled documents to ensure compliance with written procedures and regulatory standards.
Furthermore, you will monitor open compliance records, such as CAPAs, change controls, and workflows, to ensure timely resolution and closure. You will also report quality system metrics to relevant departments to track performance and identify improvement areas.
In this role, you will have the opportunity to represent the quality control team in interdepartmental meetings and collaborate with stakeholders to ensure QC perspectives and requirements are considered.
Requirements:
* BS/BA in Life Sciences or equivalent degree
* 2+ years relevant experience in pharmaceutical or biotechnology industries
* Excellent verbal and written communication skills
* Collaboration and teamwork skills
* Able to work effectively in a fast-paced environment
Benefits:
We offer a comprehensive benefits package, including health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees.
Equal Opportunity Employer:
We are an equal opportunity employer and welcome applications from diverse candidates.