Compliance Specialist

Role Summary

Compliance Specialist based in Framingham, MA. Responsible for contributing to the development and maintenance of an effective compliance program, ensuring operations meet regulatory requirements and international standards, and supporting continuous improvement across GMP walkthroughs.

Responsibilities

• Contributing to the development and maintenance of an effective compliance program
• Ensuring all operations comply with relevant regulatory requirements and other international standards
• Providing training and guidance to employees on compliance-related topics
• Maintaining compliance-related documentation, ensuring accuracy and completeness
• Identifying potential compliance risks and contributing to the development of strategies to mitigate them
• Supporting the investigation and reporting of compliance incidents
• Managing CAPA to address compliance incidents and preventing recurrence
• Contributing to continuous improvement initiatives to enhance compliance processes and systems
• Preparing and participating in internal and external audits and regulatory inspections
• Organize/optimize the GMP walkthrough process across the organization using the GoGemba system
• Participate as the primary coordinator between area owners, quality teams, and upper management
• Schedule and coordinate all GMP walkthroughs in the GoGemba system
• Communicate the walkthrough planning tool (Excel) on the Teams channel
• Monitor walkthrough completion status and follow up on outstanding items
• Provide technical support and troubleshooting for GoGemba system users
• Track and report KPIs and metrics to upper management
• Identify continuous improvement initiatives for the walkthrough program
• Gather participant feedback to enhance program effectiveness
• Update standard operating procedures (SOPs) as needed
• Collaborate with GoGemba Admin to implement system improvements

Qualifications

• BS - Pharmaceutical Sciences, Chemistry, Biology, or a related scientific discipline ‚Äì preferred
• 2+ years of relevant experience in the pharmaceutical or healthcare industry
• Additional certifications in Quality Management Systems or Regulatory Compliance would be beneficial

Skills

• In-depth understanding of pharmaceutical regulations, guidelines, and standards (e.g., FDA, EMA, ICH)
• Ability to analyze complex compliance issues, identify root causes, and develop effective solutions
• Strong verbal and written communication skills to effectively convey compliance requirements and updates to various stakeholders
• Proficiency in managing multiple compliance projects simultaneously, ensuring timely completion and adherence to standards
• Keen attention to detail to ensure accuracy in compliance documentation, audits, and reports
• Strong communication skills (written and verbal)
• Proficient in scheduling and coordination utilizing GoGemba tool
• Proficient in Microsoft Excel - Experience with SharePoint and Microsoft Teams
• Problem-solving and troubleshooting abilities
• Attention to detail and follow-through
• Ability to work with cross-functional teams