Responsibilities:

• Serve as the primary point of contact for resourcing and guidance of the Product Release team.
• Review and approve in-process tasks related to product and/or service provision.
• Develop and oversee onboarding and training programs for Analysts within the Product Release team.
• Act as the subject matter expert and point of contact for the Software Development Life Cycle (SDLC) process.
• Develop, draft, and revise controlled Validation Deliverables, while driving continuous improvement of product release procedures and practices.
• Provide ad hoc training to Operations staff on compliance procedures associated with product release activities.
• Product Release Responsibilities:
• Review and approve in-process tasks related to product and/or service provision.
• Generate, review, and maintain Validation Deliverables documentation, ensuring compliance with established procedures and processes.
• Maintain validation documentation within the Quality Management System (QMS) in accordance with company procedures.
• Support Operations staff in the development, drafting, and revision of controlled Validation Deliverables.
• Act as the primary representative and resource to Operations staff regarding product release matters.
• Assist in the preparation, review, and maintenance of reports related to identified product events.
• Participate in Root Cause Analysis (RCA) meetings with Operations and provide input on the identification and documentation of Corrective and Preventive Actions (CAPA) for discrepancies or product failures.
• Support completion of outstanding CAPA items in collaboration with appropriate stakeholders, as they relate to product release.
• Assist the Governance unit in preparing for external audits related to product release activities.
• Perform Quality Control (QC) reviews of controlled Quality Management System (QMS) documents, including SOPs, Work Instructions, and Policies, and provide feedback to relevant stakeholders as needed.

Education:

• M.S. degree and minimum 2 years of related experience OR BS/BA degree and minimum 4 years of related experience
• Certification in Quality Assurance or Regulatory Affairs preferred

Experience:

• Minimum 2-4 years of relevant working experience within a regulated environment
• Substantial working knowledge of FDA regulations (21 CFR Part 11, EU Annex 11) regulations and current industry best practices
• Knowledge of U.S. and international regulatory standards and guidelines
• Relevant experience preferably in the clinical trial industry, IRT, or CRO experience is highly desired.
• Experience with a QMS and LMS preferred

Skills:

• Strong communication (written and verbal), organizational, and interpersonal skills.
• Strong decision-making skills
• Project management skills and high level of attention to detail.
• Demonstrated ability to work in a fast-paced, cross-functional team environment.
• Position requires a highly diplomatic and tactful individual with exceptional critical reasoning skills
• Experience in developing SOPs in for quality assurance and compliance.
• Strong collaboration and development skills.
• Proactive team player enthusiastic with high work ethics
• Proficient in Microsoft Office applications (Outlook, Word, Excel, Visio, Microsoft Project, Power Point) and Adobe Acrobat Professional.