Responsibilities

• Support the development and oversight of robust quality systems, including both implementation and operation at the site level.
• Review systems and analyze data (paper or electronic) to identify specific data integrity and data consistency issues with oversight.
• Contribute to the site inspection preparation, management and response process.
• Support quality management review and assessments including periodic compliance audits of the site QMS.
• Represent Quality Assurance on project teams and in meetings.
• Work with the management team to integrate quality risk management concepts and philosophies into the overall Quality System.
• Facilitate the use of a risk-based approach for decision-making within the QMS. Properly escalate high-quality risks per procedure.
• Monitor and report key performance indicators as appropriate.
• Support the continuous improvement and oversight of the Quality Management System program.
• Assist in implementing new technologies to improve the compliance and efficiency of QS operations.
• Adhere to all GMP requirements and perform other related duties as assigned.

Qualifications

• Minimum of a bachelor's degree, preferably in a Life Sciences field.
• A minimum of 3 years of experience in biopharmaceutical based GMP manufacturing operations.
• Ability to apply a phase appropriate, risk-based approach to QA operational decisions.
• Experience supporting cGMP manufacturing operations through administration and enforcement of the Quality Management System.
• Previous Quality Assurance experience required, including Data Integrity (ALCOA+) compliance.
• Previous experience in quality risk management.
• Previous experience as an internal auditor considered a plus.
• Working knowledge of cGMP/ICH/FDA/EU regulations and guidelines and experience in the US and international regulatory agency inspections a plus.
• Proficient in using Microsoft applications (MS Word, MS Excel, MS PowerPoint).
• Strong follow-up and organizational skills.
• Experience with viral gene therapies and/or orphan disease indications a plus.
• Direct experience reviewing and/or authoring standard operating procedures.
• Ability to work well independently and within a team.
• Excellent oral and written communication skills with technical writing experience required.