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.