Quality Specialist (GCP/GLP)
Massachusetts, United StatesQuality Management
ProtaGene is a world leading analytical CRO partner for the global biopharmaceutical, gene, and cell therapy industries. From research support through product CMC characterization, clinical testing, and post-market release lifecycle management and monitoring, we provide some of the most advanced, integrated, and quality system driven analytical capabilities available. Our deep history of analytical leadership in protein-based therapeutics stems from the merger of Protagen Protein Services with BioAnalytix in 2019, and subsequent merger in 2021 with GeneWerk’s unique capabilities in vector safety, integration site analysis, and gene editing bioinformatics. Our organization operates in four sites in Europe and North America, and works with leading large pharma, biopharmaceutical, and gene therapy companies worldwide.
We are seeking an experienced and detail-oriented individual to support the Quality Management systems and processes in our ProtaGene US Site located in Burlington, MA; a fast-paced, high growth CRO environment serving leading pharma in biologic development and cell & gene therapy. This is a unique opportunity to join a quickly growing, dynamic team, and play a key role in supporting next-stage growth of the quality function in delivering comprehensive CMC and clinical data in the pharma space.
This individual will report into the Senior Manager, Quality for the US and play a key role in supporting and establishing quality excellence at the US site, supporting GCP, and GLP activities. This is a full-time, onsite position. Title and salary commensurate with experience.
- Maintaining and comprehensive support of the Quality Management System.
- Perform internal audits and inspections in accordance with GCP, GLP and GCLP requirements.
- Operate as QA for ProtaGene’s reports and deliverables, including ensuring Data Integrity in processes, data packages and Final Report Packages to the Company’s external Pharma and Gene Therapy client partners.
- Coordinate with internal stakeholders to integrate quality into projects and project deliverables.
- Participate in audits from external organizations, customers, and regulatory agencies.
- Review of equipment, system, and method qualification/validations.
- Plan and conduct qualification of e.g., subcontractors, and vendors (including service providers).
- Organize and supervise employee training.
- Create, revise and review documents such as SOPs and work instructions.
- Support the CAPA process that includes deviation, risk analysis and change control management.
- Communicate with domestic life science customers/auditors.
- Scientific or Engineering Degree (BSc, MSc).
- Minimum of 3+ years working in Quality Assurance preferably in the field of biotechnology, pharmacy, or cell/gene therapy.
- Direct experience in the areas of GCP and/or GLP is highly preferred.
- Experience participating in FDA inspections, and/or in certifications for CAP/CLIA is desirable.
- Strong quality awareness and ability to translate regulation/guideline knowledge into practical work.
- Ability to organize and drive performance of the quality assurance system.
- Excellent verbal and written communication, with organizational, and critical thinking skills.
- Operate with integrity, commitment, and a motivated work ethic.
- Ability to adapt to changing priorities, and to work in a team as well as independently.
- Strong interpersonal skills.
- Attention to detail, execution of tasks, and accountability necessary.
- Must be flexible, willing to take initiative, and highly collaborative.