Associate Director of Quality Assurance (GCP/GLP)
- Location: Burlington, Massachusetts, United States
ProtaGene is a world-leading analytical CRO partner for the global biopharmaceutical, gene, and cell therapy industries. We provide advanced, integrated, and quality system-driven analytical capabilities, from research support through product CMC characterization, clinical testing, and post-market release lifecycle management.
Candidate Role:
We are seeking an experienced QA professional to support and evolve the quality management systems at our ProtaGene US Site in Burlington, MA. This individual will work in 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 dynamic team and play a key role in supporting the growth of the Quality function.
This individual will report to the Sr. Director of Global GCP/GLP compliance and will work closely with the US Site VP and the Global Quality team. They will help expand and shape ProtaGene's US-based Quality culture, including GCP and GLP compliant business units.
This is a full-time, onsite position. Title and salary commensurate with experience.
Responsibilities:
- Drive expansion of the Quality Management System(s) in the US.
- Lead and participate in third party and regulatory audits including preparation and responses.
- Oversee qualification of equipment, systems, and suppliers.
- Organize and supervise employee training.
- Create, revise, and review documents such as SOPs and work instructions.
- Oversee and develop CAPA, deviation, risk analysis and change control management.
- Communicate with domestic and international pharmaceutical and life science customers and auditors.
- Interact, report, and collaborate with the PGN Global QA team.
- Conduct QA in the company's programs, ensuring Data Integrity in processes, data packages, and reports to external pharma and gene therapy partners.
- Ensure appropriate definition, development, and implementation of Quality systems.
- Conduct inspections and internal audits in accordance with GCP, GLP, and GCLP guidelines to ensure corrective actions are addressed in a timely fashion.
- Report on Key Quality Indicators (KQI) to track systemic issues and gaps to drive ongoing continuous improvement.
Job Requirements
- Scientific or Engineering Degree (BSc, MSc).
- Minimum of 5+ years of progressive Quality experience in a regulated environment, preferably in biotechnology, biopharma, and/or cell/gene therapy (deep experience with GLP or GCP preferred).
- Ability to drive cultural changes and establish a strong quality mindset within the organization.
- Experience in preparation and participation in FDA inspections is highly preferred, and/or other accrediting audits as may be required for GLP or GCP compliant laboratories.
- Experience leading the accreditation/certification procedures for CAP/CLIA is desirable.
- Strong quality awareness and ability to apply quality knowledge in practical work.
- Ability to manage and coordinate personnel, as well as organize and drive performance of the quality assurance system.
- Experience in a people management role is strongly preferred.
- Prior experience collaborating with outside clients and regulatory bodies preferred.
- Excellent verbal and written communication, organizational, and critical thinking skills.
- Strong interpersonal skills and the ability to work independently and collaborate in a team setting.
- Attention to detail, execution of tasks, and accountability are a must.
- Must be flexible, willing to take initiative, and highly collaborative.
- Integrity, commitment, and a motivated work ethic.
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