Associate Director of Quality Assurance (GCP/GLP)

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.