Sr. Manager/Assoc. Director - Quality Assurance (GCP/GLP)

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.

Candidate Role:

We are seeking an experienced QA professional to support and evolve the quality management systems and processes at our ProtaGene US Site located in Burlington, MA. This individual will have the opportunity to 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 next-stage growth of the Quality function.

This individual will report to the Sr. Director of Global GCP/GLP compliance and while working closely with the US Site VP and the Global Quality team. They will play a key role in expanding and shaping 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.
• Interacting, reporting, and collaborating with PGN Global QA team.
• Conduct QA in the company’s programs, including ensuring Data Integrity in processes, data packages and reports to the Company’s 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 on-going continuous improvement.

• Scientific or Engineering Degree (BSc, MSc).
• Minimum of 5+ years of progressive Quality experience working in regulated environment preferably in the field of 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 participating in inspections by the FDA 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 a must.
• Must be flexible, willing to take initiative, and highly collaborative.
• Integrity, commitment, and a motivated work ethic.