Director of Quality Assurance

Role Summary

Director of Quality Assurance responsible for the strategic development and execution of CAMP4's quality assurance programs and all quality-related decisions. Reports to the SVP of Technical Operations. Location: Cambridge, MA.

Responsibilities

• The successful candidate will drive, promote, and embed a culture of ethics, integrity, and continuous improvement focused on delivering efficiencies and maximizing CAMP4's platform, modulating gene expression by targeting regulatory RNAs.
• The role requires expertise in current Good Manufacturing Practice (cGMP), Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and relevant regulations across multiple jurisdictions.
• This involves engaging and collaborating with cross-functional internal teams to evaluate processes, procedures and activities for adherence to relevant industry standards, regulatory guidelines and company Standard Operating Procedures (SOPs) as appropriate.
• Accountable for overall quality and compliance oversight to include manufacturing, supply chain, nonclinical, and clinical functions, including conducting vendor audits and managing QP release in Europe.
• In collaboration with Clinical team, provides appropriate quality oversight of CROs.
• Ensures that appropriate quality criteria are built into the selection/implementation of, and upgrades to, electronic systems used to support any GXP-related activities.
• Ensures quality metrics comply with best industry standards and practices, and maintains effective quality governance and continually improves governance to meet organizational and compliance needs.
• Interprets and applies quality requirements and provides guidance and training to ensure that the company and its GxP vendors maintain an ongoing state of compliance.

Qualifications

• Bachelor's degree, preferably in the life sciences
• Ten years of relevant experience in GXP, QA leadership positions in a biotech and/or Pharmaceutical industry. Knowledge of nucleic acids, oligonucleotide-based therapeutics development is a plus
• Extensive knowledge and in-depth experience of implementation of Quality regulations in clinical, laboratory and pharmaceutical manufacturing environments
• Proactive in identifying opportunities with a strong solution-minded approach and flexibility to emerging challenges based on the scope and growth of the organization
• Strong collaborative, influencing, and interpersonal skills
• Excellent verbal, written, and presentation skills with the ability to deal effectively across all levels of management
• Ability to prioritize competing activities, manage resources, and budget accordingly