What are the responsibilities and job description for the Director of Quality Assurance position at CAMP4 Therapeutics?
Position Title: Director of Quality Assurance
Location: Cambridge, MA
Reports To: SVP of Technical Operations
Join the Adventure!
CAMP4 Therapeutics is seeking a Director of Quality Assurance. The Director, Quality Assurance is responsible for the strategic development and execution of CAMP4s quality assurance programs including all quality-related decisions. This person will be reporting into the SVP of Technical Operations with CAMP4.
Title commensurate with experience.
What You Will Do
Founded in 2016 and focused on a core mission of realizing a world with ‘an effective treatment option for every patient,’ CAMP4 Therapeutics evolved from seminal discoveries made by company founders Dr. Richard Young and Dr. Leonard Zon, characterizing the ways in which cellular machinery controls the expression of genes. Operating at the intersection of genomics, computational biology and data sciences, CAMP4 has extended this foundational work, creating a unique platform to amplify the value of cellular and genetic insights to better understand how gene expression is controlled within the nucleus in specific disease states. Using next-gen sequencing and proprietary methods, CAMP4 can identify de-risked druggable targets, produce actionable insights and improve therapeutic predictability, potentially addressing hundreds of diseases and benefiting millions of patients globally. We sit at the intersection of technological innovation, emerging insight into basic gene control, and scientific ingenuity — uniquely positioned to build a self-sustaining, always innovating biotech company.
Find out more at www.camp4tx.com
Location: Cambridge, MA
Reports To: SVP of Technical Operations
Join the Adventure!
CAMP4 Therapeutics is seeking a Director of Quality Assurance. The Director, Quality Assurance is responsible for the strategic development and execution of CAMP4s quality assurance programs including all quality-related decisions. This person will be reporting into the SVP of Technical Operations with CAMP4.
Title commensurate with experience.
What You Will Do
- The successful candidate will drive, promote, and embed a culture of ethics, integrity, and continuous improvement focused on delivering efficiencies and maximizing CAMP4s 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
- Est
- 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 company and its GxP vendors maintain an ongoing state of compliance
- 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
Founded in 2016 and focused on a core mission of realizing a world with ‘an effective treatment option for every patient,’ CAMP4 Therapeutics evolved from seminal discoveries made by company founders Dr. Richard Young and Dr. Leonard Zon, characterizing the ways in which cellular machinery controls the expression of genes. Operating at the intersection of genomics, computational biology and data sciences, CAMP4 has extended this foundational work, creating a unique platform to amplify the value of cellular and genetic insights to better understand how gene expression is controlled within the nucleus in specific disease states. Using next-gen sequencing and proprietary methods, CAMP4 can identify de-risked druggable targets, produce actionable insights and improve therapeutic predictability, potentially addressing hundreds of diseases and benefiting millions of patients globally. We sit at the intersection of technological innovation, emerging insight into basic gene control, and scientific ingenuity — uniquely positioned to build a self-sustaining, always innovating biotech company.
Find out more at www.camp4tx.com