Head of Quality Assurance
Proclinical is currently working with a clinical-stage gene therapy company located remotely, in search for a Head of Quality Assurance. As the Head of QA, you will be responsible for strengthening, further development and execution of the quality assurance program and management systems, in support of all clinical development, pharmacovigilance, supply chain and manufacturing activities.
- Ensure company Quality Management System meets standards expected by US and global regulatory authorities for research, development and ultimately commercial activities
- Work closely with stakeholders to drive compliance with GxP regulations from Sponsor perspective
- Write, review and revise SOPs related to clinical trials according to applicable global GxP regulations
- Manages and supports internal audits of GxP functions and serve as a champion for continuous improvement in all aspects of total quality management through a well-trained team, streamlined business processes, and appropriate structured quality operations
- Ensure products manufactured at CDMOs meet company quality standards and government regulations
- Counsel, train and interpret quality requirements to ensure we and our GxP vendors maintain a state of compliance
- Communicate significant quality risks that may impact product suitability or regulatory compliance in a timely manner to Executive Management
- Serve as an escalation point for corporate quality issues
- Serve as primary Quality contact in any audit by a regulatory authority and lead all audit communications with audit personnel from a regulatory agency
- In collaboration with key stakeholders (Operations), provide both strategic and tactical Quality input and decisions related to innovative technologies, industry best practices, new regulations, and processes in end-to-end supply chain operations
- Responsible for championing a partnership/customer focus approach in the organization ensuring all functions view the quality organization as a proactive collaborator and partner to ensure effective, safe, and compliant achievement of company goals
Skills and Requirements:
- Bachelor's degree or advanced degree in related Life Sciences discipline
- 15+ years of relevant experience in GxP, QA management or QA leadership positions in a Biotech or Pharmaceutical setting
- Strong understanding of US FDA and EU EMA regulations and ICH guidelines for GMP manufacturing of cell and gene therapy products
- Fundamental knowledge of US, EU and international regulatory standards and guidelines for the conduct of clinical trials
- Experience interacting with regulatory health authorities at pre- and post-approval inspections
- Strong analytical skills and report writing skills
- Demonstrated team leadership and staff management and development experience
- Must have professional communications skills, strong independent time management skills and the ability to manage multiple projects concurrently
- Excellent communication, negotiation, and presentation skills
If you are having difficulty in applying or if you have any questions, please contact Christian Delbaere at (+1) 647-227-1672 or firstname.lastname@example.org.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.