The Director, QA is responsible for development, oversight, and execution of various quality assurance activities. This is an opportunity to lead and build the foundation for the QA function at OncoMyx as it relates to clinical and manufacturing activities for early development through to clinical studies. This position leads the organization and program elements of the company’s quality assurance, validation, and compliance functions. The Director, QA is responsible for establishing and overseeing the Quality Management System (QMS), for manufacturing (cGMP) and clinical (GCP) functions.
Location: Phoenix or virtual with ability to travel up to 30%
Essential Duties and Responsibilities
Qualified candidates will possess the following skills and experience.
- Responsible for the development, implementation and maintenance of the QMS for cGMP and GCP.
- Periodically provides reports on the performance of the QMS along with recommendations for improvement.
- Develops Standard Operating Procedures (SOPs), guidelines, standards and records.
- Understands practical applications of GMP phased approach and a risk bases Quality approach; create and update existing procedural documents to incorporate these approaches.
- Process owner or QA reviewer for change controls of SOPs, specifications, validations, and forms related to QA activities; ensure Change Control activities are well documented; follow up on open Change Controls and assess impact of changes on validation and key systems.
- QA review and approval of Master Production documents and/or Batch records.
- Perform or assist in internal and external audits for vendors and clinical sites; write internal audit reports and follow-up on completion of any open corrections or corrective actions deemed necessary that were communicated and documented to the auditee.
- Ensure adequacy of procedures for phase appropriate cGMP compliance; must be able to identify deficiencies and discrepancies during internal audits, walk-through, for cause or impromptu audits and documentation audits; ensure management is notified and actions are taken to correct/address the quality problem(s) in a timely manner.
- Perform or assist in Vendor Evaluation and Performance.
- Exercises sound judgment in addressing and proactively managing business issues with minimal direction and supervision.
- Build and supervise QA team as necessary to accommodate company growth and phase of product development.
Education and Qualifications Requirements
- Bachelor’s degree in a scientific discipline
- 7+ years in a GMP/GCP biotechnology or pharmaceutical environment
- 4+ years in QA leadership
- Experience working directly with the FDA or other regulatory agencies
- Experience leading/building QA function in small company and/or start up environments
- Experience leading a QA function specifically for biologics or oncolytic viruses (preferred)
- Ability to lead collaboratively and build trusting relationships in a cross functional environment
- Effectively communicate expertise, how it related to subject matter area and processes while seeing the big picture
- Pro-active team player, no task is too small if it has a positive impact on the science and company
- Proven ability to work productively in a virtual/on-site hybrid working environment