Quality Systems Associate Manager/Manager
This position will primarily be responsible for Supplier Qualification and Management, External and Internal Audits, as well as inspection support. Additionally, this position will support other Quality Systems processes such as Document Control, Quality Records Management, Training, Deviations and CAPA, Change Control, Complaint handling, and Quality Management Review reporting. Responsibilities
- Manage the Dynavax Supplier Management Program, including but not limited to qualification, periodic evaluation and/or requalification of new and/or existing Suppliers and Service Providers.
- Generate and manage the annual External and Internal Audit schedules employing a risk-based approach.
- Support the Quality team during regulatory inspections.
- Manage related components of the electronic Quality Management System (eQMS).
- Maintain records and generate reports for Quality management review.
- Provide information for annual product reviews.
- Maintain a work environment focused on quality and that fosters learning, respect, open communication, collaboration, integration, and teamwork
- This position will involve occasional travel.
- A BA/BS in life science or related field and 5+ years’ of quality experience in the pharmaceutical industry, or equivalent combination of education and experience. For the Associate Manager level, at least 1 year of supervisory/management experience is highly desirable. The Manager position requires at least 3 years’ management experience.
- Knowledge of GMP requirements for biologics or pharmaceuticals and experience with Quality Systems.
- Strong technical writing and editing skills.
- Must be an effective communicator with proven abilities to deliver complex information and concepts with clarity.
- Must possess a flexible approach to problem-solving, be an adept negotiator, and be able to effectively troubleshoot problems and issues.
- Proven ability to establish collaborative working relationships with internal and external stakeholders; strong team orientation and the ability to work independently.
- Strong organizational skills with the ability to effectively prioritize, manage multiple projects and tasks, and have great attention to detail.
- The ideal candidate is highly ethical, flexible, action- and goal-oriented, works well under pressure, and is effective in meeting committed deadlines.
- The incumbent in this position must be able to remain in a stationary position for periods up to 50%. The person in this role needs to occasionally move about the office for meetings and to access files and other office records/materials.