Director/Senior Director of Quality Assurance - Medical Device
Location: On-Site - South San Francisco
The Director/Senior Director of Quality Assurance - Medical Device directs and coordinates all quality assurance activities related to the device portion of a combination product. All candidates should have progressive leadership experience with developing quality systems, audit, and device verification. Activities will include developing, documenting, and maintaining technical business solutions or audits of data, policies, procedures, and systems to ensure compliance with 21 CFR 4 and the relevant part of Medical Device (21CFR 820s), ISO 13485, and ISO 14971-2 and other worldwide regulations related to combination products.
Specific areas of responsibility include, but are not limited to, design and oversee the Quality Systems related to oversight of the medical devices used in the delivery of the cell therapy to patients. This includes vendor audits, use-related risk assessments, oversight device verification, etc. This position interacts cross-functionally with the Cell Delivery, Translational Medicine, Operations, Regulatory, and Quality Assurance groups to ensure that all device areas are maintained in a state of control in accordance with applicable regulatory and compliance guidelines.
Responsibilities:
- Responsible for developing, reviewing and maintaining the quality systems related to the device of the combination product
- Manage and oversee corrective action teams and develop individual corrective action plans and systems
- Direct, manage, and oversee the activities of quality staff and personnel performing verification activities
- Prioritize quality engineering projects and assignments for completion by the appropriate QA personnel
- Responsible for the performance management and career development of direct reports and their subordinates.
- Analyze internal quality systems and associated data to assure adherence to QSRs, ISO, and other international standards
- Responsible for the investigation of product and process quality and manufacturing issues
- Perform periodic complaint trend analysis, make recommendations, and review associated action plans for complaint reduction
- Keep the leadership teams informed about quality-related problems and issues related to the device
- Participate in audits and prepare appropriate corrective action responses
- Ensure compliance with Good Manufacturing Practices (GMP and ISO), safety policies, and good housekeeping and that safety and hazard practices are understood and followed
- Build and maintain strong working relationships with site management and cross-functional departments, as well as external customers and regulatory agencies
- Generate quality plans, control plans, procedures, work instruction for overall quality and coordinate on effective implementation of such plans, procedures or instructions in compliance of regulatory requirements such as FDA, etc
- Maintain high-quality-assurance design services, engineering and manufacturing programs, standards and improvements within the organization
- Support Commercial team with customer interfaces where necessary on quality related issues, including quality escalation issues
- Serve as Device Quality SME during audits and regulatory inspections.
- Perform other duties as requested by supervisor/manager to support Quality.
- Work collaboratively with cross-functional teams, including manufacturing, research and development, and quality assurance, to support the overall quality of cell therapy products.
- Manage operational performance using key performance indicators.
- Promote a safe working environment, report potential hazards, and ensure all direct reports follow the Environmental Health and Safety procedures.
Required Qualifications:
- Bachelor's degree, preferably in engineering or technical discipline
- ASC CQE certification, preferred
- 10+ years' experience in engineering with progressive and extensive experience in medical device quality assurance
- Experience with Class II or Class III medical devices
- Knowledge of all phases of project management
- Expert working knowledge of ISO 13495, ISO 149702 and MDD
- Lean Six Sigma certification preferred
- Excellent analytical and statistical skills
- Excellent communications skills and a track record of accomplishment in leading and mentoring a subordinate team
- Minimum of 10 years of Quality experience in a GMP-regulated environment (device manufacturing strongly preferred; cell therapy, biologics is a plus).
- Strong, demonstrated knowledge of applicable regulations and guidance (EU GMP, ICH, FDA , etc.).
- Excellent organizational skills, with the ability to manage multiple priorities under GMP timelines.
- Strong leadership, mentoring, and team-building abilities.
- Exceptional technical writing, data analysis, and problem-solving skills.
- Effective communicator, capable of interacting with cross-functional teams and external auditors.
- Comfortable in a fast-paced, dynamic environment supporting clinical and commercial manufacturing.
- Adhere to cGMP policies and procedures, including documentation activities
- Able to wear appropriate personal protective equipment
- Able to work collaboratively to respond to changing priorities and challenges
- Communicate effectively with team members and contribute to a positive and collaborative work environment
- Actively participate in group and project teamwork, project and process improvements
Education Requirements:
- BA/BS degree in Microbiology, Biology, Chemistry, Engineering or related field and at least 10 years of Quality experience in a GMP-regulated environment.
