The Quality Assurance Manager is primarily responsible for ensuring that the stem cell production facility, process, equipment and analytical instruments are validated and maintained in accordance with all cGMP standards, internal policies and best practices within the industry. The ideal candidate is a critical thinker who will proactively improve the qulity systems of the company through internal audits, participation in process improvement programs, and interaction with key partners to obtain constructive feedback.
Duties and Responsibilities:
- Develop and maintain overall validation program including facilities, utilities, equipment, analytical instruments, process and site-specific computerized systems
- Write, review and approve qualification documents to support process validation activities
- Direct validation activities to support cGMP manufacturing
- Proactively conceptualize and establish validation approaches to enhance and optimize current processes
- Prepares SOPs, logs, labels, forms etc. that conform to U.S. FDA requirements
- Create training programs and ensures that technician training is up-to-date
- Performs regular audits and mock inspections
- Plans and directs all facility accreditations
- Ensures facility and process compliance with all applicable local, state and federal regulatory agencies
- Responsible for CMC portion of any IND application
- Provide hands on support to the manufacturing and quality control areas as required to assist in problem solving and product/process improvements.
- Forecast and manage costs and staffing needs
- BA/BS in a scientific or engineering related field
- 5+ years work experience in quality and validation with a strong understanding of GMP and FDA regulations
- Preferably has experience with direct validation responsibilities in cell therapies
- Experience managing internally as well as contracting services
- Experience on new facility startup and/or facility conversion is desirable
- Experience supporting FDA approved, commercial products is desirable
Essential Skills and Abilities
- Excellent written and verbal communication skills at all levels.
- Excellent leadership skills
- Can take direction well
- Can multi-task
- Can quickly adapt to different circumstances
- Team player
- Must have integrity and most importantly, passionate about their work
Hope Biosciences is a clinical stage biotechnology company based out of Sugar Land, Texas that is focused on the development of adult stem cell therapeutics for the treatment of incurable conditions.
This is an opportunity to work with a highly motivated and passionate team that is focused on a common goal: to improve patient’s lives. We are actively seeking individuals who are enthusiastic and can fit into our company culture. We offer competitive pay, excellent benefits and a chance to help build a company that is positioned to lead the future in cellular therapeutics.
For more information, please visit: www.hope.bio