ArsenalBio’s mission is to develop efficacious and safe cellular therapies for patients with chronic diseases, initially cancer. Our products are being designed to herald the transition of adoptive cell therapy from a hospital based treatment to outpatient therapy, like most other cancer treatments.
Our people are our greatest asset, they bring scientific talents in molecular biology, immunology, pharmacology, protein chemistry, computational biology, automation, genome engineering, software and other fields to make the future happen now.
We are seeking a talented and motivated Director/Senior Director to join the ArsenalBio Technical Operations team and lead the establishment of Quality systems, documentation standards, document control operations and management, and training. The individual will develop the vision and implement the strategy for the ArsenalBio’s Quality team in instituting and maintaining training and submission/revision/approval of technical documents associated with clinical manufacturing and collaboration with external partners/vendors. The individual will lead the installation, roll out, and management of ArsenalBio’s Quality Management System for the greater organization. The position will interact cross-functionally across the organization to enable the success of ArsenalBio.
What you will do:
- Lead the roll out and management of Quality Management System; ensure the QMS evolves with the appropriate clinical phase of development
- Build and manage a Quality Systems team that will support authoring and revision of quality system procedures, specifications, SOPs, work instructions, manufacturing batch records and forms, performing document processing and records handling; accurate data entry into databases, as required.
- Work with senior management to integrate quality risk management concepts and philosophies into the overall Quality SystemAuthor quality standards and standard operating procedures, as needed.
- Review documents for accuracy, completeness, and compliance. Identify and implement changes needed for existing documentation processes to support continuous improvement
- Serve as a change agent, training colleagues and providing understanding of document control and records management practices and training, ensuring compliance of these practices across the organization
- Develop the overall team strategy and framework development for new and emerging initiativesManage junior team members Establish processes for accurately tracking, reporting, and analyzing metrics, as required.
- Lead the training on documentation standards and document change controls as related to GxP documentation and product documents.
- Lead high-performing teams focused on initiatives on general documentation standards, quality knowledge management and Quality System / Product Documentation improvements.
- Perform Quality audits and technical visits as needed
What you will bring:
- BS degree in relevant scientific field or discipline
- 12+ years experience and strong background in Quality and document control in the drug development industry with knowledge of cGMP/ICH/FDA/EMA regulations
- 5+ years experience leading and developing teams
- Prior experience in QA or QC, document management for cell therapy products preferred with particular focus on administering electronic document management systemsDemonstrate a quality mindset and ability to influence across the organization
- Demonstrated analytical and critical thinking skills, issue resolution skills
- Successful experience writing and reviewing SOPs and other Quality documentsExpert knowledge of phase appropriate cGxPs and experience leading Quality System implementation and continuous improvement efforts.
- Direct experience with quality investigations, assessments, reviews and/or evaluations of Quality events (CAPAs, deviations, change control, document control, etc.)
- Team player with the ability to work in a collaborative, fast-paced team environment
- Strong written and verbal communication skills and experience with working in cross-functional teams
- Proven leadership skills and strategic problem-solving ability; able foresee issues and identify solutions with a flexible mindset
- Excellent problem-solving skills and experience with root cause investigations and CAPA determination
- Ability to lead successfully within extended project teams and handle multiple challenges under pressure
- Excellent organizational skills: Proactive, management of multiple tasks of varying complexity simultaneously
- Experience with Veeva electronic quality management system is a plus.
We are committed to hiring the best talent. A diverse workforce engenders richness of thought, creativity and discovery. We invite individuals who embrace intellectual achievement to bring their unique personal and professional journeys and together we will build transformative cell therapies for cancer patients.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
To all recruitment agencies: ArsenalBio does not accept agency resumes. Please do not forward resumes to our jobs alias, or Arsenalbio employees. ArsenalBio is not responsible for any fees related to unsolicited resumes.