Position Overview : The Senior Director, Drug Product External Manufacturing Quality will ensure operational elements are developed and deployed in support of clinical and commercial operations within Cell Therapy.
He / She will ensure a consistent and global approach to operational oversight of Global Apheresis Network Onboarding and Maintenance and Contract Manufacturing Organizations (CMOs) in support of Cell Therapy operations.
REQUIRED COMPETENCIES : Knowledge, Skills, and Abilities : Education : Bachelor's degree in biochemistry, biology, microbiology, chemistry, engineering, pharmacy or related scientific discipline. Experience : REQUIRED
Minimum 13 years GMP-related industry experience with a minimum of 7+years' experience in quality assurance and 6+ years in a leadership / management role
Strong organizational skills, including ability to follow assignments through to completion
Advanced skills in leading, influencing, and negotiating
Advanced knowledge of relevant regulations and guidance; available to act as a resource for colleagues
Independent decision-making capability and ability to think conceptually and understand impact of decisions
Excellent verbal and written communication skills
Proven leadership and mentoring skills for junior staff
Ability to work effectively in cross-functional teams PREFERRED
Experience within the Cellular Therapeutics environment
Experience with Commercial Manufacturing of drug products
Ability to prioritize and successfully manage complex and competing projects
Strong written and verbal communication skills
Detail-oriented with expertise in problem solving and solid decision- making abilities
Ability to work in a fast-paced environment DUTIES AND RESPONSIBILITIES :
Lead and provide strategic direction group of staff with Global QA governance and operational oversight of CMO (intermediates and final drug product), product warehouses and patient operations (scheduling and apheresis Quality Vendor Management)
Help build and ensure approved quality systems and quality business processes are developed and established to meet the business needs for Patient Operations and CMO work while maintaining to BMS's quality standards and regulatory requirements
Responsible for Quality leadership oversight of manufacturing / warehouse operations and to ensure work is performed in accordance with approved regulatory submissions, technical agreements and applicable regulatory requirements
Assist with compliance inspections, and in developing remediation efforts and responses when necessary. Recognize opportunities for improvement, driving CAPA and / or change control internally and in relation to CMO functions.
BMSCART Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.