In-Market Quality Manager

at  BristolMyers Squibb

WORKING WITH US

Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
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. Read more: careers.bms.com/working-with-us .

REQUIREMENTS

Expected area of competence:

• Attendance to complex issues impacting the market.
• Identifies and communicates quality issues and decisions, which impact the business.
• Supports to ensure compliance of market Third Party Distribution partners to BMS Quality requirements related to distribution and transportation.
• Embraces continuous improvement activities for more effective Quality systems across the organization.

Competencies - knowledge, skills, abilities, other:

• Must possess a master’s degree in pharmacy
• Ability to develop and apply BMS operating philosophy and to operate within Company policies and procedures within Quality and Compliance area.
• Ability to apply BMS BioPharma Behaviors required: Passion, Innovation, Accountability, Integrity, Inclusion and Urgency
• Good verbal, written and presentation skills in English.
• Innovative, creative and utilize available resources.
• Strong working knowledge in PCs (experienced in Excel, Word, PowerPoint) and in Quality Systems
• Team oriented worker with excellent interpersonal skills.
• Ability to actively participate in projects within a multi-disciplinary environment, inquisitive, science technology oriented individual but practical.
• Ability to collaborate and communicate directly and to actively participate in cross-functional and cross regional teams.
• Ability to effectively communicate ideas and influence others to accomplish challenging goals and objectives.
• 1-2 years of progressive experience within the quality function of the pharmaceutical health care industry.
• Knowledge and experience in pharmaceutical health care operations, quality control, distribution and International regulations are essential.
• Proficient in GDPs and regulations promulgated by the FDA, EMA or equivalent regulatory Agencies; ISO 9001:2000 regulations; and requirements for pharmaceutical products distribution.

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Ensure that a Quality Management System is implemented and maintained in the local market, including:

• Supports and maintains Quality System Documentation: procedures and records
• BMS Policy/Directives/SOPs impact assessment and implementation
• GDP and Local regulations impact assessment and implementation
• Supports initial and continuous GMP/GDP training programs are implemented and maintained, including product identification and avoidance of falsified
• Supports update to and maintenance of the Quality Manual(s)
• Ensures that relevant customer complaints are dealt with effectively
• Supports the periodic Self-inspections according with the self-inspection plan and puts in place necessary corrective measures
• Supports implementation of Deviation and CAPA management
• Supports implementation of the Change Control management
• Supports the preparation of the Quality Management Review/Quality Council of the Market
• Ensures implementation of following Quality Operations:
• Support Suppliers management oversight
• Support Customers oversight
• Support Responsible Person and back-up Responsible Person with Product Quality status and/or approval to the market
• Support compliance/quality issues with the impacted market team
• Support coordination and promptly perform any market action operation, recall, for medicinal products and mock recalls
• Supports implementation of BMS requirements in the Local Distribution Centers for:
• Warehousing facilities
• Transportation processes
• Quality Risk Management
• Support coordination and preparation of Quality Risk Management
• Inspections and Regulatory Surveillance
• Support the Global Quality Audits in the market
• Supports preparation of HA inspection in local entity and leading HA inspection
• Anticipate the new directives (Regulatory surveillance)