Quality Responsible Person Greece

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.

Bristol Myers Squibb is a leading global biopharma company focused on discovering, developing and delivering innovative medicines for patients with serious diseases in areas including oncology, haematology, immunology, cardiovascular and neuroscience. Our employees work every day to transform patients’ lives through science.

The Role

We are now recruiting a Quality Responsible Person Greece, who will ensure that a Quality Management System is implemented and maintained in the local market, including:.

Key Responsibilities and Major Duties:

• Acts as the local Qualified Person responsible for GDP in accordance with Market regulatory requirements
• Maintains Quality System Documentation: procedures and records
• BMS Policy/Directives/SOPs impact assessment and implementation
• GDP and Local regulations impact assessment and implementation
• Ensures initial and continuous GMP/GDP training programs are implemented and maintained, including product identification and avoidance of falsified
• Develops and maintains locally the Quality Manual
• Ensures that relevant customer complaints are dealt with effectively
• Performs periodic Self-inspections according with the self-inspection plan and puts in place necessary corrective measures
• Ensures implementation of Deviation and CAPA management
• Ensures implementation of the Change Control management
• Reviews the APQRs, as required per local regulations
• Leads the Quality Management Review/Quality Council of the Market
• Reports quality metrics

Ensures implementation of following Quality Operations:

• Suppliers management oversight: Quality Agreements, approving any local subcontracted activity which may impacts product quality, evaluate and confirm the overview of the supplier qualification status
• Customers oversight: periodic customer License verification
• Product Quality status and batch release or approval to the market
• Local QC testing, CoA review and local release, when applicable
• Analytical transfer coordination/approval to meet product launch, when applicable
• Support compliance/quality issues with the impacted market team
• Attends the market action fact finding meetings when required and implements the defined action plans within market
• Ensures On Hold products request are observed
• Coordinates and promptly perform any market action operation, recall, for medicinal products. Mock recalls
• Decides on the final disposition of rejected, recalled or falsified products
• Approval of the returns to saleable stock, according to BMS requirements
• Support Supply Chain to avoid Back Orders
• Provide quality input on shortage situations and oversight reporting to Health Authority
• Medical samples Quality distribution oversight
• Supports of sampling requested by HA (product, procedures, reference substances)
• Keeps appropriate records of any delegated duties

Facilitate that BMS requirements are implemented in the Local Distribution Centre for:

• Warehousing facilities
• Secondary packaging facilities
• Transportation processes

Quality Risk Management

• Coordination and preparation of Quality Risk Management
• Participate in the periodic Business Review with the DC

Inspections and Regulatory Surveillance

• Maintenance of the Wholesale Distributor License with Regulatory agency
• Import certificates, when requested
• Support the Global Quality Audits in the market
• Preparation of HA inspection in local entity and leading HA inspection
• Anticipate the new directives (Regulatory surveillance)

Expected area of competence:

• Ensures the implementation and maintenance of quality management system, for the distribution activities with BMS product in the Market.
• Attendance to complex issues impacting the market.
• Identifies and communicates quality issues and decisions, which impact the business.
• Ensures 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.

Experience and Knowledge:

• Bachelor's degree in Sciences, preferably in Pharmacy
• 5 years of progressive experience within the quality function of the pharmaceutical health care industry
• 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 and Speed
• 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 SAP) 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.
• Negotiating skills for interfacing with Health Authorities and market business functions.
• Ability to effectively communicate ideas and influence others to accomplish challenging goals and objectives.

What’s important to us

Employees are expected to display the BMS Values, which move us toward our mission to discover, develop and deliver innovative medicines that help patients prevail over serious diseases:

Passion: Our dedication to learning and excellence helps us to deliver exceptional results.

Innovation: We pursue disruptive and bold solutions for patients.

Urgency: We move together with speed and quality because patients are waiting.

Accountability: We all own BMS’ success and strive to be transparent and deliver on our commitments.

Integrity: We demonstrate ethics, integrity, and quality in everything we do for patients, customers, and colleagues.

Inclusion: We embrace diversity and foster an environment where we can all work together at our full potential.

We have a passion for tackling the toughest diseases, which inspires innovation and speed in our daily work and a sense of accountability to the patients we serve.

#LI - ONSITE

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.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

BMS is dedicated to ensuring that people with disabilities can perform complex functions through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.