Bristol Myers Squibb Quality Responsible Person Switzerland in Cham, Switzerland
One shared journey moves us forward. Bristol-Myers Squibb is a BioPharma leader offering opportunities to learn and grow professionally, working alongside smart, talented colleagues who are committed to helping patients prevail over serious diseases.
Our medicines help millions of people around the world in their fight against cancer, heart disease, HCV, and rheumatoid arthritis. Our commitment to patients’ unmet medical needs drives innovation and pride in our record of achievement and we are recognized as having one of the most innovative pipelines in the industry with launches in Oncology and Specialty products.
The Quality Responsible Person Switzerland is responsible for ensuring that a quality management system is implemented and maintained for the distribution activities with BMS products in the Market.
Expected area of competence:
• Leads the implementation and oversee the quality management system, including the organization and the documentation and tracking of the completion milestones.
• Deals with complex issues using critical analysis and develops ethical, reasoned solutions to meet both business and regulatory requirements.
• Impacts and influences the organization by communicating quality issues and decisions which impact the business.
• Ensures compliance of Third Party Distribution suppliers with all BMS requirements related to distribution and transportation.
• Ensures continuous improvement activities for an effective quality management systems across the Cluster.
Ensure that a Quality Management System (QMS) is implemented and maintained in the local entity in Switzerland including:
Act as the Responsible Person Switzerland (based on AMBV Art. 7-11, fachtechnische verantwortliche Person Art. 10)
Has the authority to give directives in business operating area to all employees
Maintain the QMS Documentation: procedures and records, BMS Policy/Directives/SOPs &WI, GMP/GDP and Local regulations impact assessment and implementation
Training of personnel: initial and continuous training programs are implemented and maintained, including product identification and avoidance of falsified products
Develop and maintain the local Quality Manual
Ensure that customer complaints are dealt with effectively
Performing Self-inspections at appropriate regular intervals following a prearranged program and necessary corrective measures are put in place
Implement and maintain a System to investigate Deviation and to manage CAPA
Implement and maintain a Change Control management system
Review the APQRs
Lead the Quality Council of the local affiliate and issue the quality management review
Implement adequate action plans for metrics achievement when necessary
Competences in Quality Operations:
Manage the system for suppliers management: Quality Agreements, approving any subcontracted activities which may impact on the product quality
Manage the system for customers approval: Licenses
Handle compliance/quality issues with the impacted local affiliate team, within the global networks of Quality Assurance
Attend the fact finding when required and define the adequate action plans with In market
Ensure On Hold products request are observed
Coordinating and promptly performing any recall operations for medicinal products. Perform Mock recalls as needed
Decision on the final disposition of rejected, recalled or falsified products
Approval the returns to saleable stock, according to BMS guidelines
Support Supply Chain to avoid Back Orders
Provide quality input on shortage situations and oversight reporting to the Health Authority
Medical samples Quality distribution oversight
Keeping appropriate records of any delegated duties
Facilitate BMS requirements are implemented in the Local Distribution Centre (DC) for:
Secondary packaging facilities (when required to be used for exceptional operations)
Quality Risk Management
Coordination and preparation of Quality Risk Management
Participate in the periodic Business Review with the local DC
Inspections and Regulatory Surveillance
Maintaining the Wholesale Distributor License with Regulatory agencies
Preparation of HA inspection in local entity and leading in HA inspection (as required)
Support the Global Quality Audits in the market
Must possess a Bachelor’s degree in Sciences, preferably in Pharmacy
5-7 years of progressive managerial experience within the quality function of the pharmaceutical health care industry and regulatory agencies.
Demonstrated ability to develop and apply BMS behaviors and to operate within Company policies and procedures related to Quality and Compliance area
Demonstrate ability to switch priorities plus manage more than one project at a time. Ability to plan and conduct projects within a multi-disciplinary environment, inquisitive, science technology oriented individual but practical.
Demonstrated ability to influence, collaborate and communicate directly and to lead cross functional and cross regional teams.
Extensive knowledge and experience in pharmaceutical health care operations, quality assurance and control, distribution and International regulations are essential.
Proficient in GMPs, GDPs and regulations issued by Swissmedic, EMA or equivalent regulatory Agencies; and requirements for pharmaceutical products distribution.
Good verbal, written and presentation skills in English; the ability to deal effectively with all levels of management.
Innovative, creative and utilize available resources.
Team oriented worker with excellent interpersonal skills.
Strong negotiating skills for interface with regulators and external Quality Assurance business. Demonstrated ability to effectively communicate ideas, lead and persuade others to accomplish challenging goals and objectives.
Understanding of the drug development process from discovery to marketing
Highly developed conceptual and analytical skills
Strong working knowledge in PCs (experienced in Excel, Word, PowerPoint, outlook and SAP) and in Quality Systems
BMS BioPharma Behaviors required
Passion: We pursue excellence to help patients prevail. I set high standards for myself and others to win for our patients / I energize others / I strive to learn something new every day / I treat my patients, customers and colleagues with compassion, empathy and respect.
Innovation: We embrace new ideas. I challenge the status quo / I seek and share bold idea that help BMS win / I pursue and understand diverse perspectives outside of BMS / I encourage and have constructive debates / I embrace change to drive innovative outcomes / I rebound quickly and learn from my mistakes.
Accountability: We own our outcomes and the outcomes of others. I own BMS Success by holding myself and others accountable / I share information in a transparent and honest way / I celebrate my successes and the successes of others / I coach and mentor others with good intent and purpose / I am inclusive and bring out the best in others / I understand what people do and the impact I have on them.
Speed: We act with urgency and agility. I work with a sense of urgency / I focus on what’s important / I consult with the right people to move quickly / I seek efficient, effective solutions / I quickly assess potential risks and rewards / I break silos and eliminate unnecessary rules / I make decisions with resolve and enable others to do the same.
We’re creating innovative medicines for patients fighting serious diseases. We’re also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled