Manager Quality Operations, Delegate RP/FvP

Conteúdo do emprego

Working with UsChallenging. 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.SummaryThe Manager Quality Operations, Delegate RP/FvP will be responsible to support the Responsible Person (RP)/ Fachtechnisch verantwortliche Person (FvP) for the direct supervision, maintenance and continuous development of the Quality Management System in order to ensure that the manufacturing and trading operations are performed in compliance with Swiss and international guidelines on current Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP), thus ensuring the safety, efficacy and quality of the medicinal products, and that non-ready-to-use and ready-to-use medicinal products are manufactured and/or traded in a safe manner.Responsibilities

• Ensure that the medicinal products meet the specifications in force and are being manufactured in accordance with Good Manufacturing Practice (GMP) as well as transported in accordance with Good Distribution Practice (GDP) requirements
• Perform supplier and customer bona fide checks to ensure that all parties involved in the manufacture, supply, storage or distribution of the medicinal products are authorized to carry out the operations that they perform
• Oversee and manage supplier related activities to ensure that direct materials and associated suppliers are and remain qualified
• Author and review SOPs and other controlled documents in conjunction with the technical/ GMP batch release of the medicinal products and in the area of responsibility
• Act as Delegate RP/FvP for Manufacturing and Trade Abroad of non-ready-to-use and ready-to-use medicinal products in accordance with the Swiss law on Medicinal Products.
• Pharmaceutical Inspection Co-operation Scheme (PIC/S)
• Raise, manage and/or investigate deviations from established procedures, products or transport activities to ensure they are documented and investigated, and appropriate corrective and preventive actions (CAPAs) are implemented in line with the principles of quality risk management
• Apply Quality Risk Management principles for the assessment, control, communication and review of risks to the quality of the manufactured and traded products; perform risk assessments and manage risk register as required
• Support the coordination and execution of any recall operations for medicinal products under GCH oversight
• Support local Health Authority Inspections and Global BMS Audits including their preparation and coordination; support related follow up activities and supervise CAPA implementation in collaboration with the RP/FvP
• Support qualification/validation activities involving GCH GMP/GDP operations, systems or software
• Approve redeployments and direct shipments
• Author, review and manage quality agreements with third parties or internal sites, including, but not limited to, manufacturing, testing, release, storage, and transportation services
• Report quality issues and any suspicion of illegal trading to RP/FvP and support the notification of Swissmedic according the applicable requirements and within the stipulated deadlines
• Maintain and continuously improve the companies’ Quality Management System in the area of responsibility in order to ensure compliance with the legal requirements at any time
• Has the authority to issue directives within the area of responsibilities
• Participate regularly in a course, seminar, congress or the like with focus on GMP/GDP topics regarding regulatory requirements, trends and industry standards as part of the continuous professional development

Required Qualifications And Experience

• Master’s or higher degree in Pharmacy, Chemistry, Biology, Chemical/ Bio Engineering or equivalent
• Minimum of 5 years’ experience in the pharmaceutical industry, with solid quality and compliance experience
• Experience in the application of pharmaceutical Quality Systems and Quality Assurance including solid knowledge of cGMP (EU and US), GDP, ICH and other quality guidelines and standards, and ability to interpret and apply them during daily work
• Previous experience as Responsible Person (FvP), including hands-on experience in batch review and release is preferred but not mandatory
• Technical expertise in conducting investigations, developing effective CAPA and use of risk assessment techniques
• Experience in applying Quality Risk Management principles and tools
• Strong interpersonal, communication (both verbally and in writing), collaborative and leadership skills in a matrix organization and in a variety of cultures
• Fluency in English, German is a plus.
• Experience working with SAP, TrackWise, Veeva and electronic Document Management Systems
• Very good computer literacy (Microsoft Outlook, Word, Excel, PowerPoint)

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 CareersWith 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 ProtocolPhysical 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.