Manager Quality Operations, Delegate Rp/fvp - Boudry, Schweiz - Bristol Myers Squibb

Bristol Myers Squibb

Geprüftes Unternehmen

Boudry, Schweiz

vor 2 Wochen

Geschrieben von:

Lena Schneider

beBee Recruiter

Beschreibung

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.

Summary

The 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 nonreadytouse and readytouse medicinal products in accordance with the Swiss law on Medicinal Products.
Pharmaceutical Inspection Cooperation 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
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
Previous experience as Responsible Person (FvP), including handson 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
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)

Uniquely Interesting Work, Life-changing Careers

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 collabo