Senior Manager, Good Distribution Practices (Gdp) Quality > Joboolo CH :
Company : Bristol Myers Squibb Location : Boudry Neuchâtel From : Neuvoo CH
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Position summary:
The Cell Therapy Quality GDP is responsible for the oversight of end-to-end GoodDistributionPractices(GDP) processes for clinical and commercial Cell Therapy (CT) materials to ensure compliance with GDP as well as current Good Manufacturing Practice (cGMP) guidelines per their assigned region.
This spans raw materials through finished products and includes oversight over third party suppliers of transport and storage services.
This position is critical to ensure the safety, efficacy, and quality of the BMS Cell Therapy products.
This role ensures compliance with all relevant national and international GDP and GMP regulations issued by the relevant authorities as well as with BMS internal guidelines and its Quality Management System (QMS) Key Responsibilities:
- Establish, develop and maintain the global Quality processes to comply with Cell Therapy GDP requirements from major regulatory bodies and institutions, e.G.
o U.S.
FDA o EMA o PMDA o Swissmedic o Pharmaceutical Inspection Co-operation Scheme (PIC/S) - Establish such GDP Quality processes in close collaboration with relevant CT and global stakeholders, e.G.
- Embed such GDP Quality processes into the companies’ global Quality Management System in order to ensure compliance with the legal requirements.
- Ensure that Third Party Service Providers own required license(s) authorizing them to carry out the respective business operations.
- Establish, develop and maintain seamless processes for end-to-end storage, transport & logistics deviation management, i.E.
from raw materials to finished product.
- Establish, develop and maintain seamless processes for end-to-end storage, transport & logistics change management, i.E.
from raw materials to finished product.
- Establish, develop and maintain seamless Quality oversight processes for the management of Chain Of Identity (COI) and product labelling.
- Ensure new regulatory GDP requirements are identified and associated changes implemented.
- Ensure that any additional requirements imposed on certain products by national laws are adhered to.
- Support qualification/validation activities involving GDP/transport/ storage operations, systems or software.
- Ensure and keep records to prove that the approved conditions during transport and storage of the CT products as stated on the packaging (label) are maintained.
- Support decisions on disposition of returned, rejected, recalled or falsified products as required.
- Establish, implement and maintain a GDP training program for personnel involved in GDP/cGMP activities.
- Support GDP related topics as a Subject Matter Expert (SME) during Health Authority inspections and audits globally.
- Establish GDP metrics and KPIs to review the effectiveness of relevant processes and the performance of Third Party Service Providers.
- Establish and maintain appropriate GDP language in relevant BMS Quality Agreements.
- Ensure that a Quality Risk Management process is in place for the assessment, control, communication, and review of potential GDP risks to the CT product quality.
- Ensure that product complaints are properly investigated.
- Support as an SME Notifications to Management (NTM) and other escalation procedures.
- Lead and/or participate in projects involving GDP matters.
- Participate in visits at Third Party Service Providers, e.G.
for due diligence, operational review meetings.
Qualifications & Experience:
- BS or equivalent education in Science, or related fields.
- 5-9 of experience in a related industry experience with a minimum of 5 years of experience in vendor/supplier quality oversight.
- Experience with clinical and commercial biotechnological and/or cell & gene therapy pharmaceutical products preferred.
- Experience in the application of pharmaceutical Quality Systems and Quality Assurance including solid knowledge of GDP and cGMP (US, EU, JP, ICH) quality guidelines and standards, and ability to interpret and apply them during daily work.
- Technical expertise in conducting investigations, developing effective CAPA and use of risk assessment techniques.
- Hands-on experience in interacting and effectively communicating with Third Party Service Providers.
- Experience to act as a SME during Health Authority inspectionsRequired competencies:
Skills, knowledge, and abilities:
- Thorough knowledge of cGDP in the pharma/Biotech industry as well as FDA, EU, and JP regulatory requirements, PIC/S and ICH guidelines.
- Knowledge of cold chain logistics is preferred.
- Experience with performing/participating in risk assessment exercises.
- Experience in logistic and warehouse vendor oversight.
- Thorough knowledge of and competence in core quality processes - including change control, deviations/OOS, CAPA management, investigations, APR-PQR.
- Excellent investigational and QA problem solving skills – e.G. - Able to interpret problems and effectively prepare surrounding communication in a productive manner to management and the group with clarity, brevity, and accuracy. - Able to recognize and group technical/scientific attributes and drive science-based decisions in most technical areas and to a deeper level in the specific job function. - Must have strong authorship and be able to critically review investigations, interpret results, and generate technical conclusions consistent with Quality risk management principles.
- Analytical mindset – e.G. - Able to assess vendors quality core processes to ensure compliance with relevant guidelines and procedures; able to identify acceptable mitigation actions. - Able to recognize quality risks and develop contingency plans. - Able to assess, establish and implement new quality processes both internally and in partnership with assigned vendors.
Able to author resulting procedures and tools. - Able to recognize patterns in reported data and communicate strategic solutions to stake holders cross-functionally.
- Quality performance / continuous improvement oriented – e.G. - Able to create and maintain meaningful metrics for assigned activities. - Able to recognize trends in product data and results. - Able to assess and recommend improvement measures to processes; able to drive implementation accordingly.
- Skilled in planning and organizing, building relationships, innovation management and resource allocation.
- Ability to negotiate and influence without direct supervising authority in complex, high impact situations.
- Ability to collaborate across a complex and highly dynamic network of BMS internal and external partners and various cultures.
- Ability to be decisive and influence stakeholders internally and externally with demonstrated leadership skills to drive change.
- Demonstrated ability in technical writing, computer knowledge and communication skills.
- Clear presentation and communication skills both, oral and written.
- Experience working with SAP, Deviation Management, Complaint Management, and electronic Document Management Systems.
- Good knowledge of most common office software (Microsoft Office).
- Good verbal and written communication skills in English a must Please note that de to nature of this role it may require your availability to occasional weekend and out of office hours work.
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 excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles.
Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer.
If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com.
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