Senior Manager, QA E-Systems
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Position: Senior Manager, QA E-Systems
Supervisor: Director, QS & Compliance
Prerequisites: BSc or MSc in Sciences, Computer Science or related field.
+ minimum of 10 years Quality Assurance and/or Quality Control IT systems application experience in a GMP pharmaceutical company
The Sr Manager QA E-Systems is responsible for providing quality oversight and helping to ensure the quality, integrity and Compliance of Site Information Technology (IT) /Automation systems supporting the GMP manufacturing, testing and release of product manufactured in Boudry.
The Sr Manager will lead the QA E-Systems team and ensure IT/Automation Systems are designed, setup and function in a GMP compliant manner contributing to products quality and safety.
The Team supports the QA functionality in the Electronic Batch Record system (Oracle), as well as the approval of Master Data and is responsible for maintenance and local administration/superuser.
In addition, the Sr Manager is responsible of the Data Integrity program management and site compliance to associated requirements.
The position will be a key player in major project on site as well at network level.
Capability to drive changes and lead team through changes.
The position is also responsible for reinforcing a continuous improvement mindset within the team.
Act as a delegate of the Director, Quality Systems & Compliance and for peers.
He/she will closely interact with Manufacturing, Technical Services, QC, QA, MDM, MS&T and IT as well as with Global partners.
- BSc or MSc in Sciences, Computer Science or related field, minimum of 10 years of experience in a pharmaceutical company or other related industry.
- Strong understanding of requirements for Computer System Validation.
- Requires ability to communicate appropriately with regulatory agencies
- Demonstrated ability to build relationships and foster team cohesion.
- Excellent management and negotiation skills.
- Ability to motivate and engage teams across functions
- Good problem-solving, critical-reasoning, and decision-making skills.
- Good time-management, organizational, and multi-tasking abilities.
- Ability to solve routine and complex problems.
- Strong knowledge of GMP Regulations required
- Knowledge of CFR 21 Part 11 is a plus.
Duties and Responsibilities
a.Lead the QA eSystems team and be accountable for Quality Oversight of IT/automated Systems under the team’s responsibility with follow up on deviation investigation, Quality Oversight of Oracle MDM and Data Integrity activities.
b.The position holder is responsible for leading, coaching and supervising the assigned personnel in direct line. Provide continuous support and adequate coaching to ensure direct reports fulfil their duties and objectives. Assures continuous professional development and guidance to direct reports. Promote continuous improvement within the team.Work collaboratively on a daily basis with peers in Quality as well as operations to ensure a successful evolution of the site. Drive this culture into his/her team.
c.Ensure that e-System team is appropriately voiced and represented in projects.
d.Coordinates the Data Integrity program on site and ensure data integrity assessment and gap remediation. Provides support and guidance to other departments and functions for Data Integrity topics.
e.Represents the site in Global Forum or Community of Practices.
f.Electronic Batch Management: Provide QA eSystems support for the QA functionality in the Oracle EBS application, support to QA end users, provide a QA review and approval of master data for the PTM elements of the Oracle EBS system for Boudry.
g.Provides input and quality approvals for validation documentation that supports enterprise systems or applicable site and/or globally owned systems.
h.Coordinate with IT and other site departments to maintain and support electronic systems that are compliant, efficient, effective and reliable.
i.Ensures all required system documentation is maintained as changes in the system(s) are made. Documentation includes, but not limited to functional requirements, user requirements, and design specifications.
k.Reviews and approves documents, change controls, and protocols related to IT systems (site and global).
l.Supports the e-Systems related investigations, root cause analyses and CAPA definition as needed
m.Act as QA eSystems Administrator and Superuser functions for key systems.
m.Supports Health Authority Inspections and internal audits if required as SMEs
o.EHS: Line Managers shall provide a safe and healthy work environment for their staff in areas under their control and shall ensure compliance with relevant rules and legislation in those areas.
Deputy Role for and deputy activities
Director, QS & Compliance and peers
Definitions and Abbreviations
CAPA: Corrective and Preventive Actions
GMP: Good Manufacturing Practices
IT: Information Technology
QA: Quality Assurance
ERP: Enterprise Resource Planning
GIM: Global Internal Manufacturing
GMP: Good Manufacturing Practice
GQS: Global Quality Systems
MES: Manufacturing Execution System
MDM: Master Data Management
MS&T: Manufacturing Systems & technology
QC: Quality Control
SME: Subject Matter Expert
Wir setzen uns auf der ganzen Welt leidenschaftlich dafür ein, das Leben von Patienten mit schweren Krankheiten zu beeinflussen. Unsere gemeinsamen Werte Leidenschaft, Innovation, Dringlichkeit, Verantwortlichkeit, Inklusion und Integrität befähigen uns, unsere individuellen Talente und unterschiedlichen Perspektiven in einer integrativen Kultur einzusetzen und bringen das höchste Potenzial jedes unserer Kollegen hervor.
Bristol Myers Squibb weiß um die Bedeutung von Balance und Flexibilität im Arbeitsumfeld. Wir bieten daher eine Vielzahl von attraktiven Benefits, Dienstleistungen und Programmen an, die unseren Mitarbeitern die Ressourcen bieten, ihre Ziele sowohl bei der Arbeit als auch in ihrem Privatleben zu verfolgen.