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Employer:  Biogen Idec
Industry:  Biotechnology / Pharma
Country:  Switzerland
State/Province:  Any
City:  Solothurn
09/14/2018 09:03 AM
The Senior Manager, IT Quality is expected to have working-level knowledge of CS and supporting infrastructure at the enterprise and local levels, including the quality systems supporting it (i.e., change management, exceptions management, risk management).
Foundational and executable regulatory expectations for CS. Works with peers locally and globally, when necessary to ensure practices are consistent with requirements and expectations set forth within the governing QMS.
Support health authority inspections as a Quality SME within the space.
The Senior Manager of IT Quality will also be responsible for supporting Corporate Quality initiatives across all sites.

The incumbent is expected to have expert level knowledge of computerized systems (CS) at the enterprise and local level (manufacturing and laboratory execution systems) and the quality management systems (QMS) supporting it.
The incumbent understands industry-wide and regulatory expectations for computerized systems and works with other members of global and site management to ensure practices are consistent with requirements and expectations set forth within the governing QMS; utilizes industry experience to partner and drive the assessment and improvement of global CS practices; functions as the IT Quality representative on global CS initiatives; collaborates and partners with site Quality Assurance to determine an agreed-upon path forward on matters of CS philosophy, implementing those philosophies agreed-upon into executable procedures.

Responsibilities include:
• Support the compliant implementation of GxP computerized systems (i.e., new, upgrades, changes, etc.) to ensure the approach and execution aligns to industry as well as Biogen expectations through the review and approval of life cycle deliverables. Scope includes IT enterprise systems supporting PO&T operations as well as underlying infrastructure. May also include support of R&D Systems.
• Perform and manage all supporting quality related activities associated with computerized systems including periodic reviews, exception management (deviation / CAPA), change management, risk management, etc. in alignment with noted KPIs.
• Support all Global Quality initiatives, including Data Integrity, Computerized Systems and IT QMS implementation / remediation.
• Act as a high-level technical resource for interpretation of policy to ensure alignment in approach and desired acceptance criteria.
• Development, review and approval of technical and strategy documents, including the maintenance of the Validation Master Plan.
• Drive data integrity implementation and remediation for GxP systems. Drive and participate in continuous compliance and improvement efforts.
• Support internal and external audits as the IT Quality point of contact. Lead aspects of inspection preparation and act as a SME, where appropriate. Lead GxP audit readiness activities.
• In partnership with area management, drive improvements to Computerized Systems and IT controls framework.
• Develop training for IT Quality team to keep up-to-date with industry best practices.
• Develop and deliver presentations (i.e., Lunch and Learns) for IT organization on various compliance related topics (i.e., data integrity, warning letters, etc.).

*LI-POT6
Requisition Number
35515BR

Employment Category
Full-Time Regular

External Posting Title
Senior Manager, IT Quality

Job Category
Information Technology, Quality

Qualifications
A minimum of fifteen (15) years related experience and/or training with 2-3 years in a Quality management role. Background in Lifesciences and/or Pharma/Biotech industries (or solid understanding of bioprocessing and support processes). Additionally:

• Must have hands-on experience supporting implementation of computerized systems (i.e., IT, Manufacturing and QC) within a GxP environment either as a CSV and/or Quality lead.
• Ability to complete tasks independently and with limited oversight.
• Ability to interpret regulatory guidance (GxP) and Biogen policies and procedures into executable and defendable lifecycle documentation.
• Depth of understanding of respective regulations governing computer systems and controls such as FDA's 21 CFR Part 11, EMA's Annex 11, and MHRA's data integrity guidance.
• Understanding of risk-based methodologies as it relates to qualification and validation
• Knowledge of underlying infrastructure requirements supporting GxP systems
• Knowledge of SaaS, AWS, etc. and the key compliance components.
• Experience supporting health authority inspections

Education
Bachelor's Degree (BS) from a four (4) year college or university with as emphasis in Engineering, Life Sciences or IT related discipline with relevant experience. Advanced degree preferred.

Experience Level
Mid-Senior Level

Summary
As part of the IT Quality team, deliver technically robust and compliant GxP computerized systems (CS) that withstand audits, both internal and external.


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