Lead CSV Compliance Specialist

Placed: 06/12/17
Region: Cambridgeshire
Category: Jobs


Content of the advertisement:

Lead CSV Compliance Specialist - Pharma/Life Science - Permanent - Cambridgeshire

Our client is a leading global pharmaceutical company. At present they are seeking a Lead CSV Compliance Specialist on a permanent basis at their site based in Cambridgeshire. Applicants will be educated to degree level in a related Life Science of IT discipline and will have an operational background in CSV, IT compliance and infrastructure qualification.

Responsibilities:
Implements the Global Quality Management System (QMS) for computerised and IT infrastructure systems in compliance with applicable regulations across a wide portfolio of IT Infrastructure, GLP, GMP, GPvP and GCP business areas.
Embeds processes, procedures and a culture that balances the need for demonstrable compliance while maximising flexibility and agility.
Assists with maintenance of SOX compliance within IS processes.
Provides leadership and representation of the IS Team during Regulatory Inspections (e.g. SOX, MHRA, FDA), ensuring preparedness and overseeing any remediation.
Establishes and conducts an IS quality and compliance training program for internal team members and appropriate stakeholders across the business.
Oversight of Computer System Validation (CSV) and qualification deliverables for computerised and IT infrastructure systems.
Oversight of vendor audits where impact on IT infrastructure and computerised systems.
Provides a clear focus on the development of lean policies and procedures for a risk based approach to infrastructure compliance and CSV.
Supports the authoring and review of project related deliverables (Compliance Assessments/Plans, User/Functional/Technical Requirements, Functional Risks Assessments, IQ/OQ/PQ/UAT Protocols and Test Scripts, Compliance Summary Reports and SOPs).
Provides leadership and guidance to help align IS compliance activities with QA procedures.

Experience:
Extensive knowledge and understanding of cGxPs, management of critical data and the importance of quality (including but not limited to 21 CFR 58, 210, 211, 820, Part 11, Annex 11, and ICH GCP).
Knowledge of information security management standards and IT service management standards.
Experience of the system design lifecycle, project management and development of qualification documentation in a regulated environment.
Interfacing and collaborating with both technical and non-technical colleagues including IT contractors/developers, business stakeholders and customers, vendors/suppliers, at all levels including senior management and board level.
Strong leadership and decision-making skills, able to develop positive coaching/mentoring relationships with direct reports and matrixed team members.
Excellent analytical and problem solving skills. Able to understand and absorb complex information and requirements.
Ability to facilitate effective meetings (e.g. status meetings, functional requirements gathering, process flow development workshops, end user training, etc.).
Excellent organisational skills, meticulous and methodical. Good at prioritising and flexible enough to adapt plans. Comfortable working to tight deadlines and within constraints.
Excellent written and verbal communication skills, strong presentation skills, and able to communicate complex information in simple terms
Understanding of IT concepts and terminology.
Ability to develop pragmatic, innovative approaches to infrastructure qualification and validation within regulatory constraints.
Forms trusting, collaborative and strategic relationships with internal stakeholders and external partners with skills in assertion, negotiation, influencing, tact and diplomacy.
Can instil a culture of considered change management for deliverables in order to drive effective adoption and maximise the focus on a positive customer experience.
Exhibits a Service mentality, recognising and promoting the enabling value that technology can provide to customers