IT Quality Manager to Södertälje
Technogarden / Chefsjobb / Södertälje
Observera att sista ansökningsdag har passerat.
Visa alla chefsjobb i Södertälje,
Salem,
Ekerö,
Nykvarn,
Botkyrka eller i
hela Sverige Visa alla jobb hos Technogarden i Södertälje,
Botkyrka,
Stockholm,
Solna,
Sollentuna eller i
hela Sverige Company information
Technogarden Engineering Resources has more than 400 active consultants in the Nordic market. Our main fields are Engineering, Supply Chain Management and Production and we are growing constantly. In addition, we are known as one of the most competent partners within recruitment of specialists and managerial positions in the industry. We find the best candidates through search, head hunting and advertisemet. Read more about us at
www.technogarden.se. Our offer
This is a permanent recruitment to our customer who is one of the most respected science-led biopharmaceutical companies with medicines used by millions of patients worldwide. On their behalf we are looking for an "IT Quality Manager" who can take the lead to develop the strategical IT Quality processes and make sure those are followed.
If you are looking for a stimulating and challenging opportunity in a vibrant environment please submit your resume along with a brief introductory letter. In return, we offer a rewarding team environment and a commitment to your ongoing learning and development. Primary project locations will be in Södertälje Sweden, but some travelling will be needed since the function is global in scale with resources in Asia, EU, North America and South America.
Function overview
The IT Strategy and Performance (S&P) organization is responsible for driving the IT Strategic Plan, the IT Operating Model and the overall direction under which IT operates as a business unit.
The Quality Management function is established to cover;
Project Quality Management
Service Quality Management
Regional / Campus Quality Management
This function comprises Quality Management professionals that understand the company 's business processes and are experts at integrating business appropriate risk management techniques.
This function will also consult and educate business and the broader workforce on effectively integrating Compliance Requirements into all IT Lifecycle activities.
Key Accountabilities
The IT Quality Manager will facilitate the realization of the Quality Management strategy for specific areas in Quality Management.
The role will be accountable for the application of Quality Management processes and services to assure that projects, systems, solutions and services delivered by IT and their 3rd party suppliers meet company internal and external regulatory requirements
The role will act upon risks and issues in order to raise compliance and quality levels within IT and the business
Supports the development and roll out of training, education and awareness campaigns for quality and compliance.
Contributes to the continuous improvement of IT Policies, standards and processes
Candidate Focus and challenges
Demonstrated ability to lead the IT Compliance Quality input to System lifecycle activities in support of IT Delivery and maintenance.
Collaborate closely with the project and service teams, ensuring an understanding of the areas of potential Compliance impact that the system may have based on the business process and use.
Demonstrated experience in validation of laboratory and business applications is very important.
Collaborates with system/business process owner to complete or update the Risk Impact Determination (RID) as per the procedure to ensure an understanding of the GxP applicability, business, technical, software category, and regulatory risks.
Review of System lifecycle deliverables including RID, specifications, protocols, reports, and the Test Closure Memo with a focus on cGMP impact, validation lifecycle requirements, and quality, and compliance requirements.
Participate in the review and approval of changes, incidents and problems ensuring completion and update of System Lifecycle deliverables.
Experience in validation of laboratory and business applications.
Collaborates with the IT Project Manager to define the Quality Plan, processes, validation planning, and reporting processes.
Ensure that the project and service teams understand the Quality processes.
Maintains expertise in validation/compliance and develops a greater understanding of quality systems.
Collaborates with project teams on compliance/technical issues related to validation lifecycle efforts to achieve compliance with company policies and government regulations.
Leads / Participates in the Supplier Assessment to ensure that IT Suppliers meet the regulatory requirements.
Ensure that relevant internal business procedures are being adopted and utilized
Authors/reviews/approves departmental Processes
Independently reviews validation documentation for compliance with company policies and government regulations.
Collaborate closely with the Business and IT teams, ensuring an understanding of the areas of GxP, Sox, Data Privacy impact based on the business process and use
Assist with interfaces with the wider Business compliance groups and provide assurance that compliance is maintained during quality management activities.
Provide input to QC dashboard,
Identify and report QC risks and issues to project and service teams
Contribute / lead the development and roll out of training, education and awareness campaigns for quality and compliance
Act as a QC point of contact for any potential internal and/or regulatory inspection
Candidate Knowledge, Skills & Experience
BA, BS in Computer or Life Sciences with 3-5 years of experience in the pharmaceutical industry regulatory requirements
Understanding of global Pharmaceutical Regulations (FDA, Annex 11, Sarbanes Oxley, etc.)
Knowledge of industry best practice and standards such as GxP, CMMI, SPI, GAMP, ITIL, COBIT, Risk Management
A working knowledge of governance of 3rd party relationships.
It is expected that the candidate would come from a good solid IT background, with a specialization in Quality, Compliance including Sarbanes Oxley.
Experience of contributing to implementation of the Quality and/or Compliance strategy with the ability to prioritise and understand the impact of the decisions made
Experience of operating cross business functions and geographies in large, complex and sometimes uncertain IT environments
Strong communication, influencing and relationship building skills
Strong change leadership and team working skills
Personal requirements
We expect you to have excellent communications and interpersonal skills with a strong customer focus. Good problem solving skills coupled with a strong aptitu...
Varaktighet, arbetstid
Heltid Recruitment to customer
Publiceringsdatum2016-11-17Ersättning Lön enligt överenskommelse
Så ansöker duSista dag att ansöka är 2016-12-31
Klicka på denna länk för att göra din ansökanKontaktAli Rezaei
ali.rezaei@technogarden.se +46 739 808391
FöretagTechnogarden
AdressTechnogarden
Hantverkargatan 5K
11221 Stockholm
KontorsadressHantverkargatan 5K , Stockholm
Jobbnummer 3166295
Observera att sista ansökningsdag har passerat.