Operational IS/IT Quality Manager
New role within IS/IT at Sobi where you will lead and improve the development of internal quality systems!
Your new role
Sobi is a dynamic and growing company with a high pace of change. We are now looking for an Operational IS/IT Quality Manager to join our IS/IT team to manage and support all IS/IT related quality activities, e.g., deviations, CAPAs, changes, periodic reviews, qualifications, validations, SOPs, quality related training and audits. The position is within the Information and ERP Systems department, with a dotted line to IT Operations at HQ level, and will report to the head of Information and ERP Systems.
Main areas of responsibility
Operationally manage and support all IS/IT related quality activities, e.g., deviations, CAPAs, changes, periodic reviews, validations, quality related trainings and internal and external audits
Initiate and suggest improvements to the current quality system and processes
Lead and support initiatives to implement improvements to the current quality system and processes
Support and coordinate external quality related resources, e.g., validation leaders in system implementations and upgrades
Participate and actively support projects as quality specialist
Be up to date with regulatory requirements within the area of computer compliance
Own and manage the IS/IT Quality Activity Plan, which covers all planned quality activities each year
You will also be Super user / System Analyst for our Quality system (SmartSolve)
What you'll need to succeed
At least 5-10 years of operational hands-on experience working with computer compliance within pharma industry, including experience from roles such as Deviation Investigator, CAPA Coordinator, validation documentation and writing SOPs
Strong knowledge of GxP, FDA and EMEA regulations and experience in implementing 21 CFR Part 11 following GAMP concepts. Specific knowledge of computer validation methodologies and principles
Pragmatic view to quality & compliance to ensure focus are on improving top priorities with focus on quality
Bachelor’s/Master’s degree (or equivalent) in relevant area
Strong personal leadership skills, being able to lead without a title in a matrix organization and move activities forward with limited directions
Outstanding communication skills, written and oral both in English and Swedish
Strong analytical skills, able to understand complex processes
A problem solver with strong operational skills and a hands-on, “get things done” attitude
Our values (Care, Partnership, Ownership, Ambition and Urgency) is the base for our daily work and your professional style should be:
Well-organized, efficient and self-motivated
Demonstrate good interpersonal skills including the ability to interact well with a variety of personalities, organizational and educational levels.
Ability to work independently, attention to detail, maintain accurate records, follow instructions, and comply with company policies.
Proven written and verbal communication skills, both Swedish and English
What you need to do now
For more information about the role, please contact hiring manager Henk Schaake at 08-697 2276. To apply, please submit your application through the Apply button on the left hand side.
Sobi™ is an international specialty healthcare company dedicated to rare diseases. Our mission is to develop and deliver innovative therapies and services to improve the lives of patients. The product portfolio is primary focused on Haemophilia, Inflammation and Genetic diseases. We also market a portfolio of specialty and rare disease products across Europe, the Middle East, North Africa and Russia for partner companies. Sobi is a pioneer in biotechnology with world-class capabilities in protein biochemistry and biologics manufacturing. In 2016, Sobi had total revenues of SEK 5.2 billion (USD 608 M) and approximately 760 employees. The share (STO:SOBI) is listed on NASDAQ OMX Stockholm. More information is available at www.sobi.com.
Swedish Orphan Biovitrum AB