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QA GCP Manager

PharmaRelations are proud to support Swedish Orphan Biovitrum in the recruitment of a QA GCP Manager to their global QA GCP Team.

If you have a sound understanding of GCP guidelines and regulations, along with experience in carrying out and leading audits and clinical trials, this is a unique opportunity for you to join Sobi.

The team currently consists of two people located in Switzerland and the Director Clinical & CMC Compliance in Stockholm. The QA GCP team is part of the Global Quality department of Sobi, with the objective of implementing, developing, and maintaining standards and quality systems to make sure that the company is compliant with Good Clinical Practice (GCP). The team collaborates primarily with R&D/Clinical operations and Medical Affairs departments, and QA Managers within other GxP areas. The position as QA GCP Manager is a global role, focused on quality assurance for Sobi’s worldwide clinical programs. You would be part of a committed and competent team and involved in the expansion of GCP QA within Sobi.

Key responsibilities

– Plan, lead, conduct and report audits in the GCP area, such as e.g. investigator site audit, system or process audits and vendor audits and qualification. Audits are performed both internally as well as externally on an international basis. Travel up to 25% expected.
– Work with contract personnel or consultants to prepare, conduct and report outsourced audits.
– Support the preparation, coordination and management of regulatory GCP inspections as assigned.
– Document audits and inspections in the internal audit management e-system, assess responses, and follow-up and track corrective and preventive actions following audits and inspections.
– Involved in revision of QA processes and procedures including SOPs and risk assessment tools.
– Act as Quality Approver for GCP Non-Conformances and CAPAs in the internal e-system for handling of non-conformances and CAPAs.
– Provide GCP guidance and training to Clinical operations and Medical Affairs departments as needed.

Qualifications

– M.Sc. degree in Pharmacy, Chemistry, Medicine or other relevant degrees.
– Fluent in English verbally and in writing.
– Minimum 5 years of experience from the pharmaceutical industry within GCP/clinical trial responsibilities.
– Minimum 2 years of audit experience within GCP.
– In depth UpToDate knowledge and understanding of relevant regulations and quality standards in the GCP area.
– Extensive experience from working in an international organization and across borders.
– Preferred experience from working within a Quality organization.

Personal attributes

– High ethical standards, trustworthy, operating with integrity
– Strong collaborative, partnering, and interpersonal skills
– Strong communication skills
– Ability to work independently
– Ability to prioritize, take decisions and act upon them

Location

The position will be based at Sobi HQ in Stockholm, Sweden.

Reporting to

Helena Lindberg, Director Clinical & CMC Compliance, Global GxP Compliance and Quality Systems.

Application

We warmly welcome applications from suitably qualified candidates. If you are interested in this position, please apply with an updated CV and Cover letter in English to PharmaRelations. Applications will be assessed ongoing by Kristina Edholm (kristina.edholm@pharmarelations.se).

Read more about QA GCP Manager here!