VP Head of Global Quality

Sobi

Stockholm, Sweden

Job Description

In the role as VP Head of Global Quality you will lead and manage Sobi Global Quality department. Global Quality is responsible for Sobi cGxP Compliance worldwide covering Quality Assurance from development programs to commercial products and activities. Accountable to ensure that Sobi’s Global Quality Management System, GxP strategies and operations is line with all relevant authority regulations worldwide. Lead the global quality team, fostering a culture of continuous improvement and operational excellence. In this role you are reporting into our Head of Technical Operations.

Key Responsibilities

Ensure products, processes, systems and procedures are in compliance with cGxP, relevant authority requirements and global Sobi procedures within Sobi and its affiliates. Establishing and maintaining quality procedures and ensure implementation in accordance with applicable laws, regulations and guidelines in compliance with Sobi global procedures and processes.
Lead the design, implementation and development of a proactive and efficient Quality organisation with competencies to ensure reliable development, manufacturing and delivery of competitive products and processes in regulatory and GxP compliance.
Responsible for the Global Sobi Quality Management System and that all elements are effective and working in compliance with regulatory requirements and applicable law.
Establish and maintain a proactive and efficient Quality oversight of all relevant vendors and suppliers in Sobi Global supplier network. Ensuring that all vendors and suppliers that provides GxP regulated services and products are in compliance with relevant authority regulations and market approvals.
Ensure efficient operations, collaboration and interconnectivity within the quality area for all vendors and suppliers in Sobi Global supplier network. Owner of quality agreements with all relevant vendors and suppliers ensuing that these are outlined and operated with an anticipative mindset and continually monitoring performance.
Accountable for Sobi GxP compliance Audit plan and execution. Accountable for Regulatory inspections, everyday inspection readiness throughout the organization, inspection execution and all relevant follow up.
Responsible for QP release of products within area of responsibility and that delegate QPs are trained within own organization.
Ensure Quality and GxP Compliance representation in due diligence and integration activities with a clear perspective of Quality requirements and Sobi business
Ensure that the Senior Management team (ExCom) in Sobi as well as relevant stakeholders are informed of all aspects of significance within the area of responsibility.
Responsible for attracting and retaining talent and the development of all employees in the Quality team.
Collaborate with cross-functional teams, including R&D, CMC science & technology, manufacturing, supply chain, to drive quality initiatives and resolve quality-related issues.
Responsible for SHE in own area
Ensure budget adherence and maintain resource overview and plans.

Qualifications

Master degree in pharmacy or other relevant degree (Engineering, Chemistry or alike)
Minimum 20 years' experience from pharmaceutical industry within quality, manufacturing, product development and/or regulatory affairs
Minimum 10 years leadership experience with the ability to inspire and motivate a diverse team and with a proven track to attract, retain and develop talent.
Solid experience of leading of a global, multi-cultural organization spread over several continents
In-depth knowledge of global regulatory requirements (e.g., FDA, EMA, ICH) and quality standards (e.g., GMP, GCP, GDP, ISO) for pharmaceuticals and devices.
Extensive experience of working with quality oversight and operations in an outsourced environment and proven track record of successful partnership and efficient collaboration with partners, vendors and suppliers.
Solid and hands on experience of GMP manufacturing, process and analytical development throughout the full supply chain DS/API, DP and Finished Goods and preferably from several different modalities eg Small molecules, biologics etc
Understanding of the pharmaceutical market interrelations and implications
Financial understanding and budget management experience
Experienced in working with high impact stakeholders, e.g. authorities, strategic business partners.