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Group Lead Expert (m/f/d) - Pharmaceutical Quality System Job ID: 63605
Location: Wien, AT Springe, DE Lingolsheim, FR Stockholm, SE
Job Level: Professionals
Job Category: Quality
Become part of a vital chain and contribute to our common goal of making people’s lives better. Octapharma is one of the largest human protein manufacturers in the world, developing and producing medicines sourced from human plasma and human cell lines. We are a privately-owned company, where the warmth of family meets the scale of a global organisation.
The position will be filled in Vienna
(Austria),
Springe
(Germany),
Stockholm
(Sweden) or
Lingolsheim
(France).
Join us in shaping our vision of providing new health solutions advancing human life.
Your main tasks and responsibilities Act as Group Subject Matter Expert for GMP regulations and guidelines, advising Octapharma sites on GMP-related topics
Monitor evolving GMP regulations, assess their impact and communicate relevant changes through Quality Bulletins
Lead the development and harmonisation of the Pharmaceutical Quality System, including global procedures and templates
Participate in and support intersite audits of manufacturing and packaging sites
Coordinate Group Quality activities, including the annual mock recall and regular alignment with local Quality Assurance teams
Your expertise and ideal skill set
University degree in Chemistry, Chemical Engineering, Pharmacy, or a comparable scientific field
10+ years of QA experience in pharmaceutical manufacturing, with extensive experience overseeing GMP quality systems, manufacturing operations, and quality organizations across Europe and the US
Proven experience leading cross-site quality initiatives and harmonising pharmaceutical quality processes
Strong expertise across deviations, CAPA, Change Control, investigations, validation, SOPs and continuous improvement processes, with experience across biologics, sterlie products
Strong stakeholder management skills, with the ability to build trust and drive collaboration across sites, cultures and Quality teams
Audit experience is desirable but not required; however, an interest in developing further in this area is important
Willingness to travel 5–10 times per year, mainly within Europe
You will thrive in this role if you enjoy staying close to evolving GMP requirements, turning them into practical actions and working with Quality teams across different sites to maintain a strong and consistent Pharmaceutical Quality System.
Your department - where you make an impact
We, the Group Quality department, are responsible for the development of policies and procedures for all GQ Plasma activities based on current applicable regulations to ensure a standardized approach throughout the organization.
We are divided into GQ Plasma, GQ Control, Group Quality Assurance, Group Stability Studies, Group QC Method Validation, Group QC Incoming Goods and Group Quality & Compliance Projects.
Thrive with us
You help save lives - Every day is meaningful as we produce life-saving medicines
Family values - Long-term perspective for employees and relationships
Be rewarded with an attractive salary and benefits package
You will have a high level of influence where you can make a difference and leave your footprint
Work with skilled and fun colleagues in a relatively informal organization
Skills development - We offer various internal and external employee and leadership trainings, trainee programs and digital solutions
Additional information (Austria only): The minimum gross salary according to the collective agreement (chemical industry) is EUR 4,355.55 based on 38 hours per week (full-time). As we strive to offer a salary that reflects your individual profile and qualifications, there is a willingness to pay above the minimum salary.
It´s in our blood We live diversity and stand for equal opportunities as an employer! We therefore look forward to receiving your application - regardless of age, gender, origin, sexual orientation, and religion.
Do you have any questions? Then get in touch with your contact person.
Octapharma is one of the largest human protein manufacturers in the world, developing and producing human proteins from human plasma and human cell lines. We employ more than 11,000 people worldwide to support the treatment of patients in 120 countries with products across three therapeutic areas: Immunotherapy, Haematology and Critical Care. With seven R&D sites and five state-of-the-art manufacturing facilities in Austria, France, Germany, and Sweden, Octapharma also operates over 200 plasma donation centres across Europe and the US. With four decades of experience, we are committed to advancing patient care worldwide.
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Group Lead Expert (m/f/d) - Pharmaceutical Quality System in Wien Arbeitgeber: Octapharma Plasma
Als Arbeitgeber im Bereich Blut- und Plasmaspende bieten wir eine sinnstiftende Tätigkeit, die direkt zur Rettung von Leben beiträgt. Unser Spendezentrum in Cottbus zeichnet sich durch ein engagiertes Team, geregelte Arbeitszeiten ohne Nacht- und Wochenenddienste sowie zahlreiche Benefits wie kostenlose Gesundheitsangebote und ein offenes Betriebsklima aus. Wir fördern die persönliche und berufliche Entwicklung unserer Mitarbeitenden und bieten eine strukturierte Einarbeitung in einem zukunftsorientierten Unternehmen.
