Group Lead Expert (m/f/d) - Pharmaceutical Quality System

Octapharma-Plasma; Wien; Vor Ort; EUR 80.000 - 120.000; Vollzeit

Benefits dieser Stelle

Salary & benefits

Career development

Zusammenfassung

Octapharma is seeking a Group Lead Expert for Pharmaceutical Quality System to guide GMP compliance across multiple sites in Europe. The role focuses on leading QA initiatives, harmonising quality processes, and driving global procedures in a senior capacity.

The candidate will oversee regulatory changes, coordinate audits, and manage cross-site quality programs while traveling 5–10 times per year within Europe. A deep GMP background and leadership experience are essential.

Qualifikationen

• 10+ years of QA experience in pharmaceutical manufacturing and GMP quality systems across Europe and the US.
• Proven experience leading cross-site quality initiatives and harmonising processes.
• Strong stakeholder management and ability to drive collaboration across sites and teams.

Aufgaben

• Act as Group Subject Matter Expert for GMP regulations and guidelines, advising Octapharma sites on GMP topics.
• Monitor evolving GMP regulations, assess impact and communicate 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 annual mock recalls and alignment with local QA teams.

Kenntnisse

GMP regulations

Quality systems

Cross-site leadership

Stakeholder management

CAPA & deviations

Ausbildung

University degree in Chemistry, Chemical Engineering, Pharmacy

Jobbeschreibung

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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 inVienna (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.