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

Octapharma France; Stockholms län; Presencial; SEK 1 335 000 - 2 002 000; Tempo integral

Resumo da oferta

Octapharma Pharmazeutika Produktionsges.m.b.H. seeks a senior QA expert to drive GMP compliance across Europe and the US, supporting global quality systems and leading harmonisation efforts.

You will oversee deviations, CAPA, Change Control, investigations and SOPs, with travel 5–10 times per year within Europe, collaborating with Quality teams across sites.

Qualificações

• 10+ years QA experience in pharmaceutical manufacturing with GMP focus.
• Extensive experience overseeing GMP quality systems across Europe and the US.
• Proven experience leading cross-site quality initiatives and harmonising processes.
• Experience with deviations, CAPA, Change Control, investigations, validation and SOPs.

Responsabilidades

• 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 development and harmonisation of the Pharmaceutical Quality System (PQS) and global procedures/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.

Conhecimentos

GMP regulations

Quality Assurance

Cross-site leadership

CAPA & deviations

Change control

Investigations

SOP development

Stakeholder management

Audits

Formação académica

Chemistry/Chemical Eng/Pharmacy

Descrição da oferta de emprego

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.

Larissa Amling

Octapharma Pharmazeutika Produktionsges.m.b.H.

Oberlaaer Straße 235, 1100 Wien

T: [phone]

Want to find out more about us?

Visit our website Octapharma Career and follow us daily on LinkedIn.