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

Octapharma Sweden; Stockholms län; On-site; SEK 1,962,000 - 2,447,000; Full time

Job summary

Octapharma Sweden is seeking a senior QA leader to advance GMP compliance and harmonise global quality systems across sites. You will drive deviation management, CAPA programs and change control while coordinating cross-site QA initiatives and audits.

Travel within Europe is expected as part of the role. The ideal candidate has 10+ years in pharmaceutical QA, strong stakeholder skills, and a background in GMP operations across Europe and the US.

Qualifications

• 10+ years QA experience in pharmaceutical manufacturing.
• Experience overseeing GMP quality systems and cross-site quality initiatives.
• Strong stakeholder management and collaboration across sites.
• Willingness to travel 5-10 times per year, mainly in Europe.
• Audit experience is desirable but not required.

Responsibilities

• Act as Group Subject Matter Expert for GMP regulations and guidelines.
• Monitor evolving GMP regulations and communicate changes through Quality Bulletins.
• Lead development and harmonisation of the Pharmaceutical Quality System and templates.
• Participate in and support intersite audits of manufacturing and packaging sites.
• Coordinate Group Quality activities including mock recalls and alignment with QA teams.

Skills

GMP compliance

Quality systems

Deviations & CAPA

Change control

Investigations

Cross-site leadership

Stakeholder management

Travel Europe

Education

University degree in Chemistry, Chemical Engineering, Pharmacy, or comparable field

Job description

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.