QA Manager - Development

NextPharma Technologies Holding Ltd; Tampere; On-site; EUR 90,000 - 130,000; Full time

Benefits offered by this job

Flexible working hours

Lunch and well-being benefit

Leisure insurance

Company events

Professional development

Job summary

NextPharma Tampere seeks an experienced QA Manager – Development to lead QA oversight for late-stage development activities, process validation, technology transfer, and readiness for commercial manufacturing. You will guide a team of specialists and collaborate with the site Product Development Team and Production to ensure GMP-compliant programs.

This senior, permanent role reports to Head of Quality Tampere and requires strong GMP expertise, people skills, and cross-functional collaboration

Qualifications

• Bachelor's or Master’s degree in a scientific discipline (pharmacy, chemistry, biotech, life sciences, or related).
• Minimum 3 years of experience in pharmaceutical or highly regulated industry.
• Strong GMP knowledge and pharmaceutical quality systems.
• Proven leadership or potential for leading QA teams.
• Hands-on experience with process validation and late-stage development.
• Experience supporting technology transfer and commercialization actions.
• Fluency in Finnish and English.
• Experience with health authorities and regulatory inspections.

Responsibilities

• Coach and develop QA professionals within the Development Quality function.
• Serve as a trusted business partner to cross-functional development teams.
• Influence quality decisions while maintaining independent quality oversight.

Skills

QA leadership

GMP expertise

Regulatory inspections

Process validation

Technology transfer

Stakeholder management

Finnish language

English language

Education

Bachelor's or Master's degree in Pharmacy, Chemistry, Biotechnology, Life Sciences, Engineering

Job description

Select how often (in days) to receive an alert:

We are one of the leading European contract manufacturers in the pharmaceutical, biotech and healthcare sectors, with some 2,300 employees in Germany, France, Finland, UK and Norway. For us, the next step is always the one that matters most. Our fast pace drives us forward, fills our working environment with life and spurs our growth. Our winning formula for shared success: room for passion. Because we know that passion is the best medicine when it comes to excellent service around the world. Welcome to NextPharma.

NextPharma Tampere hasseveral decades of extensive experience in pharmaceutical development, commercial manufacturing and packaging of ophthalmic productsBFS (Blow Fill Seal), MD (Multi dose) and PFMD (preservative free multi dose ophthalmic products). The products we manufacture are globally exported.

Interested in shaping Quality Excellence in Pharmaceutical Development?

We are seeking an experienced and highly motivated QA Manager – Development

In this critical leadership role, you will provide QA oversight for late-stage pharmaceutical development activities, process validation, technology transfer and commercial readiness. You will ensure that development programs progress in compliance with GMP requirements while supporting the successful transition from development to commercial manufacturing. You and your team (3–4 Specialists) work closely together especially with the site Product Development Team and Production.

This is an exciting opportunity for a quality professional who combines People skills, strong GMP expertise, scientific understanding and a collaborative mindset to support innovative pharmaceutical products through pivotal development stages.

Key Responsibilities:

• Coach and develop QA professionals within the Development Quality function.
• Serve as a trusted business partner to cross-functional development teams.
• Influence quality decisions while maintaining independent quality oversight.

Quality Oversight of Development Activities

• Provide QA support for late-stage development programs, including Phase III and registration-enabling activities.
• Ensure compliance with applicable GMP, ICH, FDA, EMA, and other regulatory requirements.
• Review and approve development documentation, protocols, reports, and other quality-related documents.

Process Validation & Commercial Readiness

• Lead QA oversight of process validation activities, including:
  • Process validation
  • Cleaning Validation
  • Hold Time Studies
  • Analytical Method Validation and Transfer
• Review and approve validation master plans, protocols, and final reports.
• Ensure validation strategies are scientifically sound and compliant with regulatory expectations.
• Support process characterization and risk management activities.
• Act as QA representative for technology transfer projects.
• Partner with Manufacturing, Product Development, Engineering, Validation, and Supply Chain teams.
• Ensure readiness for commercial manufacturing and regulatory inspections.

Quality Systems & Compliance

• Manage investigations, deviations, CAPAs, change controls, and risk assessments related to development and validation activities.
• Monitor quality metrics and identify opportunities for continuous improvement.
• Support internal audits, supplier audits, and regulatory inspections.
• Promote a culture of quality excellence and compliance throughout the organization.

What we hope you bring:

• Bachelor's or Master's degree in Pharmacy, Chemistry, Biotechnology, Life Sciences, Engineering or a related scientific discipline.
• Minimum of 3 years of experience in the pharmaceutical or other highly regulated industry.
• Strong expertise in GMP regulations and pharmaceutical quality systems.
• Leadership Experience / Potential, Excellent communication and stakeholder management skills.
• Hands-on experience with process validation and late-stage product development.
• Experience supporting technology transfer and commercialization activities.
• Fluency in Finnish and English.
• Experience interacting with health authorities and supporting regulatory inspections.

What We Offer:

• Opportunity to contribute to innovative therapies that improve patients' lives.
• A pivotal role within a growing and dynamic organization.
• Collaborative international environment with strong cross-functional exposure.
• Competitive compensation and benefits like flexible working hours, lunch and well-being benefit, leisure insurance and company events.
• Professional development and career growth opportunities.

It is a permanent senior white-collar position and you would report to Head of Quality Tampere. We hope you could start working in September–October 2026.