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Pharmaceutical Affairs Manager(m/w/x)
Managing change control and SOP harmonization for a global biopharmaceutical group. Several years of GxP experience with change control and TQAs required. Flexible working arrangements, work-life balance initiatives.
Requirements
- University degree in pharmacy, chemistry, life sciences, pharmaceutical sciences, or comparable scientific discipline
- Several years of hands-on experience in Pharmaceutical Affairs, Quality Assurance, or comparable regulated environment
- Proven practical experience with change control, SOP management, deviations, complaints, audits, and TQAs
- Solid understanding of GxP requirements and quality systems
- Experience with local and global quality processes and integrating global standards
- Qualification as a Qualified Person (QP) is advantageous
- Collaborative, team-oriented mindset and effective cross-functional work
- Strong communication and interpersonal skills, confident stakeholder interaction
- Structured, reliable, solution-oriented working style with high ownership
- Fluent English, written and spoken
Tasks
- Manage Change Control process
- Evaluate, coordinate, and document changes
- Update and maintain SOPs
- Harmonise SOPs with global procedures
- Manage Technical Quality Agreements
- Review and revise TQAs regularly
- Handle deviations and complaints
- Support audit planning, execution, and reporting
- Follow up on corrective and preventive actions
- Support supplier qualification
- Review supplier documentation
- Coordinate with internal and external stakeholders
- Organise cross-functional meetings
- Participate in cross-functional meetings
Work Experience
- approx. 1 - 4 years
Education
- Bachelor's degree
Languages
- English – Fluent
Benefits
Competitive Pay
- Competitive salary package
Corporate Discounts
- Top-class benefits
Family Support
- Work-life balance initiatives
Learning & Development
- Development opportunities
Flexible Working
- Flexible working arrangements
- Remote work options
Other Benefits
- Tax assistance services for foreign colleagues
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Pharmaceutical Affairs Manager(m/w/x)
Managing change control and SOP harmonization for a global biopharmaceutical group. Several years of GxP experience with change control and TQAs required. Flexible working arrangements, work-life balance initiatives.
Requirements
- University degree in pharmacy, chemistry, life sciences, pharmaceutical sciences, or comparable scientific discipline
- Several years of hands-on experience in Pharmaceutical Affairs, Quality Assurance, or comparable regulated environment
- Proven practical experience with change control, SOP management, deviations, complaints, audits, and TQAs
- Solid understanding of GxP requirements and quality systems
- Experience with local and global quality processes and integrating global standards
- Qualification as a Qualified Person (QP) is advantageous
- Collaborative, team-oriented mindset and effective cross-functional work
- Strong communication and interpersonal skills, confident stakeholder interaction
- Structured, reliable, solution-oriented working style with high ownership
- Fluent English, written and spoken
Tasks
- Manage Change Control process
- Evaluate, coordinate, and document changes
- Update and maintain SOPs
- Harmonise SOPs with global procedures
- Manage Technical Quality Agreements
- Review and revise TQAs regularly
- Handle deviations and complaints
- Support audit planning, execution, and reporting
- Follow up on corrective and preventive actions
- Support supplier qualification
- Review supplier documentation
- Coordinate with internal and external stakeholders
- Organise cross-functional meetings
- Participate in cross-functional meetings
Work Experience
- approx. 1 - 4 years
Education
- Bachelor's degree
Languages
- English – Fluent
Benefits
Competitive Pay
- Competitive salary package
Corporate Discounts
- Top-class benefits
Family Support
- Work-life balance initiatives
Learning & Development
- Development opportunities
Flexible Working
- Flexible working arrangements
- Remote work options
Other Benefits
- Tax assistance services for foreign colleagues
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
Chiesi Farmaceutici S.p.A.
Industry
Pharmaceuticals
Description
Das Unternehmen ist ein forschungsorientiertes, biopharmazeutisches Unternehmen, das innovative medikamentöse sowie nicht-medikamentöse Lösungen entwickelt und vermarktet.
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