Senior Director of Quality – Biotech Manufacturing

Fraser Dove International; Niedersachsen; Vor Ort; EUR 80.000 - 120.000; Vollzeit

Zusammenfassung

Ein führendes Unternehmen im Bereich Life Sciences sucht einen Senior Director of Quality für ihre Biotech-Fertigung in Niedersachsen. Diese Schlüsselposition bietet die Möglichkeit, die Qualitätsstrategie zu leiten und sicherzustellen, dass alle Produkte den höchsten Standards entsprechen. Sie werden für die Entwicklung und Umsetzung eines umfassenden Qualitätsplans verantwortlich sein, der die Einhaltung der EU-GMP-Vorgaben gewährleistet. Mit über 10 Jahren Erfahrung im Qualitätsmanagement und einer Leidenschaft für kontinuierliche Verbesserung sind Sie der ideale Kandidat, um in einem dynamischen und innovativen Umfeld einen bedeutenden Einfluss zu haben.

Leistungen

Relocation

Company Car

Short Term Incentive

Long Term Incentive

Qualifikationen

• 10+ Jahre Erfahrung in pharmazeutischen und Biotech-Qualitätsrollen.
• 5+ Jahre Führungserfahrung mit direkten und indirekten Berichten.

Aufgaben

• Leitung der Qualitätsfunktion an einem Biotech-Standort.
• Entwicklung und Umsetzung eines robusten Qualitätsplans.

Kenntnisse

Qualitätsmanagement

EU-GMP Compliance

Führungskompetenz

Konfliktlösung

Strategisches Denken

Qualitätskontrolle

Jobbeschreibung

Senior Director of Quality – Biotech Manufacturing

Are you an experienced Quality leader ready to shape and steer site strategy?

Do you thrive in regulated biotech environments and have a passion for driving continuous improvement?

Looking to join a purpose-driven organisation focused on global health and innovation?

Fraser Dove International is partnering exclusively with a leading Life Science organisation. Operating from Lower Saxony, Germany, they are committed to advancing the health of people, the planet, and their enterprise.

Our client is seeking a strategic leader to oversee all Quality operations at their Biotech manufacturing site in Lower Saxony, Germany.

Discover more about our Senior Director of Quality – Biotech Manufacturing opportunity, including its objectives, duties/responsibilities, and the skills, experience, and competencies needed to succeed.

Your objectives :

As the Senior Director of Quality – Biotech Manufacturing, you will be measured against the following objectives :

• Provide strategic leadership for the Quality function, including Quality Assurance, Compliance, and Quality Control activities at the site level.
• Ensure successful inspection readiness and ongoing compliance with EU-GMP and regulatory expectations.
• Support product launches, transfers, and technical development activities in collaboration with global R&D and site functions.

What you will do :

As the Senior Director of Quality – Biotech Manufacturing, your duties and responsibilities will include :

• Lead the Quality function for a Biotech manufacturing site, including QA, QC, and Compliance.
• Drive development and execution of a robust Quality Plan as part of the Site Leadership Team.
• Oversee GMP manufacturing, product testing, and the release of raw materials, packaging, and finished goods.
• Ensure readiness for, and leadership during, regulatory inspections.
• Champion robust root cause investigations and effective CAPA implementation.
• Partner with global R&D and other functions to ensure compliant product development and transfer.
• Develop and mentor a team of 45, including 5 direct reports, fostering technical and leadership growth.

What you will bring :

These are the skills and experience you will need to succeed as the Senior Director of Quality – Biotech Manufacturing :

• 10+ years of experience in pharmaceutical and/or Biotech Quality Assurance roles.
• 5+ years of people leadership experience, including direct and indirect reports.
• Demonstrated knowledge of EU-GMP and experience managing inspections.
• Versatility in conflict resolution and problem-solving within cross-functional teams.
• Strong strategic mindset and business acumen.
• 2 years in Quality Control.

What you will get :

These are the perks and benefits that will complement your generous base salary :

• Relocation
• Company Car
• Short Term Incentive
• Long term Incentive

Got what it takes?

To apply for the Senior Director – Biotech Manufacturing, click the ‘Apply’ button below or contact the Executive Search Consultant – [Peter Vedde] – on [phone].

Please Note :

• This job description in no way states or implies that these are the only duties to be performed by the employee(s) in this position. Employee(s) will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorized to give instructions or assignments.
• If you have not heard from an Executive Search Consultant within ten working days from the date of your application, please consider yourself unsuccessful on this occasion.
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Location: Senior Manufacturing, Lower Saxony, Germany