Lead Operational Quality Assurance (m/w/d) New Assets

TN Germany; Frankfurt; Hybrid; EUR 60.000 - 100.000; Vollzeit

Zusammenfassung

An established industry player is seeking a Lead for Operational Quality Assurance in Frankfurt. This pivotal role involves leading QA processes for New Assets, improving deviation systems, and managing training administration. The ideal candidate will have a strong background in the pharmaceutical industry, with proven leadership skills and a deep understanding of cGMP and regulatory requirements. You will thrive in a hybrid work environment, contributing to a culture that values innovation and collaboration. Join a global family business that prioritizes career development and work-life balance while making a meaningful impact on patients' lives.

Leistungen

Opportunities for career development

Hybrid work model

Modern workplaces

Company restaurant

Employer-subsidized benefits

WellPass

Deutschland-Ticket

Corporate Benefits

JobBike

Qualifikationen

• Minimum 3 years of experience in the pharmaceutical industry.
• Proven leadership experience in Quality Assurance.

Aufgaben

• Lead and develop operational QA processes for New Assets.
• Oversee and enhance the CAPA system, managing CAPA processes in Jira.

Kenntnisse

Leadership

Quality Assurance

Analytical Thinking

Communication Skills

Problem-Solving

Knowledge of cGMP

Team-Oriented

Ausbildung

PhD in Pharmacy or Chemistry

Bachelor's in Pharmacy or Chemistry

Tools

Jira

Smartsolve

Microsoft Office

Jobbeschreibung

The job description is somewhat repetitive and contains some formatting issues. Here's a refined version with improved clarity and structure:

Lead Operational Quality Assurance (m/w/d) New Assets, Frankfurt

Client: [Client Name]

Location: Frankfurt, Germany

Job Category: Other

EU work permit required: Yes

Job Reference: 589921642322

Job Views: 1

Posted: 05.05.2025

Expiry Date: 19.06.2025

Job Description

Join our global quality operations team as a Lead for Operational Quality Assurance of New Assets. In this role, you will:

• Lead and develop operational QA processes for New Assets
• Organize, monitor, and improve the deviation system, process deviations in Jira, and ensure timely resolution
• Oversee and enhance the CAPA system, managing CAPA processes in Jira
• Manage training administration for Therapeutics Operations and handle document management in Smartsolve
• Develop product documentation for process, transport, and method validation and transfers for New Assets
• Create PQRs for New Assets
• Represent the area during inspections by authorities and customers
• Act as Subject Matter Expert for deviations, CAPAs, and training management
• Serve as the contact person for internal and external stakeholders

Your Profile

• Completed scientific studies in Pharmacy, Chemistry, or a related field; PhD is an advantage
• Minimum 3 years of experience in the pharmaceutical industry
• Proven leadership experience, ideally within Quality Assurance
• Good knowledge of cGMP (EU, FDA), GDP, and change control processes
• Proficiency in Microsoft Office, database queries, and electronic QM and SOP systems
• Knowledge of national and international pharmaceutical and medical device requirements
• Analytical thinking and ability to understand complex matters
• Team-oriented, proactive organizational skills
• Strong communication and problem-solving skills with a confident demeanor
• Excellent verbal and written communication skills in German and English

Your Benefits

• Opportunities for individual career development in a meaningful role, improving patients' quality of life
• Hybrid work model supporting work-life balance
• Modern workplaces at an attractive location with good transport links and a company restaurant
• Global family business with flat hierarchies and an open, respectful culture
• Competitive salary with extensive social benefits
• Employer-subsidized benefits such as WellPass, Deutschland-Ticket, Corporate Benefits, and JobBike

Find out more about our benefits here.