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| Advertiser Name | Sanofi EU | | Advertiser Type: | Company |
| Classification: | 6227 | | Subclassification: | |
| Country: | Germany | | Location: | Germany |
| Language: | English - United Kingdom (en-GB) | | Contact Name: | |
| Employment Type: | Permanent | | Workhours: | Not Specified |
Position: Global Quality D&Q Lead InsuLINK (all genders) |
Description:
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About the job We are seeking a highly skilled and experienced Global Quality Design & Qualification Lead for our newest program. This senior leadership position is vital in ensuring the highest standards of quality assurance and compliance throughout our state-of-the-art insulin manufacturing facilities in Europe and China. The role involves overseeing all aspects of Design & Qualification (D&Q) activities, with a focus on qualification, validation, and GMP compliance across the entire TIER 1 program lifecycle from feasibility to Process Performance Qualification (PPQ).
If you are passionate about leading quality assurance, commissioning, and qualification efforts in the pharmaceutical industry, have a strong background in biologic manufacturing, and possess the leadership skills to drive excellence in a complex, cutting-edge environment, we encourage you to apply for this exciting opportunity.
Key Responsibilities:
Ensure proper execution of all aspects of Commissioning and Qualification (C&Q) activities, including qualification of facilities, critical utilities, equipment, and computerized systems.
Define and oversee the program C&Q&V strategy, plans, and system impact assessments.
Develop and implement comprehensive qualification/validation strategies and plans in line with regulatory requirements and industry best practices.
Lead and actively participate in project workstreams related to qualification/validation strategies and quality processes for the InsuLINK program.
Provide regular reporting to the Global Quality Program Lead and ensure project compliance with Sanofi standards and policies.
Manage and mentor the quality assurance and D&Q project team, fostering a culture of excellence and continuous improvement.
Collaborate with cross-functional teams to integrate quality considerations throughout the project lifecycle.
Support regulatory inspections and audits, ensuring the project meets all applicable quality and compliance standards.
Ensure strategic workforce planning of the D&Q organization during both project and routine manufacturing modes.
Responsible for the InsuLINK D&Q budget and schedule, including regular collection of actual quality D&Q program cost and progress.
About you
Qualifications and Requirements:
Advanced degree in Science/Engineering/Pharmacy or Equivalent (MSc or PhD preferred).
Minimum of 8 years of industry experience, preferably in the biopharmaceutical sector for Commissioning, Qualification/Validation, with at least 5 years in a leadership position.
In-depth knowledge of the biologic product license application process, and the associated regulatory requirements.
Strong understanding of GMP compliance, quality systems, and risk management in pharmaceutical manufacturing.
Proven experience in Quality System Management, Commissioning & Qualification, Process Validation Lifecycle, Quality by Design principles.
Effective coaching and mentoring skills, with the ability to develop and lead high-performing teams.
Proficiency in English is required; knowledge of German and French is highly desirable.
Key Competencies:
Strong analytical and problem-solving skills
Excellent project management and organizational abilities
Outstanding communication and interpersonal skills
Ability to work effectively in a fast-paced, dynamic environment
Adaptability and willingness to embrace new technologies and methodologies
Strategic thinking and decision-making capabilities
Strong negotiation and business partnering skills
Attention to detail and commitment to maintaining high-quality standards
What We Offer:
Opportunity to lead quality assurance and D&Q efforts in a major investment program for new large-scale insulin facilities
Chance to contribute to state-of-the-art, fully GMP compliant biologics manufacturing
Collaborative and innovative work environment
Competitive salary and benefits package
Professional development and growth opportunities
Ability to make a significant impact on global health through quality management in insulin production
Key Challenges:
Managing the complexity of establishing quality systems and D&Q processes for large-scale insulin manufacturing facilities in Germany and China
Implementing and overseeing validation strategies for cutting-edge pharmaceutical technologies
Ensuring compliance with evolving regulatory requirements in multiple jurisdictions
Balancing quality assurance needs with project timelines and budgetary constraints
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