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Director of Qc Biologics
hace 2 semanas
**Director of QC Biologics - Spain**
We are actively seeking a knowledgeable and experienced Director of Quality Control, motivated by collaboration and driven to oversee all responsibilities within their domain with strict adherence to regulatory requirements. This crucial role calls for robust leadership skills to cultivate smooth communication, coordination, and collaboration among diverse cross-functional teams. The position is inherently multidisciplinary, demanding adept interfacing across all organizational levels.
**RESPONSIBILITIES**:
- Supervising the qualification and maintenance of the area, services, and equipment.
- Approving specifications, sampling instructions, and Quality Control procedures.
- Ensuring proper validations are conducted.
- Exercising judgment to approve or reject starting materials, packaging materials, active substances, or finished products.
- Approving and monitoring contract analyses.
- Fostering the proper development of activities within stability programs.
- Overseeing the execution of all required tests and evaluating associated records.
- Ensuring that the initial and ongoing training of personnel is conducted and tailored to organizational needs.
In addition, the Director of Quality Control shares responsibilities for the Quality Area with the Head of Production and the Head of Quality Assurance. These cooperative functions include the design, effective implementation, monitoring, and maintenance of the quality system. Specifically, these functions encompass:
- Authorizing written procedures and other documents, including amendments.
- Conducting environmental monitoring and control of production areas.
- Managing plant hygiene.
- Performing process validations.
- Leading team training initiatives.
- Approving and monitoring material suppliers.
- Approving and overseeing outsourced activities of NCF suppliers and services.
- Establishing and monitoring storage conditions of materials and products.
- Managing record retention.
**REQUIREMENTS**:
- Possessing over 7 years of expertise in a cGMP setting within the biotech/biopharma sector.
- Demonstrating a profound understanding of Quality systems, including NCFs, GLPs, ISO, etc.
- Showcasing insightful comprehension of global quality control systems regulations, facilitating the adoption of advanced-edge systems/processes, and championing continuous improvement initiatives.
- Exhibiting proficiency in establishing robust partnerships and seamlessly integrating with external collaborators to drive projects/programs in a matrixed environment.
- Holding a degree at the Bachelor’s, Master’s, or Ph.D. level in life sciences.
- Demonstrating outstanding teamwork and interpersonal skills, excelling in influencing and nurturing robust working relationships across all organizational levels.
- Possessing detailed knowledge of QC principles, concepts, industry practices, and standards.
- Displaying adeptness in managing evolving priorities to meet critical deadlines within a rapidly changing, knowledgeable, and expanding setting, all while providing clear guidance to team members.
- Boasting over 5 years of leadership experience, with a preference for exposure to CDMO.
- Having a record of leading regulatory inspections and navigating the intricacies of FDA regulations.
- Exhibiting excellent organizational and communication skills.
- Being well-versed in the intricacies of current Good Manufacturing Practices (cGMPs).
**WHAT TO EXPECT**:
- Outstanding salary (average 90.000 - 100.000 EUR) exclusively depending on years of experience, management experience, education, certifications and experience aligning to the role
- Outstanding bonus brackets, ranging from 10 %, 15% or 20% depending on same factors above
- Possible entry as Head of, Director or Executive Director member of the board depending on experience and business acumen (strategic knowledge, management experience, etc)
- Career path setup upon onboarding with a potential 6 month timeline promotion opportunity
- Company shares and stock options depending on seniority offered
- Relocation package
- Fantastic place to live in (city of 210.000+ inhabitants). Production site 3km from the city center, airport 1 km distance, seaside 90 km distance. Great quality of life, excellent for family upbringing
