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Head of Quality Control (m/w/d) (EN)

[14112]
Leitung Quality Control, Führungserfahrung

Job title: Site Head of Quality Control (m/w/d) Duration of employment: Unlimited Industry: Pharmaceutical Skills:People management, Quality Control,Leading Skills Ideal starting date: As soon as possible Location: Basel area, Schweiz Leadership:  ·- Foster a collaborative team environment characterized by strong team spirit, timely and effective communication, a sense of urgency, and high motivation. Inspire teams to achieve both immediate and long-term goals. Actively drive and support a mindset of flexibility and openness to new opportunities as a visible change agent. · ·- Assume a leadership role within the Quality Leadership Team (SQ-LT), steering department/site activities, facilitating cross-functional planning, and contributing to decision-making processes. · ·- Lead and coach direct reports, employing inspirational leadership techniques to motivate them towards optimal efficiency. ·- Take accountability for the budget and financial performance of the Quality Control function, including contractor management responsibilities. · ·- Proactively engage in measures to cultivate a positive safety/ SHE culture, ensuring compliance with all Safety, Health, and Environment requirements in alignment with DSM policy and local legal standards. · ·- Exemplify DICI principles and methodologies, instilling a continuous improvement mindset throughout the organization. Encourage experimentation and learning to drive ongoing enhancements. Tasks: ·- Develop, amend, implement, and enforce Quality Control procedures, specifications, and testing methods in accordance with cGMP, Feed/Feed regulations, DSM standards, objectives, and procedures. · ·- Lead the QC team in the prompt completion of various testing activities, including release and stability testing, raw materials assessment, Microbiology (MiBi), in-process samples, direct materials evaluation, and environmental monitoring. · ·- Provide technical guidance to QC staff, ensuring they have the necessary support and knowledge of test methods and relevant procedures. · ·- Ensure the timely generation and reporting of test results to support manufacturing operations, such as In-Process Control (IPC) and hold testing. · ·- Oversee the calibration and maintenance of laboratory equipment and systems. · ·- Facilitate troubleshooting and other product lifecycle testing to support manufacturing operations. · ·- Maintain constant regulatory compliance and inspection readiness for data, documentation, and laboratory processes. · ·- Review, evaluate, and approve system, computer, change control, and analytical data against established criteria. · ·- Generate, document, and report data in adherence to cGMP and other procedures. · ·- Direct the review and approval of all relevant QC documents, ensuring regular updates. · ·- Guide QC staff in the prompt resolution of issues, including discrepancies, investigations, and the implementation of Corrective and Preventive Actions (CAPA). · ·- Escalate potential quality issues arising during QC testing or product processing, especially those with the potential to impact product quality or regulatory compliance. · ·- Support regulatory inspections, customer/certification audits, and the approval of protocols and reports from third-party QC laboratories. · ·- Ensure effective project management, delivering key deliverables On Time and In Full (OTIF). Qualifications: - Over 10 years of professional experience in the pharmaceutical or a related industry.- 7 years or more of leadership experience in managing teams.- 4 or more years experience of quality expertise within the pharmaceutical sector, covering areas such as quality control, analytical sciences, pharmaceutical development, manufacturing, or process development.

Job title: Site Head of Quality Control (m/w/d)
Duration of employment: Unlimited
Industry: Pharmaceutical
Skills:People management, Quality Control,Leading Skills
Ideal starting date: As soon as possible
Location: Basel area, Schweiz



Leadership: 

  • - Foster a collaborative team environment characterized by strong team spirit, timely and effective communication, a sense of urgency, and high motivation. Inspire teams to achieve both immediate and long-term goals. Actively drive and support a mindset of flexibility and openness to new opportunities as a visible change agent.


  • - Assume a leadership role within the Quality Leadership Team (SQ-LT), steering department/site activities, facilitating cross-functional planning, and contributing to decision-making processes.


  • - Lead and coach direct reports, employing inspirational leadership techniques to motivate them towards optimal efficiency.

  • - Take accountability for the budget and financial performance of the Quality Control function, including contractor management responsibilities.


  • - Proactively engage in measures to cultivate a positive safety/ SHE culture, ensuring compliance with all Safety, Health, and Environment requirements in alignment with DSM policy and local legal standards.


  • - Exemplify DICI principles and methodologies, instilling a continuous improvement mindset throughout the organization. Encourage experimentation and learning to drive ongoing enhancements.



Tasks:

  • - Develop, amend, implement, and enforce Quality Control procedures, specifications, and testing methods in accordance with cGMP, Feed/Feed regulations, DSM standards, objectives, and procedures.


  • - Lead the QC team in the prompt completion of various testing activities, including release and stability testing, raw materials assessment, Microbiology (MiBi), in-process samples, direct materials evaluation, and environmental monitoring.


  • - Provide technical guidance to QC staff, ensuring they have the necessary support and knowledge of test methods and relevant procedures.


  • - Ensure the timely generation and reporting of test results to support manufacturing operations, such as In-Process Control (IPC) and hold testing.


  • - Oversee the calibration and maintenance of laboratory equipment and systems.


  • - Facilitate troubleshooting and other product lifecycle testing to support manufacturing operations.


  • - Maintain constant regulatory compliance and inspection readiness for data, documentation, and laboratory processes.


  • - Review, evaluate, and approve system, computer, change control, and analytical data against established criteria.


  • - Generate, document, and report data in adherence to cGMP and other procedures.


  • - Direct the review and approval of all relevant QC documents, ensuring regular updates.


  • - Guide QC staff in the prompt resolution of issues, including discrepancies, investigations, and the implementation of Corrective and Preventive Actions (CAPA).


  • - Escalate potential quality issues arising during QC testing or product processing, especially those with the potential to impact product quality or regulatory compliance.


  • - Support regulatory inspections, customer/certification audits, and the approval of protocols and reports from third-party QC laboratories.


  • - Ensure effective project management, delivering key deliverables On Time and In Full (OTIF).



Qualifications:

- Over 10 years of professional experience in the pharmaceutical or a related industry.- 7 years or more of leadership experience in managing teams.- 4 or more years experience of quality expertise within the pharmaceutical sector, covering areas such as quality control, analytical sciences, pharmaceutical development, manufacturing, or process development.

map Basel, Schweiz date_range 06.02.2024 update Permanent
Direct contact

Antony Polito

Senior Recruitment Consultant
mail a.polito@aristo-group.ch
phone +41 44 27439 00


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