The role
For our Prague location, we are currently looking for a skilled and enthusiastic Head of QA & QC Fulltime, Běchovice, Czech Republic
We are seeking an inspiring leader to drive our Quality Assurance and Quality Control strategy across the entire site. In this pivotal role, you will lead the Quality Management System, oversee QC operations, secure GMP compliance, and ensure the delivery of safe, reliable, and high–quality API. Your decisions will truly make a difference—shaping standards, elevating performance, and strengthening the quality culture within the organization. You will report directly to the Site Director Symeres CZ. In this role, you will be responsible for:
QA – Quality Assurance
- Maintain and develop the GMP system in accordance with legislation (Act on Pharmaceuticals, VYR 26, ICH, EU guidelines).
- Create, review, manage and approve GMP documentation (SOPs, POLs, specifications, methods, validation documentation).
- Manage, investigate and close deviations, OOS, change controls and CAPA.
- Plan, conduct and evaluate internal and external audits.
- Ensure authority inspections and customer audits, including remediation of identified findings.
- Investigate and resolve complaints and prepare corrective actions.
- Set up concepts and oversight for qualifications, validations and metrology.
- Train and monitor the education system of employees in the area of GMP.
QC – Quality Control
- Responsible for quality control of raw materials, intermediates and APIs.
- Approve and update analytical methods, specifications and validation documentation.
- Approve and review raw data and final analytical outputs including Certificates of Analysis.
- Oversee maintenance and calibration of analytical instruments.
- Manage and evaluate stability studies and establish retest/shelf-life dates.
- Select, approve and audit external laboratories.
- Prepare and approve the QC department work plan.
- Ensure safety, fire protection and environmental compliance in laboratory operations.
Leadership & collaboration
- Lead and develop the QA/QC team of 9 Fte (4 directly)
- Coordinate and support collaboration with Manufacturing, R&D, Logistics, PM and other departments.
- Communicate with clients and international Symeres colleagues on quality topics.
- Ensure economical operation of the department and effective use of resources.
Qualifications
- The Ideal Candidate Has Experience in Pharmaceutical Manufacturing or Development and Meets Most of the Following:
- Senior experience in QA/QC and people management.
- Excellent knowledge of GMP (Act on Pharmaceuticals, VYR 26, ICH Q7 / ICH Q1 / ICH Q2).
- Experience with API quality, audits, inspections, OOS/deviations, CAPA and change control.
- Ability to set up processes, manage documentation and ensure compliance.
- Demonstrated expertise in managing validation and qualification activities.
- Responsible, structured and decisive approach.
- Natural authority, ability to lead a team and communicate internally and externally.
- Czech native speaker
- English level B2+.
Job-offer
An exciting position in a dynamic organization with an attractive remuneration package and opportunities for learning and development.
Application
Please fill out the form to submit an application.
About us
Symeres is the leading mid-sized transatlantic contract research organization for drug discovery and development needs. With over 700 highly educated scientists and professionals in six locations in Europe and two in the USA, we offer best-in-class solutions for drug discovery and drug development, from small- to medium-sized molecule hits. We are large enough to matter, and small enough to care. Our services span across early stage hit finding all the way to the delivery of your early clinical drug substance API. Making molecules matter. Together.
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