Senior QC Manager – Biologics/ATMPs (GMP)

Randstad Portugal; Braga; On-site; EUR 65,000 - 90,000; Full time

Benefits offered by this job

Competitive salary package

Career advancement opportunities

Diverse and inclusive environment

Accommodations in application/interv

Job summary

Randstad Portugal is seeking a Quality Control Manager to oversee the QC laboratory operations in a GMP environment. The role involves directing testing of starting materials, in-process samples, and finished biologics, and driving data integrity and OOS investigations.

The ideal candidate will have 6+ years in industrial QC within biotech/pharma, plus 2+ years of supervisory experience, and strong proficiency in Flow Cytometry, ELISA, and potency assays. English fluency is essential.

Qualifications

• Bachelor’s or Master’s degree in Biochemistry, Chemistry, Biology, Pharmaceutical Sciences, or a related scientific discipline.
• Minimum 6 years of hands-on Quality Control experience in an industrial pharmaceutical or biotechnology setting.
• Minimum 2 years of proven supervisory or team leadership experience within a GMP industrial manufacturing environment.
• Technical proficiency in analytical methods tailored for biologics/ATMPs, including multi-color Flow Cytometry, ELISA, cell-based potency assays, and multiplexing assays.
• Solid experience in standard pharmacopeial testing and non-compendial assay development, optimization, and validation.
• Practical application of GMP regulations, data integrity standards, and scientific rigor in OOS investigations and technical troubleshooting.
• High autonomy, emotional maturity, decision-making under operational pressure, and strong interpersonal and mentoring abilities.
• Full professional fluency in English (written and spoken).

Responsibilities

• Supervise routine and non-routine testing of starting materials, in-process samples, bulk, and finished biological products in compliance with SOPs and GMP standards.
• Oversee the implementation, optimization, and continuous update of QC procedures, inspection methods, and departmental SOPs.
• Review and approve analytical test data and reports, ensuring prompt identification and technical investigation of OOS results.
• Ensure full qualification, calibration, and preventative maintenance of laboratory premises, state-of-the-art equipment, and analytical instrumentation.
• Lead, mentor, and resource-plan for a high-performing QC team, establishing departmental KPIs aligned with business goals.
• Drive follow-up actions and timely resolution of findings from internal audits and external regulatory/client inspections.

Skills

Quality Control leadership

GMP knowledge

Analytical methods (Flow Cytometry, EL

Education

Bachelor’s or Master’s in Biochemistry, Chemistry, Biology, Pharmaceutical Sciences

Tools

Flow Cytometer

ELISA

Cell-based potency assays

Multiplex assays

Calibration & maintenance

Job description

Randstad Portugal is seeking a Quality Control Manager to oversee the QC laboratory operations in a GMP environment. The role involves directing testing of starting materials, in-process samples, and finished biologics, and driving data integrity and OOS investigations.

The ideal candidate will have 6+ years in industrial QC within biotech/pharma, plus 2+ years of supervisory experience, and strong proficiency in Flow Cytometry, ELISA, and potency assays. English fluency is essential.