Quality Control Manager (M/F/X)

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

Our client is an innovative, fast-growing Contract Development and Manufacturing Organization (CDMO) specialized in the advancement of cell and gene therapies (ATMPs) and biologics. Partnering with global leaders across the biotechnology and pharmaceutical sectors, the company bridges the gap between cutting-edge research and successful clinical and commercial translation.

Our client is seeking a Quality Control Manager to oversee the operational and technical activities of their Quality Control laboratory. Reporting to the Head of Quality, you will lead technical decision-making and guide a team of specialists to maintain strict compliance in a fast-paced GMP environment.

• 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 Out-of-Specification (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.

• Competitive salary package tailored to market standards and individual experience;
• Opportunity to work in a high-impact, cutting-edge industry (Cell & Gene Therapy / Biologics);
• Dynamic, collaborative, and scientifically rigorous environment with continuous learning and career advancement opportunities.
• We welcome individuals with diverse abilities and experiences. We are committed to ensuring that our recruitment and hiring process meets everyone's needs.
• If you require any accommodations to make your application or interview more comfortable, please do not hesitate to let our recruitment consultants know.

• 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 (sterility, endotoxin, mycoplasma) 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).