Quality Control Projects Supervisor (Bio)

mAbxience; Barcelona; Presencial; EUR 50.000 - 70.000; Jornada completa

Descripción de la vacante

A leading biotech company in Spain seeks a Quality Control Projects Supervisor to oversee all biochemical activities related to new molecules. The ideal candidate will have a Bachelor's in Biology or Biotechnology, fluency in Spanish and English, and 5 years of industry experience, with 3 years in a supervisory role. Responsibilities include implementing quality systems, managing teams, and ensuring compliance with standards. This position may require occasional travel and offers a dynamic work environment.

Formación

• 5 years in pharmaceutical/biotech industry; 3 years in similar position.
• Fluent in Spanish and English.
• Knowledge of biochemical techniques, validations, and audits.

Responsabilidades

• Implement and maintain biochemical activities related to new molecules.
• Coordinate organization within area and designated technicians.
• Collaborate in R&D for analytical methods adjustment and implementation.
• Prepare and review documentation for qualification and validation.

Conocimientos

Management of work teams

Organization skills

Customer oriented

Communication skills

Proactivity

Flexibility

Educación

Bachelor of Sciences in Biology or Biotechnology

Herramientas

LIMS

SAP

TrackWise

Descripción del empleo

Quality Control Projects Supervisor (Bio)

From mAbxience, a company specialized in the development and manufacture of biosimilar medicines.

All relevant skills, qualifications and experience that a selected candidate will need are listed below.

Plant location: León.

General Responsibility

• Implementation and maintenance of all biochemical activities related to new molecules.
• Coordinate day‑to‑day organization within area and designated technicians and analysts.
• Create and maintain a documentation system for qualification and validation protocols related to the area employee is responsible of.

Specific Responsibilities

• Projects follow up, using a suitable tool easy to follow.
• Collaborate with R&D in design, adjustment, implementation, transfer of analytical methods.
• Collaborate with MSAT in process validation protocols of new molecules.
• Validation and transfer activities of analytical methods: Ensure the new methods are correctly implemented in commercial departments and give support to them when needed.
• Manage reference standards.
• QPIs management related to QC projects: Review / manage changes in SOPs, Specifications, PTs, and applicable Training Guides.
• Prepare the technicians' shift schedule, if applicable, based on the department's needs.
• Assist in the preparation / review of dossiers, BLA, and deficiency letters.
• Control and archive documentation related to qualification and validation.
• OOS investigations and deviations management: Carry out activities for formation and training required for personnel from validation QC.
• Constantly keep themselves updated on progress of EU and USA standards so as to maintain GMP compliance.
• Provide help in start‑up, qualification / validation of equipment involved in QC labs.
• Manage change control documentation and CAPA.
• Provide technical support during audit courses (internal and external audits).
• Propose the acquisition of necessary resources (equipment, systems, personnel) for the tasks.
• Collaborate in the preparation of CAPEX, OPEX, and Head Count.
• Identification of needs and possibilities for improvement in the area.
• Manage and use computerized systems of general management (LIMS, SAP, TrackWise, etc.) so as to issue and control documents and analytical records of their responsibility.

Requirements and Personal Skills

• Education: Bachelor of Sciences in Biology or Biotechnology preferred.
• Languages: Fluent Spanish and English.
• Experience: 5 years in pharmaceutical/biotechnological industry; 3 in similar position.
• Specific Knowledge: Biochemical techniques, Validations, CMO, Investigations, Audits.
• Travels: Available for sporadic travelling.
• Personal Skills: Management of work teams, organization skills, customer oriented, communication skills, proactivity and flexibility.

mAbxience is committed to equal opportunities. We do not discriminate against any person on the grounds of ethnicity, religion, age, sex, nationality, marital status, affective or sexual orientation, gender identity or expression, disability, or any other personal or social circumstance.