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Senior Quality Assurance Manager PV & Clinical

Barcelona, Spain·Operations·Added 14 days ago

Ferrer

37 open roles

What they offer

  • Hybrid

    Office and home days — the ad has the split.

What they ask for

  • Have the right to work in Spain

    Ferrer doesn't mention sponsorship in the ad.

  • Speak native-level Spanish

    Listed as a requirement in the ad.

  • Work in English

    English is required, per the ad.

  • Be near Barcelona for hybrid days

    No relocation package mentioned.

  • Have 5+ years of experience

    Senior-level role.

About the job

This job was automatically translated to English, .

Lead the supervision and assurance of regulatory compliance under the highest quality standards. You will be the guarantor of internal procedures, Good Clinical Practices, and Good Pharmacovigilance Practices, driving a culture of continuous improvement and operational excellence within the Quality System.

What you'll do

  • Ensure the implementation of the Company's Strategic Plan within your scope of action.
  • Define, implement, and maintain the Corporate Quality System, incorporating initiatives for continuous improvement.
  • Define, develop, implement, and monitor "Key Quality Indicators" (KQIs) that allow measuring the proper functioning of the Quality System.
  • Create, review, and/or approve Standard Operating Procedures (SOPs) and other controlled documents, for the performance of functions within the Quality department and operational areas within the scope of application, and ensure their updated and current status.
  • Establish a periodic schedule for quality system reviews to evaluate its suitability, adequacy, effectiveness, and efficiency.
  • Lead and empower the team to achieve objectives, developing capabilities, driving performance, and promoting a culture of collaboration and continuous improvement.
  • Evaluate, as needed, the impact on the system of new developments and changes in regulations and applicable legislation, ensuring regulatory compliance.
  • Contribute to cross-functional strategic Company and Development projects, ensuring compliance with applicable GCP/GVP regulations.
  • Manage Change Controls, ensuring traceability and correct implementation of said changes in compliance with data integrity practices.
  • Act as a liaison between/with functional units and collaborators to promote standardization, improve communication, and enhance the efficiency of quality systems through cooperation in line with the department's strategy.
  • Ensure that decision-making is carried out based on scientific criteria supported by Risk Management tools, as appropriate.
  • Implement, manage, and maintain the deviation management system and Corrective and Preventive Actions (CAPAs).
  • Participate in internal and external audits and inspections.
  • Manage the specific training and development of the members of their team as well as those from other areas involved in related activities.
  • Plan and draft the applicable Annual Work Plans for the team linked to activities subcontracted by Ferrer, including Subsidiaries. Subcontracted activities are understood to include all Suppliers that provide materials / services to Ferrer's pharmaceutical plants, as well as third-party manufacturers and partners / distributors.
  • Plan, schedule, conduct, and report audits in the GCP/GVP scope related to activities subcontracted by Ferrer, including Subsidiaries.
  • Coordinate, draft, and review Technical Quality Agreements (Technical Quality Agreements).
  • Review and approve deviations and complaints related to materials, services, and/or products linked to activities subcontracted by Ferrer.
  • Carry out an advisor role and act as a liaison with third-party companies on topics related to Quality Systems, GCP/GVP regulations, and regulatory compliance.
  • Define and maintain the system for the Qualification and Monitoring of Ferrer's subcontracted activities, including related Risk Management activities at the corporate level (including support to Subsidiaries).
  • Coordinate and conduct Due Diligences within the scope of GCP/GVP.
  • Coordinate and ensure the evaluation, risk management, and periodic monitoring of activities subcontracted by Ferrer, including Subsidiaries.
  • Management and coordination of technical documentation issued by third-party companies and applicable to the scope of Ferrer's activities.
  • Coordinate and provide support to the Quality System of Subsidiaries, as well as exercise the advisor function on GCP/GVP topics.

What we're looking for

If you are an empathetic, humble, curious and optimistic person, Ferrer is your company!

You will be the best in this role if you match:

  • Bachelor's or Master's degree in Pharmacy, Biology, Medicine, or a related field.
  • Minimum of 5 years working in regulated environments.
  • Previous experience managing work teams.
  • Advanced English level.

What you'll get

  • Make a positive impact on society
  • Opportunity to participate in volunteering activities.
  • Corporate culture based on trust and responsibility.
  • Hybrid and collaborative working model.
  • Development opportunities and continuous learning.
  • Meal vouchers in case of a split shift.
  • Flexible compensation
  • People support plan (psychological, legal and financial counseling).

Additional information

If you think your profile could be a good fit and you are eager to start an exciting new project, we are waiting for you!

At Ferrer we guarantee equal treatment and opportunities in hiring, avoiding prejudice and stereotypes for any reason in the processes of access to the company, considering only objective criteria such as professional skills, academic qualifications and work experience.

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