Quality Manager/Lead, Responsable de Calidad o Responsable Técnico

MARIA MOSQUERA SUAREZ ********@*****.** * *

MARIA MOSQUERA SUAREZ

004*-****-*** 132 ********@*****.** https://www.linkedin.com/in/maria-mosquera-suarez Henley on Thames RG9 1NB

QUALITY ASSURANCE-COMPLIANCE

Dedicated and qualified Pharmacist with over 15 years of pharmaceutical industry experience. Comprehensive knowledge of Good Manufacturing Practices (GMPs), Good Distribution Practices (GDPs) and Good Clinical Practices (GCPs). Provides safe and effective quality products to patients based on the expertise gained in clinical trials, manufacturing, releaseand distribution of medicinal products. KEY SKILLS

Qualifications: Life Sciences degree, strong working experience in multinational pharmaceutical companies and member of a professional body. Eligible as a Responsible Person/Pharmacist (RP).

Managerial skills: Excellent stakeholder and people management skills. Experience in directing and growing teams.

Regulatory inspections: Experience with Board of Health communication and hosting external inspections.

Change management: Experience in management of regional or global projects using tracking systems in change controls.

Drug development: Experience in supervising clinical trials for optimal data quality and integrity.

Communication skills: Strong verbal and written communication skills in both English and Spanish. EXPERIENCE

Pfizer, Hurley, UK

Clinical Scientist Manager 2022 - Present

Provides medical and scientific technical expertise and support for global Phase 1-4 clinical studies within Vaccine Research and Development (VRD). Works collaboratively with Sr. Manager and/or Lead Clinical Scientists, and Study Clinicians in moderately complex tasks. Pfizer, Hurley, UK

Senior Associate Quality Operations 2016 - 2022

Drove continuous improvement within the Pharmaceutical Quality Management System (QMS) for the EU Release Sites. Ensured compliance to applicable Marketing and Manufacturing Authorisations, local and global Health Authority regulatory requirements and Pfizer policies, procedures and standards. Role included but not limited to Regulatory Inspections and Audits by vendors, License Management, New Product Launches, Change Controls, Quality Management Review, Quality Risk Management, Deviations, Corrective and Preventative Action (CAPA), Effectiveness Check (EC), Internal Audits, QP Declarations, D- Declarations, Product Quality Reviews (PQRs), Documentation and Training. Deputised for the Compliance Manager.

Led the Brexit project - On behalf of the EU Release Sites, led this cross-functional project impacting over 50 Marketing Authorisations (MAs) in an aggressive timeframe. Key role was to work with the Regulatory and Artwork teams on regulatory submission dossiers. Created the relevant QP Declarations, D-Declarations and Product Change Forms for the variation submissions.

Led New Product Launches (NPLs) in Europe - Led the launch of over 20 new products aligning both global and European processes and simplifying procedural requirements. Continuously communicated with the leadership team.

Led Organising for Growth project – Supported the transfer of products between Pfizer sites affecting regulatory dossiers.

MARIA MOSQUERA SUAREZ ********@*****.** 2 3

Led Change Controls (CCs) – Functioned as the Site Compliance Network Member and performed impact assessments for quality, regulatory and artwork impact. Also managed global change controls when multiple sites were impacted by the change.

Led the implementation of Global SOPs (GSOPs) - Created a protocol to implement the adoption of global procedures and managed the integration into the QMS of the EU Release Sites.

Led the deployment of the new electronic archiving system (Gnosis) - Singlehandedly managed the implementation of Gnosis. Created a new procedure to formalise its use and trained all colleagues. Pfizer (previously known as Hospira), London, UK

Pharmacist Team Leader 2012 - 2016

Responsible Pharmacist (RP) for the site, led and managed the release team (7 direct reports) in the Aseptic Compounding Unit. Led the implementation, maintenance and development of the Quality Management System (QMS). Contributed to the key areas by ensuring risk identification and the effective maintenance of the Specials Manufacturing License and corporate requirements.

Resource management - Provided training, coaching, appraisals, performance reviews, dealt with disciplinary cases and associated resource activities to achieve team, business unit and organizational goals.

Manufacturing and Product release - Ensured the adherence to the quality standards from the Medicines and Healthcare Products Regulatory Agency (MHRA), Good Manufacturing Practices

(GMPs), Eudralex, International Council for Harmonisation (ICH), ISO 9001 for Quality Standard, General Pharmaceutical Council (GPhC), Corporate Quality Manual, Standard Operating Procedures

(SOPs) and Good Documentation Practices (GDPs).

Quality Management System (QMS) – Led regular quality management reviews and Key Performance Indicators (KPI). Evaluated trends, identified actions and promoted continuous improvement.

Documentation and Data Management - Implemented GDP and the ALCOA+ principles.

Deviations/Exception Reports (ER), CAPAs ECs - Reviewed and approved quality records in Track Wise and Veeva/Vault software.

Change Control management - Led risk assessment of the proposed change, action plan, execution, and documentation.

Inspection/Audit management - Ensured inspection readiness for regulatory authorities, corporate, internal self-inspection and third-party audits.

Complaints and Adverse Drug Reaction (ADR) - Performed risk assessments, investigations, root cause identification, reporting and documentation.

Validation, calibration and maintenance - Managed protocols and reports.

Environmental Monitoring (EM) - Overseen the Heating, Ventilation and Air-Conditioning (HVAC) systems in the manufacturing facilities.

Vendor Assurance (VA) - Worked with suppliers/providers to ensure all starting materials met requirements and expectations.

RP checks and Controlled Drugs (CDs) – Ensured alignment with local regulations. Baxter Healthcare Ltd, Northampton, UK

Pharmacy Manager 2006 - 2012

Led and managed the pharmacy team in the National Supply Chain (8 direct reports). Supplied safe and effective quality products and services to over 100 customers/hospitals. Aided in the implementation, maintenance and development of the Quality Management System (QMS). Supported the preparation and coordination of Product Quality and Good Distribution Practice audits and inspections towards the effective maintenance of the Wholesale Distribution Authorisation (WDA). MARIA MOSQUERA SUAREZ ********@*****.** 3 3

Luis Tapia Pharmacy, Madrid, Spain

Pharmacy Manager 2003 –2006

Dispensed Prescription Only Medicines (POMs), Pharmacy (P) and Over the Counter (OTC) medicines directly to patients.

Gregorio Ramos Torio Pharmacy, Galicia, Spain

Relief Pharmacist 2001 –2003

Dispensed Prescription Only Medicines, Pharmacy and OTC medicines to patients. EDUCATION AND TRAINING

Pharmacy Degree, M Pharm, University Santiago de Compostela, Spain General Pharmaceutical Council (GPhC), UK, Registration Number 2062599 NVQ Level 3 in Management

Six Sigma Green and Yellow Belt Certificates

CAPA and Track Wise Ownership

Master Trainer in CAPA Quality Investigation

Master Trainer in Facilitation Skills

Internal Auditor Qualification

Fundamentals of Clinical Trials

Management Essentials and Human Resources (HR) Policies and Procedures Advance English Certificate approved by Cambridge University TECHNICAL SKILLS

Continual Professional Development (CPD) up to date

Proficient in MS (Word, Excel, PowerPoint, and Visio) and electronic documentation/data control systems such as Track Wise, Veeva/Vault, Oracle/Inform and JReview

First Aid at Work

ADDITIONAL INFORMATION

Languages: English (over 15 years living in the UK); Spanish (native language); Galician Full driving licence

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