QA SENIOR MANAGER (Sant Andreu de la Barca)

QA SENIOR MANAGER (Sant Andreu de la Barca)

13 ago
|
Almirall
|
Sant Andreu de la Barca

13 ago

Almirall

Sant Andreu de la Barca

We’re building the future of medical dermatology by focusing on unmet patient
needs and giving people the space to think independently, take ownership and
make an impact that matters.

Our purpose is simple: to transform patients’ lives by addressing real needs. We
work with care, act with courage, keep things simple and focus our innovation
where it makes a difference.

Recognised as a Top Employer in Spain since 2008 and in Germany since 2025, we
continue to invest in an environment where people can grow and move forward.

If you care differently, you belong here.

Mission

Responsible for the maintenance, development and continuous improvement of the
Almirall GVP Quality Management System ensuring compliance with applicable
regulations and guidelines.

Functions and responsibilities

1. To maintain the Quality System for Pharmacovigilance activities in
accordance with Almirall policies, ICH guidelines, EU GVP modules, and other
relevant regulatory requirements with the support of the Almirall Corporate
Patient Safety department.

2.



To set up the GVP risk-based audit plan and program and perform (or
coordinate and oversee when outsourced) audits at affiliates, partners,
CROs/vendors as well as internal audits to the Almirall Pharmacovigilance System
on a regular basis.

3. To report the observations arising from audits (or any other quality
issue) to applicable management and follow-up on the significant findings until
completion.

4. To lead the preparation and management of inspection by Competent
Authorities and audits by third parties to Almirall by developing an inspection
readiness plan.

5. To edit, review and approve the procedures and any other key documents
ensuring that they are aligned and compliant with the applicable regulation
applicable to Drug Safety.

6. To select, coordinate and oversee the outsourced QA activities
applicable to pharmacovigilance (e.g. audits, mock inspections, training).

7. Involvement in due diligence of development products

📌 QA SENIOR MANAGER (Sant Andreu de la Barca)
🏢 Almirall
📍 Sant Andreu de la Barca

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