Global Quality Manager - Barcelona, España - Galderma

Galderma

Empresa verificada

Barcelona, España

hace 3 semanas

Publicado por:

Isabel García

beBee Recruiter

Descripción

With a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the leading company solely dedicated to skin and advancing the future of dermatology.

We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration.

Above all, they must be passionate about doing something meaningful for consumers, patients and the healthcare professionals we serve every day.

We aim to empower each employee and to promote their personal growth all the while ensuring business needs are met now and into the future.

Across our company, we embrace diversity and respect the dignity, privacy and personal rights of every employee.

At Galderma, we actively give our teams reasons to believe in our ambition to become the leading dermatology company in the world.

With us, you have the ultimate opportunity to gain new and challenging work experiences and create unparalleled, direct impact.

Job Description:

As the Global Quality Manager (Technical Support Quality Management), you will be accountable for the quality of Galderma's marketed products ensuring they meet the Company's quality standards and comply with the relevant government regulations according to the product applicable classification: cGMP, GDP, ISO, ICH and other relevant regulations and guidance.

Within this role, relying on regulatory, industry and technical expertise, you will be responsible for managing global quality topics at the Galderma corporate level and support Galderma's factories on specific Quality topics.

You will ensure a continued monitoring of the regulations' evolution and the implementation as per given timeframe.

Key Responsibilities

Manage Quality topics at Galderma in partnership with the Head of Global Operations & Commercial Quality and the Galderma SA (GSA) Responsible Person (RP) for trading. This includes managing Technical Quality Agreements with Factories and Trading License requirements.
Define Quality performance & regulatory compliance related goals, objectives and KPIs for Factories. You partner (when appropriate) on Factories' investigation and quality improvements and provide direction to coordinate to Galderma's operational quality management
Promote alignments on some quality related topics to define the way forward to ensure and maintain compliance
Be actively involved in the resolution of critical/major quality issues (causing possible supply issues) and to discrepancies found through audits, inspections, or complaints and their related investigations
Accompany factories towards preventive actions over corrective actions
Notify management of significant quality or regulatory issues that may impact product quality or regulatory compliance

Skills & Qualifications

A minimum of 8 years of relevant exposure in the Pharmaceutical or alternatively Medical Devices/Biopharmaceutical industry and a bachelors preferably in the life science field
A sound knowledge of the applicable regulations for drugs, cosmetics, medical devices such as:
_Medical Device applicable regulations (NF EN ISO 13485; MDSAP; directive 93/42/EC; 21 CFR 820,)_

- _GMP (FDA, EU, ICH, PICs regulations, cGMPs related to all major territories)_
- _GDP regulatory requirements_

A demonstrated knowledge and execution of Quality Operations and the ability to interpret and relate Quality standards for implementation
Ability to work in matrix organization (affiliates, corporate, factories) and capability to negotiate with and manage external stakeholders

What we offer in return

You will be working for an organization that embraces diversity & inclusion and believe we will deliver better outcomes by reflecting the perspectives of our diverse customer base.

In addition, we want to ensure our commitment towards equity and inclusion by offering a competitive and fair compensation with a bonus structure and benefit package.

You become part of a hybrid culture to ensure innovation and collaboration together with the right work-life balance. You will have a development plan, during which a personalized career path will be established, and you join a growing organization that believes in ownership from day one where everyone is empowered to grow and to take on accountability

Process steps

Send your CV in English
If your profile is a match, we will invite you for a first virtual conversation with Talent Acquisition
The next step is a virtual conversation with the hiring manager
The final step is a panel conversation with the extended team