Local Quality Assurance Manager (GDP) Iberia

Title:

Local Quality Assurance Manager (GDP) Iberia

Company:

Ipsen Pharma SA

 

About Ipsen:

Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation.

 Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company’s success. Join us on our journey towards sustainable growth, creating real impact on patients and society!

For more information, visit us at https://www.ipsen.com/ and follow our latest news on LinkedIn and Instagram.

Job Description:

At Ipsen, we believe that patients cannot wait to receive the right treatment, support, and awareness they need. Therefore, our goal is to make a difference by significantly improving the health and quality of life of patients and providing them with effective therapeutic solutions for unmet medical needs through differentiated and innovative medicines in Oncology, Neurosciences, and Rare Diseases.

The patient is at the center of everything we do, and we also care about our employees because they are the ambassadors and the ones who truly make a difference. We attract and develop bold, agile, and entrepreneurial people who take full responsibility for their decisions; leaders drawn to the purpose of making a direct impact through their work on people's lives.

We offer employees a wealth of rewarding challenges and growth opportunities, and the chance to contribute within a constantly moving organization, an organization that truly changes the game.

At Ipsen, we are looking for a  Local Quality Assurance Manager (GDP) Iberia , based in Barcelona, who, under the direction of the Quality Lead Iberia, will

act as the Quality Assurance Manager function at Ipsen Commercial Operations Iberia (Spain & Portugal) for Good Distribution Practices (GDP) activities.

The Quality Assurance Manager is responsible for the overall management of the Affiliate Quality Management System and quality assurance programs, to foster a strong quality and continuous improvement culture, and thus ensuring that the local license to operate activities meet internal and external requirements (including regulations and Good x Practices), policies and procedures.

Your main responsibilities will include:

Quality Assurance:

• Act as the local quality assurance/quality system representative for the Iberian cluster;
• Establish and maintain Iberian cluster Quality Management System and Quality Assurance activities to ensure compliance with all regulatory and GxP requirements;
• Host/Coordinate audits/inspections on behalf of GDP functions within the  Iberian cluster;
• Local supplier assessment and oversight including QTAs maintenance and local audits conduct;
• Ensure Quality management review and KPIs are established;
• Maintain quality assurance activities for GDP programs/activities;
• Focuses on proactive crisis prevention and supports crisis (QSEB) and CAPA follow-up when needed;
• Drive and support local and global initiatives on continuous quality improvement;
• Drives remediation plan when a product quality or GxP process issue is identified;
• As Product Quality Complaint Manager Iberia, maintain and ensure local Product Complaints and recalls management;
• To control, in conjunction with local distributor(s), the reception, warehousing and distribution of the Ipsen products;
• To ensure that distributors comply with Good Distribution Practices (in particular cold chain and transportation);
• Integrate global/corporate and Iberian cluster, as applicable, quality needs and priorities, including representing the Affiliate at the Ipsen Global Quality Forum;
• Foster quality culture by encouraging best practices and a high performing “quality beyond compliance” culture, both from procedural and patient/customer centricity perspectives;
• Contribute strongly to building quality and compliance through governance and education;
• Participate on regulatory intelligence process and, where necessary, escalate with technical expertise, assessment and solution proposals;
• Ensures comprehensive training program covering GDP activities;
• Ensure the Iberian cluster, self-inspection, GDP audit readiness; business continuity, change control, Deviations and CAPA management systems and activities are in place and implemented to cover GDP processes;
• Conduct and/or host risk assessments, self-inspections, regulatory inspections, audits, mock-recalls and should the situation arise, to participate in Product Recall Management;
• Support local product release activities; Facilitate troubleshooting; support any OOS, if applicable;
• Quality interface for local Distribution partners;

Collaboration with other Departments

• Proactively advocate for quality processes across functions
• Proactively identify areas for process improvement and mediate cooperation cross-functionally to effect and implement the Quality System;
• Contribute towards stakeholder value by providing quality leadership and operational input towards affiliate strategic and tactical activities
• Strengthen the risk management culture and support the update of the IPSEN Risk register;

Communication

• To respect and apply the company rules (especially the confidentiality ones) and strategy in communication with media, authorities and health professionals;
• To maintain membership of societies and professional organisations of interest to the company, according to local legislation and the Group’s guidance;
• To act with all relevant authorities/entities, with a great sense of public relations, having in perspective an increased efficiency and recognition of Ipsen;
• To maintain and develop positive and ethical interactions with relevant authorities;
• To respect and apply the IPSEN ethical code

Who are we looking for?

Requirements:

Knowledge & Experience (essential):

• Experience in a similar position with a proven experience in

• Maintaining Quality Management System in accordance with GDP and Regulations on Distribution of Medicinal Products.
• Auditing
• Host/Coordinate audits/inspections
• Risk assesment

• Approximately 1-2 years in similar position

Knowledge & Experience (preferred):

• Experience in a similar position with a proven experience in

• Maintaining Quality Management System in accordance with GDP and Regulations on Distribution of Medicinal Products.
• Auditing
• Host/Coordinate audits/inspections
• Risk assesment

• Approximately 2-3 years in similar position

Education / Certifications (essential):

•  Degree in Scientific discipline (Pharmacy, Chemistry, or Biological Sciences) with accredited training on GDPs

Education / Certifications (preferred):

•  Master in Pharmaceutical Industry and Postgraduation in Quality, Pharmacovigilance and Regulatory Affairs of the Pharma Industry

Language(s) (essential):

• Expert/fluent communicator in Spanish and English.

Language(s) (preferred):

• Expert/fluent communicator in Portuguese and English.
• Knowledge of Portuguese is a valuable asset

Competencies:

• Drive Purpose:

• Puts values and ethics at the forefront of everything;

• Anchors Ipsen's purpose, mission and commitments to patients and society.

• Manage Complexity:

• Identifies contradictory information/demands/inputs to effectively solve problems;

• Develops and evaluates alternative scenario and solutions;

• Able to identify what truly matters and ruthlessly focus/ prioritize on making decisions with real impact.

• Mindfulness Risk-taking:

• Methodically assesses, transparently shares, and makes risk-informed decisions;

• Empowers to take ownership and accountability.

• Excellence in execution:

• Establishes clarity about the goals, accountabilities, timelines, and next steps; can identify/spot opportunities for real impact on patient and society;

• Able to be focused and performance-driven with clear KPIs

• Plans and aligns effectively (steps, resources, timelines etc.)

• Displays a commitment to best practice sharing and setting

What do we offer?

Joining Ipsen means becoming part of a global biopharmaceutical group focused on innovation and specialized care in three key therapeutic areas: oncology, neurosciences, and rare diseases.

Ipsen's Human Resources policy pays special attention to ensuring that all employees have good working conditions, including a flexible working hours model, training and development programs, as well as social benefits and competitive remuneration based on three main principles: internal equality, external competitiveness, and recognition of work.

TYPE OF CONTRACT

Permanent – Full-time

We are committed to creating a workplace where everyone feels heard, valued, and supported; where we embrace “The Real Us”. The value we place on different perspectives and experiences drives our commitment to inclusion and equal opportunities. When we include diverse ways of thinking, we make more thoughtful decisions and discover more innovative solutions. Together we strive to better understand the communities we serve. This means we also want to help you perform at your best when applying for a role with us. If you require any adjustments or support during the application process, please let the recruitment team know. This information will be handled with care and will not affect the outcome of your application.