Sr. Director Pcru Quality Group Lead

Do you want to be part of an international, innovative, world-class organization committed to putting patients first? The Pfizer Clinical Research Unit (PCRU) provides study-related clinical care and monitoring of the participants in our Phase 1 clinical trials. PCRU runs studies in Healthy Participants to deliver high quality Pfizer clinical pharmacology and early clinical development portfolio. Clinical research truly make a difference as we strive for breakthroughs that change patients’ lives.

Location: Brussels, Belgium

About the role

The Pfizer Clinical Research Unit (PCRU) Quality Group Lead is the single point of accountability for the strategic direction and leadership of ongoing operations of the global quality framework of the PCRUs. This quality framework will set the stage for an overall quality culture and encompass robust SOP and training.

Main responsibilities
- This role provides leadership and drives the strategy for the activities related to Quality, Inspection Readiness, and Audit Response management for the PCRUs globally and will serve as a point of escalation for quality issues arising within the PCRUs.
- This role also has overall accountability to lead the development and harmonization of the PCRU SOP and Training Program, in collaboration with PCRU sites leadership, including the implementation of both global and local procedures and the associated end to end training and ongoing learning needs of the PCRUs.
- The individual will sit as part of the PCRU Leadership team and provide the global strategy and oversight of the PCRU QMS & GCP Quality Performance function to proactively mitigate GCP risk, and control and improve end-to-end process, study, and site quality.
- This position will be fully accountable for the Quality Risk Management Process, including the associated tools and resources, and will be accountable for ensuring adherence to emerging global GCP Requirements in his/her area of responsibility.
- The individual will also provide the global strategy, oversight and business performance for the Global PCRU quality framework.
- This is a people manager role, responsible for both colleagues and contracted resources as required across countries. Responsibility for 6-10 direct reports.

About you
- Communication - Superior verbal and writing skills. Ability to communicate effectively and appropriately with internal and external stakeholders both internally and externally. Experience presenting to large non-science populations. Fluent in English (C1-C2) and in one of the national Belgian Languages (French or Dutch).
- Experience of directly managing a team with direct accountability for performance/or with a direct customer relationship responsibility
- Exceptional interpersonal skills, including ability to persuade, negotiate, and moderate conflict
- Well-developed strategic planning, observation, analytical operational execution and problem-solving skills
- Demonstrated ability to manage complex projects and cross-functional processes required
- Preferred knowledge of clinical pharmacology and exploratory clinical research processes and regulatory requirements (GCP and GMP).

What do we offer?

Innovative company Pfizer has a pipeline full of innovative medicines for a variety of conditions. As a Pfizer colleague, you'll have the opportunity to maximize the impact of medicines for patients in a variety of ways. In short, you make a real difference.

Development opportunities We are always looking for top talent. We believe you will never stop learning and there will always be a new opportunity for your development. That is why we have broad opportunities in the Dutch organization. There are regular opportunities for training or to gain experience in a different field or even advancement to an international position.

A culture where you can be yourself We are a large, international organization with people from all over the world. At Pfizer everyone should be able to be themselves, that's what we strive for and live by.

Work/life balance At Pfizer, we know that if you really want to make an impact on people's lives, it's important that your people are at their best. That's why we offer our colleagues good working conditions, such as an appropriate salary and opportunities to work from home. Working a lot of overtime is not the norm for us. We also believe that work and having fun should go hand in hand. That's why, for example, you can participate in all kinds of activities outside of work.

Are you interested?

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

LI-PFE
- Pfizer discovers, develops, manufactures and distributes medicines and vaccines. Pfizer wants to contribute to better health and wellness for everyone, at every stage of life. Pfizer works with the government and other health partners to provide quality and accessible healthcare. The patient is ce