Senior Quality Director

hace 2 semanas

Madrid, España PrimeVigilance A tiempo completo

Company Description

We are PrimeVigilance (part of Ergomed PLC), a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance.

PrimeVigilance provides first class support to our small to large pharmaceutical and biotechnology partners maintaining long lasting relationships and has become one of the global leaders in its field. We cover all therapy areas including medical device.

We love investing in our staff by providing an excellent training and development platform. We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved.

**Job Description**:
As a key leader, you will interact with executive leadership, all parts of the PrimeVigilance Quality group, customers, business development, and project teams to drive Quality. You will be responsible for driving quality improvement initiatives across PrimeVigilance.

The Senior Quality Director ensures Pharmacovigilance and Medical Information activities (including supporting computerised systems) are conducted in compliance with applicable legislation, by-laws, regional and local guidelines and standards, in particular rules governing medicinal products in the EU, EU-GVP regulations, the International Conference on Harmonization (ICH), CIOMS and ISO standards and that its clients’ sponsor and marketing authorisation obligations are fulfilled.

Provides leadership and oversight to the development of global quality strategies, provide scientific and quality consultation, and oversee the execution of the global quality strategy. Provide direction for the development of the quality deliverables and provide consulting to clients and the business, as needed.

You will be expected to actively participate in company initiatives and development.
- Drives quality improvement across PrimeVigilance, both within the quality group and in the wider business
- Develops overall strategy and direction for pharmacovigilance opportunities globally in conjunction with Business Unit Leads.
- Acts as a senior-level quality contact for customers, driving customer engagement and proactively identify and resolve quality challenges.
- Participates in customer proposals, Request for Information (RFIs), presentations, proposal defense and Steering Committees.
- Provides quality oversight and governance to project teams, and provide training where necessary.
- Provides quality related training, mentoring and coaching to functional representatives attending bid defense.
- Represents the Company by attending client meetings, speaking engagements, participating in booth exhibitions, etc., and by publishing scientific or industry related articles in industry journals.
- Participates in the development of Standard Operating Procedures (SOPs), pharmacovigilance and medical information tools, training, staffing requirements, etc.
- Interacts with senior management and contributes quality input to other departments, as appropriate.

**Qualifications**:

- Life Science Degree.
- Extensive quality pharmacovigilance experience from a CRO / service provider.
- Detailed knowledge of quality strategy.
- Strong business acumen and proven ability to navigate in a complex matrixed global environment.
- Significant global Line Management experience

Additional Information

We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow.

To succeed we must work together with a human first approach. Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us.

**We offer**:

- Training and career development opportunities internally
- Strong emphasis on personal and professional growth
- Friendly, supportive working environment
- Opportunity to work with colleagues based all over the world, with English as the company language

Our core values are key to how we operate, and if you feel they resonate with you then PrimeVigilance could be a great company to join
- Quality
- Integrity & Trust
- Drive & Passion
- Agility & Responsiveness
- Belonging
- Collaborative Partnerships

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