Head Of Quality & Qp

Head of Quality & QP

Reach your career goals with Eirgen Pharma, your future could be here

Would you like to be part of a company that has the courage, innovation, and capability to improve
and enhance patient lives across the globe?

Eirgen was founded in 2005 and since then we have continually grown and now employ over 180
employees at our site in Waterford. Our strengths lie in our capability to rapidly introduce new
products and add additional volume to existing products - ensuring supply for new product launches
and expanding market opportunities.

What makes us different is that while we continue to grow our business we have still maintained that
small company feel to our culture which enables us to ensure that our employees are always front
and centre in everything we do. By creating a progressive and dynamic working environment, where
hard work and enjoyment aren’t mutually exclusive, we have created a high performing, people-
centric culture which allows us to work in an environment where the focus is always on ensuring that
the patient comes first.

About the Job
You will lead and manage the strategic and operational performance of the Quality & Regulatory

Department and ideally also carry out the role of the Qualified Person.

You areas of responsibility will include:

Senior Leadership :

• Participate as part of Campus Senior Leadership team in effective running of the business

• Along with Head of Quality at OPKO Health Miami to be responsibility for Corporate Quality

oversight at OPKO Health and its subsidiaries

• Drive Communication, Company Culture, Vision & values, Goals and Corporate interface

• Financial governance - oversee the preparation and management of department budgets to

timelines, anticipating resources and allocations required

• Maintain and communicate site performance metrics

• Provide leadership, drive technology and delivery strategy

• Ensure performance, guidance and coaching is managed

• Participate in senior leadership meetings and Tiered Meetings, including presenting on work

and facilitating discussion with the senior team on a regular basis

QP Batch disposition:

• Certification as Qualified Person (Q.P.) and batch release as defined in Article 51 of Directive

2001/83/EC or Article 55 of Directive 2001/82/EC of sterile and non-sterile Human and
veterinary clinical and medicinal bulk and packaged product

Functional Responsibilities

• Responsibility for the oversight of all Quality Assurance, Quality Systems & Quality Control for

the company.

• SOPs, Annual reviews, Quality Agreements, License Database, and Dossier management

Regulatory strategy for Eirgen/OPKO products and in collaboration with co-development
partners where applicable

About you

You have strong technical expertise and a proven track record as a strategic and collaborative leader
at senior management level. Qualified to a minimum of primary degree in a scientific or engineering
discipline with Quality Management you possess a Post Graduate Diploma or Masters ideally in
Pharmaceutical Technology/Quality Systems. Qualified Person capability is also a requirement.

You have at least 10 years’ pharmaceutical experience, preferably within the Quality Systems and
Quality Assurance field of medicinal product manufacture, while Qualified Person capability is very
advantageous. Experience with pharmaceutical packaging, oversight of Contract Manufacturing and
Contract Development Manufacturing Organisations is preferable.

You possess knowledge of EU and FDA cGMPs, guidelines and also best practices have a good
compliance record and experience preparing, facilitating and hosting regulatory inspections and
customer audits, while prior experience of electronic document management systems is

advantageous along with Project management skills.

You will draw from your many skills such as your ability to influence, form positive collaborative

relationships, continuous improvement mindset and problem solving ability.

Working at Eirgen – What to expect

At Eirgen, we have developed a diverse, people-centric, high performance culture where people are

enabled to achieve their potential.

If you are working at Eirgen, then we think you’ve got something special. Our employees are high-

performing and work as part of a cohesive team, they are dedicated people who are driven to

succeed and are rewarded with competitive salaries and an attractive range of benefits including

opportunities for career progression and continuing education.

Apply for the above role by sending your CV to opportunities@Eirgen.com including the job title in

the subject.

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