Job Title: Head of Quality/RP - Ireland
Location: Dublin
About ADVANZ PHARMA
ADVANZ PHARMA is a global pharmaceutical company with the purpose to improve patients’ lives by providing the specialty, hospital, and rare disease medicines they depend on.
Our ambition is to be a partner of choice for the commercialisation of specialty, hospital, and rare disease medicines in Europe, Canada, and Australia. In line with our ambition, we are partnering with innovative biopharma and pharmaceutical development companies to bring medicines to patients.
Headquartered in London, UK, we have c700 employees based across more than 20 countries, including key countries in Europe, the US, Canada, and Australia. Our Centre of Excellence in Mumbai, India, as well as an established global distribution and commercialisation partner network complement our global operations.
ADVANZ PHARMA’s product portfolio and pipeline comprises innovative medicines, specialty generics & biosimilars, and originator brands. Our products and pipeline cover a broad range of therapeutic areas, including hepatology, gastroenterology, anti-infectives, critical care, endocrinology, CNS, and, more broadly, rare diseases.
We can only achieve our ambition with the passion of our dedicated and highly qualified people, acting in line with our company values of entrepreneurship, speed, and integrity.
About the Role
• Leadership and management of the GDP Compliance team and consultant RPs
• To act as a named operational Responsible Person and Designated Person under the site wholesale distribution authorisation(s) and Active substance registration(s)
• To execute Responsible Person duties as per the EU Guidelines on Good Distribution Practice (2013/C 343/01), (2015/C95/01) and relevant local guidelines
• Maintain effective and compliant Quality System
Key responsibilities:
• Leadership and mentoring of the GDP Compliance and Contract RP teams
• Responsible for Commercial Quality strategy and execution including WDA strategy, resourcing, and maintenance
• Establish and maintain systems, processes, and resources in accordance with business and GxP requirements for all areas of responsibility
• Establish quality objectives and KPIs (including reporting) for areas of responsibility
• Oversee and ensure readiness for inspections by Health Authorities associated with WDAs and ASR
• Lead and support interactions with Health Authorities
• Lead major quality related incident resolution and provide guidance and solutions to technical and quality related issues
• To oversee systems and approve related documents (as necessary) for Deviations, Complaints, CAPA, Audits, Self inspection, Change Control, Customer Returns, Stock transfer request forms, Customer and Supplier Bona fide checks and Management Review
• Fulfilment of the requirement of GDP guidelines and Routine Duties of a Responsible Person/ Responsible Person for Import/ Deputy Responsible Person (as appropriate) as laid down in EU GDP guidelines for Medicinal products for human use, EU GDP guidelines for Active substance and relevant local regulatory requirements
• Maintain an open team culture focused on continuous improvement and talent development
• Responsible for identifying own training and development needs and ensuring Continued Professional Development
• Actively participate as a member of the Quality Leadership team
• Budgetary responsibility for relevant areas and ensure adherence
• Other activities as may be required, at the discretion of management
About You
We are looking for highly motivated individuals who are passionate about making a meaningful difference to patients’ lives.
Qualifications:
Minimum Bachelor’s Degree in Chemistry, Pharmacy, Life licenses or equivalent
Eligibility to fulfil the requirements of HPRA Good Distribution practice in respect of a Responsible Person/Designated Person
Experience & Competences
Minimum 5 years’ experience of working in a similar role within a pharmaceutical company.
Able to travel within Europe, or globally for Quality and/or Commercial and/or Technical project activities
Capable of working to deadlines & remain calm under pressure
Proven ability to organize and prioritize multiple tasks
Ability to work on own initiative & juggle priorities
Ability to work effectively as part of a team
Knowledge & Skills:
Proven managerial experience and ability to develop staff
Excellent communication skills, both oral and written, to include senior management in third party suppliers
Well organised with logical & methodical approach to work
Sound problem solving skills
Good organisation & time management skills
Personal Qualities:
Professional, methodical approach to work with ‘can-do’ attitude
Even tempered, positive persona, approachable
Helpful & flexible with strong team spirit
Why ADVANZ PHARMA?
The success of any company is driven by its people, and we are no different.
At ADVANZ PHARMA, we believe in empowering our people to be entrepreneurs and embrace challenges to enable personal and company growth in an agile and fast-paced environment. We strive to do that inclusively and responsibly, treating all employees with integrity whilst rewarding outcomes and impact.
Our teams are made up of people from all walks of life and backgrounds. We thrive in an environment where uniqueness is celebrated, but we are all united by the same passion to help improve patients' lives by providing and enhancing the specialty and hospital medicines they depend on.
As a business, we like to tap into new ideas and fresh perspectives. So, if you join us, you’ll be empowered to own your work, explore new possibilities and make things happen.
But there’s more to you – and us – than just work, which is why our culture, vision and values are so high on our agenda. We believe in gender equality and actively encourage women into senior roles – we have an active ADVANZ PHARMA Women’s Network; almost 40% of our managers are women.
We work hard to recognise and reward talent, and we actively promote from within - last year, approximately 25% of our people across the company achieved promotions. In addition, we recognise talent with our annual Impact Awards, in which our top performers are rewarded for their hard work and dedication.
We offer flexible, agile working options, and you will also enjoy a highly competitive salary and benefits package.
To join us on our exciting journey, Apply now! *
*Please include a CV and Cover letter.
ADVANZ PHARMA's Commitment to Equal Employment Opportunities: Our teams are made up of people from all walks of life and backgrounds. We thrive in an environment where uniqueness is celebrated. ADVANZ PHARMA is committed to providing equal employment opportunities for all employees and prospective employees without regard to race, color, religion, sex, age, national origin, ancestry, sexual orientation, marital status, disability, or other protected classifications to the extent required by applicable laws. In all instances, the company will continue to comply with all local laws governing employment practices. In addition, the company will make reasonable accommodation for any applicant or employee with a disability, both during the application process and on the job, whenever possible.