Head of Quality/RP

3 weeks ago

Dublin, Dublin City, Ireland Advanz Pharma Corp Full time
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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. We partner with innovative biopharma and pharmaceutical development companies to bring medicines to patients.

Headquartered in London, UK, we have c700 employees 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, covering a broad range of therapeutic areas, including hepatology, gastroenterology, anti-infectives, critical care, endocrinology, CNS, and rare diseases.

We 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.

• Act as a named operational Responsible Person and Designated Person under the site wholesale distribution authorisation(s) and Active substance registration(s).

• 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 an effective and compliant Quality System.

Key Responsibilities:

1. Leadership and mentoring of the GDP Compliance and Contract RP teams.
2. Responsible for Commercial Quality strategy and execution including WDA strategy, resourcing, and maintenance.
3. Establish and maintain systems, processes, and resources in accordance with business and GxP requirements for all areas of responsibility.
4. Establish quality objectives and KPIs (including reporting) for areas of responsibility.
5. Oversee and ensure readiness for inspections by Health Authorities associated with WDAs and ASR.
6. Lead and support interactions with Health Authorities.
7. Lead major quality related incident resolution and provide guidance and solutions to technical and quality related issues.
8. Oversee systems and approve related documents for Deviations, Complaints, CAPA, Audits, Self inspection, Change Control, Customer Returns, Stock transfer request forms, Customer and Supplier Bona fide checks and Management Review.
9. Fulfil the requirements of GDP guidelines and Routine Duties of a Responsible Person/ Responsible Person for Import/ Deputy Responsible Person as laid down in EU GDP guidelines for Medicinal products for human use, EU GDP guidelines for Active substance and relevant local regulatory requirements.
10. Maintain an open team culture focused on continuous improvement and talent development.
11. Identify own training and development needs and ensure Continued Professional Development.
12. Actively participate as a member of the Quality Leadership team.
13. Budgetary responsibility for relevant areas and ensure adherence.
14. 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, including senior management in third party suppliers.
- Well organized 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.
- Helpful & flexible with strong team spirit.

Why ADVANZ PHARMA?

The success of any company is driven by its people. 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, united by the same passion to help improve patients' lives by providing and enhancing the specialty and hospital medicines they depend on.

We actively promote from within - last year, approximately 25% of our people achieved promotions. In addition, we recognise talent with our annual Impact Awards, rewarding our top performers 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: 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.

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