Quality Director

2 days ago

Dublin, Ireland SK pharmteco Full time

Quality Director
Location: Swords, Co. Dublin, Ireland

ABOUT US?
SK pharmteco is a global Contract Development and Manufacturing organisation (CDMO) with state-of-the-art facilities in Korea, US, France and Ireland. We are part of SK Inc., a Korea company with revenues of $99 billion in 2023. Our mission is to ‘produce and deliver life-changing therapies that improve patient outcomes and save lives’. The SK pharmteco Small Molecule, Europe, facility located in Swords, Co Dublin, Ireland has led the way in the development, scale-up and commercial manufacture of Active Pharmaceutical Ingredients (APIs) and Chemical Intermediates for over 60 years. With a talented workforce, exceptional technical capabilities and facilities we have made some of the world’s most important medicines and continue to do so. Further information on SK pharmteco can be found at www.skpharmteco.com

Current need:
A vacancy now exists for the Quality Director position within SM Europe. This is a senior position, incorporating head of function and membership of the site leadership team. In summary, the Quality Director is responsible for the development, implementation, monitoring and reporting of all aspects of quality control laboratory, quality control systems, quality assurance and regulatory in respect of the Swords site. The Quality Director role is a full-time and permanent role based on-site at Swords, Co. Dublin reporting to the Global Head of Quality.

More specific responsibilities will include the following:

1. Ensure that all aspects of local QA/QC policy meet the requirements of the regulatory agencies.
2. Ensure that all batches are manufactured in compliance with cGMP and meet the strictest quality standards.
3. Exercise sound scientific judgement in relation to batch rejection and the release of batches where serious manufacturing deviations occur.
4. Manage the preparation for regulatory inspections and lead the execution of the regulatory inspections.
5. Management oversight of all aspects of SM Europe change control programs.
6. Management oversight of all aspects of SM Europe deviation and CAPA programs.
7. Ensure that all manufacturing processes, cleaning procedures, equipment and computer systems, shipping studies, analytical methods are validated to the required cGMP standards and are maintained in a validated status.
8. Review and approve the GMP design aspects of major capital projects including new facility construction, facilities upgrades, new manufacturing equipment and support systems.
9. Ensure stability program is effectively managed and meets regulatory commitments.
10. Ensure cGMP training program is adhered to.
11. Review and approve external audit schedule.
12. Review and approval of all annual product reviews.
13. Review and approval of all key site policy documents.
14. Review and approval of all validation master plans.
15. Chair monthly quality council and ensure all follow up actions are adequately addressed.
16. Review all internal audit reports and review and approval of internal audit schedule.
17. Ensure effective implementation of trending system for QC data deviations, internal audits, to ensure effective quality systems and CAPA effectiveness.

Key requirements for this role include:

1. Excellent communication and inter-personal skills. Ability to work in cross functional, multicultural teams.
2. Competencies of Leadership, Communication skills, Teamwork, Problem-Solving and a Commitment to Compliance and Continuous Improvement. Job holder should be responsible for delivering a professional Quality service that is aligned to the strategic objectives of the organisation.
3. As part of the management team, the person will be responsible for all aspects of Quality management and be expected to deliver proactively against the division’s key objectives.
4. The job holder must have a strong background in synthetic organic chemistry and analytical chemistry.
5. A detailed knowledge of chemical manufacturing, materials and technology is required. Knowledge of SAP, materials planning and financial controls. Knowledge of international trade and taxation.
6. The qualified candidate exemplifies our Company values.
7. The ability to contribute positively to the leadership team, in that context acting in support of what is best for the Division, not just functional objectives.

Qualifications requirements:

1. BSc or higher degree in Chemistry or related position.
2. Several years’ progressive management experience in a quality function or closely related function.
3. Leadership experience in regulatory agency inspections.
4. Manufacturing experience (API based) desirable.

Other Benefits include:

1. Excellent opportunities for career enhancement and personal development.
2. Competitive base salary.
3. Annual bonus linked to business results.
4. A well-established further education program.
5. Pension scheme.
6. Private Healthcare.

HOW TO APPLY?
Make a difference today Suitable candidates should apply for this role by emailing your CV to Paula O’Doherty, HR Director paula.odoherty@skbiotek.ie. Closing date for applications is 5th February 2025.
SK pharmteco SM Europe is an equal opportunity employer.

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