Cpl, in partnership with SK biotek Swords are seeking to recruit an Associate Director of Quality Assurance on a permanent basis.
Reporting to the Quality Director, the successful candidate will play a lead role in the quality team on site. This position is critical to ensure sustainable compliance of the site as they continue to grow though expansion of the site and increase their customer portfolio.
This unique opportunity offers the successful individual to work on everything from pre-clinical to fully commercial products.
In a very high volume setting, you will be comfortable working in a matrix environment, using your ability to influence, manage and delegate.
You will be confident challenging others to ensure that quality and compliance is forefront of operations, whilst supporting your colleagues in ensuring that product is released and dispatched to meet customer timelines.
WHAT WILL YOU DO?
- Provide compliance leadership across the site ensuring the site operates to the applicable cGMP and international standards for our customers on a daily basis
- Use scientific judgment and risk analysis to develop solutions and mitigation strategies as the business requires.
- Support the effective transfer of NPIs in collaboration with the site cross functional and customer teams
- Mentor and coach the quality assurance team to ensure batch release, product performance, product quality reviews and other cGMP documentation, including SOPs, policies, and manufacturing documentation are completed to the required standards.
- Ensure appropriate and efficient systems are in place for investigation quality issues, such as complaints, deviations, OOS results, or audit observations; with robust root cause analysis, appropriate CAPAs and effectiveness review.
The successful candidate will possess strong Quality and people Management. The candidate must have a strong understanding of the key business drivers of the industry/organization. Candidates should hold at minimum a Bachelor’s Degree in Science, Engineering or similar technical discipline. Advanced qualifications are desirable and at least 10 years’ experience in the Pharmaceutical industry.
Excellent communication and organizational skills with demonstrated expertise to effectively communicate within all levels of the organization is required. Demonstrated ability to lead, cross functional teams and make decisions in pressurized situations to ensure compliance.
WHATS IN IT FOR YOU?
- A chance to work with a world leader in contract development and manufacturing in a fast passed, dynamic and growing company
- Excellent opportunities for career enhancement and personal development
- Competitive base salary
- Annual bonus linked to base salary
- A well-established further education program.
- Pension scheme
- Private health insurance
- Free onsite parking
- Subsidized canteen on site
This role is site based, however there will be flexibility to accommodate a level of WFH requests and needs.
ABOUT SK biotek Ireland?
SK biotek Ireland, a SK pharmteco company, is a global Contract Development & Manufacturing Company with state-of-the-art facilities in Korea and Ireland. We are part of the wider SK Holdings group with revenues of $95 billion in 2020. Our mission is to ‘make what matters’, from grams to tonnes, the Swords Campus has led the way in the development, scale-up and commercial manufacture of highly potent Chemical Intermediates and Active Pharmaceuticals Ingredients (APIs) for over 50 + years. With exceptional technical capabilities, people and plant we have made some of the world’s most important medicines and continue to do so. Further information on how we ‘make what matters’ can be found at https://vimeo.com/skpharmteco.
SK biotek Ireland are an equal opportunities employer.