QA Operations Manager About SK biotek: SK biotek Ireland, an SK pharmteco company, 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 the wider SK Inc. with revenues of $88 billion in 2022. Our mission is to 'make what matters for a healthy, happier world', from grams to tonnes. The Swords Campus has led the way in the development, scale-up, and commercial manufacture of Active Pharmaceuticals Ingredients (APIs), Highly Potent Active Pharmaceuticals Ingredients, and Chemical Intermediates for almost 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 https://vimeo.com/skpharmteco.
Current Need: The SK biotek Ireland here at the Swords Campus is looking for a QA Operations Manager on a permanent contract.
Position Description: The QA Operations Manager oversees critical quality activities including responsibility for managing the Customer representative team and the Quality Assurance Operations plant support and release team. This role also involves managing a portfolio of customer quality activities including the quality management and oversight of a portfolio of NPIs from development through clinical to commercial product, providing QA support to the site, the release of intermediate and API batches, and participating in audits by regulatory agencies and customers. This role will deputise for the Quality Assurance Associate Director as required.
Minimum Requirements: A Bachelor's or Master's degree in Chemistry or a related scientific field is required, with a minimum of 3 years of experience managing teams in the pharmaceutical industry, preferably in a Customer facing Quality Assurance role.The QA Operations Manager must possess strong initiative and be capable of working both independently and collaboratively across the organisation.The ideal candidate will demonstrate proficiency in the following areas: Leading and directing the QA teams to support SK biotek operations and customers.Managing a portfolio of New Product Introductions from development to clinical to commercial.Building effective working relationships.Providing regular feedback and coaching.Developing direct reports through coaching, mentoring, training, and providing them with specialized projects, in line with performance connections process.Recruiting and training new team members as required.Supporting quality activities for the introduction and validation of all new processes.Excellence in communication, collaboration, working with minimum direction, 'can do, solutions-oriented' attitude, leadership, problem-solving, and driving continuous improvement.Exceptional time management and organizational abilities, coupled with a track record of effectively handling multiple tasks and customers simultaneously.In-depth knowledge of cGMP principles relevant to API manufacturing, including ICH Q10 and Q7.Adeptness in interpreting industry regulations and identifying potential gaps in current site and QA procedures.Capacity to manage numerous projects concurrently and meet strict deadlines.Strong troubleshooting skills and a sound technical background in quality within the pharmaceutical manufacturing sector.Ensuring that a culture of safety is maintained and advanced in Quality Assurance.Desired/Advantages: Experience/Skills in Project ManagementLean Six SigmaAuditing/AuditorQRMBusiness and Financial AcumenDigitalisationISPE Quality Cultural ExcellenceOrganisation designWhy choose a career at SK biotek? A career with purpose and a chance to work with a world leader in contract development and manufacturing in a fast-paced, dynamic, and growing organisation. Here at SK biotek Ireland, we believe we enhance patients' lives and we need you! It reminds each one of us that what we do matters, and our mission is to 'make what matters for a healthy, happier world' - whatever your title, whatever your role, you act as a catalyst in a chain of events that helps millions of people all over the globe. By choosing a career with SK biotek Ireland, you'll join a team of passionate people working together to improve lives by making what matters for a healthy, happier world.
Other Benefits include: Excellent opportunities for career enhancement and personal developmentCompetitive base salaryAnnual bonus linked to business resultsA well-established further education programPension schemePrivate healthcare
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