Job Title: Associate Director QualityLocation: CorkWe are partnering with a leading global medical technologies company as they expand into pharmaceutical manufacturing at their Cork site. This is a unique opportunity to join the business at a pivotal moment of transformation in a newly created leadership role.As an Associate Director of Quality & Qualified Person (QP), you will play a key role in ensuring that their pharmaceutical products meet the highest standards of quality, safety, and regulatory compliance.Job Purpose:The Associate Director of Quality and QP will provide strategic leadership in quality assurance and regulatory compliance to guarantee the excellence of all pharmaceutical products. Key responsibilities include overseeing the Pharmaceutical Quality Management System (PQS), supporting the site QP, and ensuring compliance with industry regulations.Key Responsibilities:Talent Management: Recruit, mentor, and empower talent to foster a diverse and inclusive workplace.Leadership: Lead the Pharmaceutical Quality team, ensuring they are equipped with the necessary skills and knowledge to meet regulatory standards and drive process optimisation.Pharmaceutical Quality System: Apply comprehensive knowledge of quality systems to ensure product quality and compliance with GMP Guidance and regulatory requirements.Regulatory Compliance: Ensure efficient compliance with regulations through effective quality systems and communication with regulatory authorities.Operational Management: Prepare for audits and regulatory inspections, lead audit teams, and collaborate cross-functionally to address observations and ensure ongoing compliance.Crisis Management: Lead complex analysis and decisions related to quality-related issues.Continuous Improvement: Foster an environment of innovation and improvement in the Pharmaceutical Quality System (PQS).New Product Introduction (NPI): Collaborate with NPI teams to ensure adherence to cGMP standards and regulatory expectations in product design and processes.Education & Experience:Bachelor's degree in science or engineering (Master's preferred)10+ years of experience in pharmaceutical/biotech manufacturing, with significant time in Quality Assurance (QA), Quality Control (QC), or Compliance roles.5+ years in leadership positions within quality-related functions.Strong knowledge of cGMP, ICH guidelines, EU GMP Annexes, and FDA/HPRA expectations.Experience in regulatory inspections (e.g., HPRA, FDA).Medical device manufacturing experience is advantageous.QP experience is desirable.For further information on this Associate Director Quality role in Cork, please contact Caroline Kingston at +353 868395531 or email caroline@hero.ie. Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/.Please note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval. Data can only be transferred outside of the EEA based on standards contractual clauses, to a country for which an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review your data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.
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