Job DescriptionA leading company in the pharmaceutical industry is currently seeking a Director of Quality to join their team. The role will be challenging but also highly rewarding and this leader will be a key voice in the company. For the right executive, this is a fantastic opportunity with great growth prospects. Key duties include:1) Provide technical quality support for internal and external teams and projects2) Ensure robustness of process to meet CPPs and CQAs to achieve process reliability3) Oversee analytical methods validation and process validation for insulin analog drug substance and product4) Review and approve procedures, master batch records, or any other documentation to ensure the successful manufacture of the product5) Review and approve quality system records including change requests, deviations, and CAPA as necessary6) Provide quality input to new facility design changes as new needs are evaluated.7) Decision-maker for validation/qualification of insulin biosimilars and escalation of issues to management with a focus on problem-solving8) Oversee disposition of drug substance9) Ensure manufacturing and QC adherence to company policies and procedures, regulatory licenses, industry standards and GMP regulations10) Represent QA during site health authority inspections and business forums, including site leadership teams11) Ensure staff training and development12) Partner with and influence other departments and functions throughout the organization, including Operations, Site Quality, Regulatory Affairs and Technical Development and Services to implement ongoing product and process robustness to continuously improveCritical Requirements1) A university degree is required. Although all candidates are welcome and encouraged to apply, preference will be given to those with degrees in a relevant field2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)3) Recent experience in the pharmaceutical industry is strongly preferred4) Preference will be given to candidates with recent experience in quality managementIf you are qualified and looking to work with a well-established company - one of the top names in the industry - you should not let this opportunity pass by. However, for this Director of Quality role, you must be someone who is experienced and passionate about quality management.Compensation and Other DetailsBase Salary: Highly competitive package, commensurate with experience
- Published on 19 Nov 2023, 10:28 AM