Job Title

THE COMPANY YOU WOULD BE JOININGThis pharmaceutical innovator works with pharma companies across Australia and internationally to translate laboratory discoveries to pharma medicines.Their headquarters are purpose built and equipped with state-of-the-art technologies for R&D, and they specialise in taking a lead compound or idea to final product ready for clinical trials, helping solve pharmaceutical problems.WHAT YOU WILL LEAD & GROWThis Head of Quality position reports to the executive team and plays a key role in the effective and compliant operation of the companys GMP facility. The position is responsible for setting the strategic direction of the quality and compliance agenda and has strategic oversight of all quality and compliance functions.Critical to this role, is strengthening of internal capabilities to achieve project outcomes whilst maintaining a strong focus on quality, compliance and patient safety.The primary objective of the position is to guide the business and support staff members on maintaining a GMP compliant facility licensed through TGA/FDA. This includes but is not limited to developing QMS, approving documentation, training staff, providing guidance on equipment/facilities/process validation, utilising experience to build processes etc.Maintaining operational quality controls and managing risks, along with designing methods for meeting company benchmarks and goals, while prioritising and implementing effective strategies to ensure corrective/preventative actions are completed is key to this role.This position will oversee the quality function to ensure completion of tasks to agreed deadlines, including effective investigations and resolution.You will be responsible for 3 direct reports, so you must have strong leadership capabilities, with quality and compliance management experience as you will maintain TGA/FDA GMP license for the facility, while managing effective risk management of new product introductions.You will liaise with TGA/FDA and other regulatory bodies and liaise with clinical trial sponsors and other 3rd parties while leading the quality and regulatory affairs team. You will oversee qualification of the GMP facility and licensing and communicate quality requirements to the rest of the business.You will approve/reject starting materials, packaging materials, intermediates and finished products and ensure QC testing is performed to approved specifications and test methods.You will review analysis (including that performed at contract laboratories).This role is a delegate appointed by the Board of Directors for release of finished products for supply to clinical trials on behalf of the organisation.WHAT EXPERIENCE & QUALIFICATIONS WILL YOU NEED TO GET THE JOB?Tertiary qualifications in science, engineering or related field.10 years GMP experience within pharmaceutical industry in a similar role.Previous experience leading quality functional groups.Understanding of quality control requirements for finished products.Extensive knowledge of formulation of non-sterile dosage forms (liquids, nasal sprays, capsules, creams, suspensions).Experience utilising eQMS systems.Training in release for supply processes.WHAT DO YOU DO NOW?Please ''apply now'' quoting reference number 3708 or call Scott Della-Pietra on 8310.9266. Please note, your details/resume will not be sent anywhere without a formal interview and, if successful, your subsequent prior permission. Personal information provided will be used for recruitment purposes only and be treated in the strictest confidence. Only shortlisted candidates will be contacted. #J-18808-Ljbffr