(Snr) QA Manager

<h2>Job Overview:</h2><p style="margin: 0px;">♦ Assures clinical QA audit programs are executed per agreed standards and audits deliver value to the organization, with audit outcomes followed through to appropriate closure<br />♦ Leads scoping and execution of RC&QA improvement initiatives and supports execution of global improvement initiatives<br />♦ Ensure the consistent implementation, use and review of SOPs<br />♦ Escalate issues to management in a timely manner, implementing appropriate solutions including preventative actions<br />♦ Negotiate with functional and operational internal stakeholders to improve quality and increase efficiencies<br />♦ Analyse and interpret data in order to lead functional process improvement initiatives to drive efficiencies and effectiveness of Regulatory Compliance & Quality Assurance (RC&QA) processes<br />♦ Lead and effectively manage constructive crucial interactions with clients or regulatory agencies<br />♦ Lead functional process improvement initiatives to drive efficiencies and effectiveness ofRegulatory Compliance & Quality Assurance (RC&QA) processes<br />♦ Interpret applicable quality regulations/standards and create appropriate policies and procedures<br />♦ Lead interactions with clients or regulatory agencies<br />♦ Recruit, train, coach and develop individuals based on their development or business needs<br />♦ Complete thorough, timely and well documented performance evaluations providing objective feedback to the individual<br />♦ Ensure Regulatory Compliance and Quality Assurance (RC&QA) management<br />responsibilities, as indicated in applicable controlled documents, are followed<br />♦ Perform other duties, as assigned by management</p><h2>Education/Qualifications:</h2><p style="margin: 0px;">♦ A minimum of a Bachelor’s Degree in Life Sciences preferred (or equivalent Life Science experience)<br />♦ Experience may be substituted for education</p><h2>Experience:</h2><p style="margin: 0px;">♦ 8-10 years in regulatory environment (experience in GXP roles)<br />♦ Experience & regulatory expertise of industry quality systems/standards<br />♦ Ability to interpret applicable regulations/standards<br />♦ Ability to analyse and interpret data in order to lead process improvement initiatives</p><p style="margin: 0px;">♦ Ability to communicate and negotiate internal stakeholders effectively</p><p style="margin: 0px;"> </p>