ppIn this hybrid role, you will lead and coordinate quality activities to define and implement the global Quality Management Plan for the assigned scope.
You will work with global Quality Management, Site Management, and stakeholders to ensure GCP, ICH, and SOP compliance, drive risk management, and oversee corrective/preventive actions.
You will act as the primary QA contact, support audits and inspections, and prepare reports on quality matters.
This position offers the chance to shape quality governance across the delivery unit and collaborate with cross-functional teams to improve regulatory adherence and patient safety.
/pulliAdopt and implement the global Quality Management Plan within the scope of the assignment and lead Quality Management activities /liliIdentify risks through data review and quality control processes; support risk mitigation and CAPA planning /liliCollaborate with business lines and stakeholders to maintain quality in project delivery /liliContribute to a Delivery Unit/Sponsor-specific Quality Management Plan and Risk Management Program and monitor delivery /liliProvide guidance on Good Clinical Practice (GCP) compliance and SOPs; manage non-compliance and CAPA planning /liliInform Quality Management, business line,

and Quality Assurance of quality issues per SOPs /liliAssist during audits and regulatory inspections as required /liliServe as primary QA contact for quality matters at the assignment level and participate in meetings /liliPrepare periodic reports to heads of business lines on quality matters, risk assessments, and improvement initiatives /liliManage staff in line with policies, including performance, development, and HR actions /liliPerform other reasonable tasks as agreed with line manager /liliBachelor's Degree or equivalent; education, training, and experience may be substituted /liliSolid knowledge of SOPs, ICH, GCP, regulatory requirements, and quality management processes /liliKnowledge of National and International Regulations and Drug Development processes /liliExperience with CRO or Pharmaceutical industry operations /liliFamiliarity with IQVIA corporate standards and SOPs /liliStrong organizational, interpersonal, and communication skills /liliGood judgment, decision-making, and influencing/negotiation skills /liliProficient in Microsoft Office applications /liliExcellent problem-solving skills /liliAbility to travel within the region/country /liliAbility to lead and motivate a clinical team /liliAbility to establish and maintain effective working relationships with colleagues and clients /li /ul /p #J-*****-Ljbffr

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