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Haleon describes itself as a world-leading consumer health company with a portfolio of brands built on science, innovation, and human understanding and is worki
Clinical Development Quality Assurance, Associate Director
Location
Worldwide
Posted
54 days ago
Salary
0
Seniority
Lead
No structured requirement data.
Job Description
Clinical Development Quality Assurance, Associate Director
Haleon
Role Description This role is responsible for providing overall quality and compliance during the clinical development processes (GCP and GLP), across all categories: - Plan and conduct GCP/GLP/GCLP audits independently or as a Lead or as a team member or in a support role. - Support functional activities related to pre-clinical and clinical development to ensure these activities are conducted in accordance with applicable regulatory requirements, guidelines, laws, and established quality standards and practices. - Serve as a GCP and GLP partner with stakeholders to solve compliance issues, drive quality improvements and improve animal, human research practices, patient safety, and data integrity. Accountabilities/Responsibilities - Plan and conduct global GCP/GLP/GCLP audits independently / as a Lead / as a team member / in a supportive role. - Communicate and document audit findings, compile corrective and preventive action (CAPA) evidence. - Maintain audit program and/or contribute to elaborate audit program. The scope of the audit program includes clinical investigator sites, external service providers, and internal processes. - Support the development and maintenance of Clinical Quality Schedule in Master Services Agreements. - Coordinate and support internal stakeholders during regulatory inspections (e.g., FDA, EMA, MHRA). - Assist in the development and implementation of a Quality Management System and SOPs for clinical/non-clinical activities in compliance with applicable GCP and GLP regulations; participate in maintenance of CDA&I SOPs. - Escalate and investigate significant compliance issues to line management. - Mentor and support other members of CDA&I. - Provide expert advice for GCP/GLP compliance strategy, quality improvement, process and program initiatives and risk assessments. - Support Significant Quality Investigations (SQIs) and Serious Breaches (SBs) for human subject research activities, where required. - Train/coach, guide, and influence the respective business functions on GCP/GLP procedures, compliance, and regulatory standards, enhance quality culture. - Build and maintain beneficial working relationships with internal and external stakeholders. Qualifications - Minimum Level of Education: Bachelor of Science (BS) Degree. - Preferred Level of Education: Master of Science Degree or PhD in Biology, Biochemistry, or equivalent. - Job-Related Experience: 10+ years of pharmaceutical industry experience with at least 5 to 7 years in clinical quality assurance and auditing. Competencies and Skills - Proven ability to influence and negotiate with internal and external stakeholders. - Expert knowledge of applicable Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) regulatory requirements and guidelines, and company policies & procedures. - Detailed knowledge of human subject research activities, clinical development processes and R&D systems. - Self-motivated and quick learner who proactively shares knowledge and welcomes knowledge and feedback from other team members. - Ability to deliver key process improvement initiatives. - Ability to adapt to changing business and risk environment. - Ability to work independently and as part of a team. - High degree of organizational awareness and working towards resolution with compliance issues. - Demonstrated ability for good verbal, written and presentation skills. - Ability and desire for domestic and international travel. - Ability to interact and work remotely either part or full time. Equal Opportunities Haleon are committed to mobilising our purpose in a way that represents the diverse consumers and communities who rely on our brands every day. It guides us in creating an inclusive culture, where different backgrounds and views are valued and respected – all in support of understanding and best serving the needs of our consumers and unleashing the full potential of our people. During the application process, we may ask you to share some personal information, which is entirely voluntary. This information ensures we meet certain regulatory and reporting obligations and supports the development, refinement, and execution of our inclusion and belonging programmes that are open to all Haleon employees. The personal information you provide will be kept confidential, used only for legitimate business purposes, and will never be used in making any employment decisions, including hiring decisions. Adjustment or Accommodations Request If you require a reasonable adjustment or accommodation or other assistance to apply for a job at Haleon at any stage of the application process, please let your recruiter know by providing them with a description of specific adjustments you are requesting. We’ll provide all reasonable adjustments to support you throughout the recruitment process and treat all information you provide us in confidence. Note to Candidates The Haleon recruitment team will contact you using a Haleon email account (@haleon.com). If you are not sure whether the email you received is from Haleon, please get in touch.
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