Job Description Summary<\/p>\n
\tThe GCP Compliance Manager (EMEA Hub) is accountable for the compliance oversight and control of regulated GCO activities focusing on EMEA Hub & Country level delivery including country trial level conduct as per country assignment.
\n\tThis role contributes to all compliance activities supporting the three pillars of GCP Compliance, issue management, audits & inspections as per country assignment and GCO self-strategy delivery.
\n\tThe GCP Compliance Manager (EMEA Hub) is the single point of contact for EMEA Hub & Country team members, providing day-to-day support and ongoing quality oversight.
\n\tThis role promotes a product quality culture within GCO supporting the GCP Compliance Head (EMEA hub), focusing on quality and compliance being increased and sustained and on active risk management.<\/p>\n
Job Description<\/p>\n
Major accountabilities: <\/p>\n
\tAccountable for the compliance oversight and control of regulated GCO activities focusing on EMEA Hub & Country level delivery including country trial level conduct as per country assignment.
\n\tSingle point of contact for EMEA Hub & Country team members for GCP Compliance.
\n\tAs per focus area and assignment, management and day-to-day support provided in program\/trial level quality issues, deviations and quality events management.
\n\tCoordination and support to program\/trial delivery teams for audits and inspections based on trials\u2019 selection and audit\/inspection scope.
\n\tDelivery of the GCO self-assessment strategy related checks and controls.
\n\tSupport cross-functions risk assessments if\u00a0program\/trial\/country\u00a0level in scope and contribute to the monitoring of relevant\u00a0indicators\/metrics\/thresholds.<\/p>\n
Activities & Interfaces:<\/p>\n
\tContribute to the execution of the GCO GCP Compliance strategy under the leadership of the GCP Compliance Head (EMEA Hub).
\n\tDrive the compliance oversight and control of regulated GCO activities focusing on EMEA Hub & Country level delivery including country trial level conduct as per country assignment, working closely with the Hub & Country teams members, the relevant functions across GCO, involving and collaborating as required with GDD and the wider organization, such as Quality Assurance.
\n\tBe the single point of contact for EMEA Hub & Country team members as per country assignment for GCP Compliance.
\n\tManage and provide day-to-day support to the EMEA Hub & Country team members in Hub & Country level quality issues, deviations and quality events management, providing expertise in investigation, RCA and CAPA development. Involve and collaborate as needed with the relevant functions across GCO,
\n\tGDD and the wider organization, such as Quality Assurance.
\n\tCoordinate and support Hub & Country related audits & inspections (e.g. Clinical Development Audit, Investigator Site Inspection) as per selection and scope, from preparation to CAPA & effectiveness checks completion, working closely with Quality Assurance. Support and conduct of inspection readiness as per scope.
\n\tDeliver the GCO self-assessment strategy related checks and controls as assigned and share insights within the GCP Compliance team based on the day-to-day support provided.
\n\tSupport cross-functions risk assessments if\u00a0program\/trial\/country\u00a0level in scope, working with Hub & Country Teams and the relevant GCO functions.
\n\tContribute to the monitoring relevant indicators\/ metrics\/thresholds ensuring the detection of unreported issues, trends and early signals of risks at Hub & Country level.
\n\tParticipate in relevant GCO, PTC, GCP Compliance team meetings. May attend as needed or be delegated by the GCP Compliance Head (EMEA hub) to participate in relevant boards, committees and escalation meetings (e.g. GCO Quality Review Board; Issues Management & Escalations Triaging Meetings).
\n\tContribute to build a network of managers and other relevant stakeholders with other functions, compliance, process, training and risk groups across GCO, in GDD and within the wider organization, such as Quality Assurance.
\n\tPromote a compliance culture within GCO, advocating the adherence to highest standards and ethical integrity.<\/p>\n
Education:<\/p>\n
\tAdvanced degree in science, engineering or relevant discipline.<\/p>\n
Experience\/Professional Requirement:<\/p>\n
\t8+ years industry experience specifically in clinical operations and clinical site management with a strong understanding of clinical research international standards and regulatory requirements from Health Authorities. Audits and inspections experience highly desirable.
\n\tOrganizational and analytical skills associated with an aptitude in quality management and continuous improvement.
\n\tCritical thinking ability and risk management and risk-based knowledge and mindset.
\n\tAbility in partnering with a proactive and solution-oriented mindset.
\n\tStrong skills to facilitate\/optimize contribution of team members as individuals and members of a cohesive team.
\n\tAbility to work effectively in a matrix cross-functional environment.
\n\tStrong capacity for working independently with minimal guidance.
\n\tAbility to make & communicate difficult decisions, associated with strong written and verbal communication skills.
\n\tSelf-awareness, willingness to further develop own strengths and explore opportunities for improvement.<\/p>\n
Apply via company website ( http:\/\/www.novartis.com ) or<\/p>\n
novartis.wd3.myworkdayjobs.com<\/p>\n
<\/p>\n","protected":false},"author":2,"featured_media":0,"template":"","meta":{"_promoted":"","_job_location":"","_application":"http:\/\/novartis.wd3.myworkdayjobs.com","_company_name":"Novartis","_company_website":"http:\/\/www.novartis.com","_company_tagline":"Novartis provides healthcare solutions that improve and extend people\u2019s lives. We use science-based innovation to address some of society\u2019s most challenging healthcare issues. We discover and develop breakthrough treatments and find new ways to deliver them to as many people as possible. Our com... read morepany is focused on industry-leading divisions with innovation power and global scale: pharmaceuticals, eye care and generic medicines Novartis is headquartered in Basel, Switzerland. Novartis Group companies employ approximately 120,000 associates and its products are available in more than 180 countries around the world. Novartis South Africa (Pty) Ltd 72 Steel Road Spartan ZA- Kempton Park, Gauteng 1619 South Africa","_company_twitter":"","_company_video":"","_filled":0,"_featured":0,"_remote_position":0,"_job_salary":"","_job_salary_currency":"","_job_salary_unit":""},"job_listing_region":[11],"job-types":[12],"class_list":["post-34464","job_listing","type-job_listing","status-expired","hentry","job_listing_region-gauteng","job-type-full-time"],"jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/job-listings\/34464","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/job-listings"}],"about":[{"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/types\/job_listing"}],"author":[{"embeddable":true,"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/users\/2"}],"wp:attachment":[{"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/media?parent=34464"}],"wp:term":[{"taxonomy":"job_listing_region","embeddable":true,"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/job_listing_region?post=34464"},{"taxonomy":"job_listing_type","embeddable":true,"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/job-types?post=34464"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}